Download PDF

Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis

Summary
EudraCT number	2015-001758-14
Trial protocol	DE ES NL BG HU BE IT
Global end of trial date	21 Mar 2018

Results information
Results version number	v1
This version publication date	26 Apr 2019
First version publication date	26 Apr 2019
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

201677

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom,

Public contact

GSK Response Center, GSK Response Center, 8664357343 1, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

30 Jul 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Mar 2018

Was the trial ended prematurely?

Yes

Main objective of the trial

To investigate the efficacy of sirukumab (100 mg q2w for 12 months) as compared to placebo, each administered in addition to a 6-month prednisone treatment regimen

Protection of trial subjects

Not Applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Oct 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 19

Country: Number of subjects enrolled

Belgium: 14

Country: Number of subjects enrolled

Bulgaria: 4

Country: Number of subjects enrolled

France: 5

Country: Number of subjects enrolled

Germany: 42

Country: Number of subjects enrolled

Hungary: 3

Country: Number of subjects enrolled

Italy: 11

Country: Number of subjects enrolled

Netherlands: 6

Country: Number of subjects enrolled

New Zealand: 4

Country: Number of subjects enrolled

Spain: 11

Country: Number of subjects enrolled

United Kingdom: 15

Country: Number of subjects enrolled

United States: 27

Worldwide total number of subjects

161

EEA total number of subjects

111

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

112

85 years and over

Subject disposition

Top of page

Recruitment details

This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of sirukumab in treatment of participants with Giant Cell Arteritis (GCA). A total of 161 participants were enrolled.

Screening details

This study was conducted in 2 distinct parts (Part A and Part B), Part A was a 52-week double-blind treatment phase and Part B was a 104-week long-term extension phase with the option to receive open-label sirukumab (SIR) (up to a 52-week duration of open-label treatment). This study was terminated early by sponsor.

Period 1 title

Part A (52 weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Part A:SIR 100 mg SC q2w+6 month prednisone

Arm description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Arm type

Experimental

Investigational medicinal product name

Sirukumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Part A:SIR 100 mg SC q2w+3 month prednisone

Arm description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Arm type

Experimental

Investigational medicinal product name

Sirukumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Part A:SIR 50 mg SC q4w+6 month prednisone

Arm description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Arm type

Experimental

Investigational medicinal product name

Sirukumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Part A:Placebo SC q2w + 6 month prednisone

Arm description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Arm type

Placebo

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous every 2 weeks (treatment arms D & E)

Part A:Placebo SC q2w+12 month prednisone

Arm description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Arm type

Placebo

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous every 2 weeks (treatment arms D & E)

Number of subjects in period 1	Part A:SIR 100 mg SC q2w+6 month prednisone	Part A:SIR 100 mg SC q2w+3 month prednisone	Part A:SIR 50 mg SC q4w+6 month prednisone	Part A:Placebo SC q2w + 6 month prednisone	Part A:Placebo SC q2w+12 month prednisone
Started	42	39	26	27	27
Completed Part A and didn’t enter Part B	1 ^[1]	0 ^[2]	1 ^[3]	0 ^[4]	0 ^[5]
Completed	8	5	4	5	4
Not completed	34	34	22	22	23
Physician decision	1	4	3	1	-
Consent withdrawn by subject	6	6	1	3	3
Sponsor request	24	24	18	18	19
Unknown	2	-	-	-	-
Lost to follow-up	-	-	-	-	1
Protocol deviation	1	-	-	-	-

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: 2 Participants completed Part A then withdrew. They are counted again in withdrawals

Period 2 title

Part B (104 weeks)

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part B:SIR 100 mg SC q2w+6 month prednisone

Arm description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A

Arm type

Experimental

Investigational medicinal product name

Sirukumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Part B:SIR 100 mg SC q2w+3 month prednisone

Arm description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A

Arm type

Experimental

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Investigational medicinal product name

Sirukumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

Part B:SIR 50 mg SC q4w+6 month prednisone

Arm description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A

Arm type

Experimental

Investigational medicinal product name

Sirukumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

1.0 milliliter Pre-filled syringe by subcutaneous route, every 2 weeks (treatment arms A & B) and subcutaneous, every 4 weeks (treatment arm C)

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Part B:Placebo SC q2w + 6 month prednisone

Arm description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A

Arm type

Experimental

Investigational medicinal product name

Prednisone

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral tablets, Up to-60 mg/day 20-60 mg/day open-label then 0-18 mg/day taper (blinded)

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous every 2 weeks (treatment arms D & E)

Part B:Placebo SC q2w + 12 month prednisone

Arm description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous every 2 weeks (treatment arms D & E)

Number of subjects in period 2	Part B:SIR 100 mg SC q2w+6 month prednisone	Part B:SIR 100 mg SC q2w+3 month prednisone	Part B:SIR 50 mg SC q4w+6 month prednisone	Part B:Placebo SC q2w + 6 month prednisone	Part B:Placebo SC q2w + 12 month prednisone
Started	8	5	4	5	4
Completed	0	0	0	0	0
Not completed	8	5	4	5	4
Sponsor request	8	5	3	5	4
Lost to follow-up	-	-	1	-	-

Baseline characteristics

Top of page

Reporting group title

Part A (52 weeks)

Reporting group description

Reporting group values	Part A (52 weeks)	Total
Number of subjects	161	161
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	42	42
From 65-84 years	112	112
85 years and over	7	7
Age Continuous
Units: Years
arithmetic mean (standard deviation)	69.6 ± 7.85	-
Sex: Female, Male
Units: Subjects
Female	124	124
Male	37	37
Race, Customized
Units: Subjects
African American/African Heritage	1	1
White: Arabic/North African Heritage	2	2
White/Caucasian/European Heritage	156	156
Mixed Race	2	2

End points

Top of page

Reporting group title

Part A:SIR 100 mg SC q2w+6 month prednisone

Reporting group description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Reporting group title

Part A:SIR 100 mg SC q2w+3 month prednisone

Reporting group description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Reporting group title

Part A:SIR 50 mg SC q4w+6 month prednisone

Reporting group description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Reporting group title

Part A:Placebo SC q2w + 6 month prednisone

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Reporting group title

Part A:Placebo SC q2w+12 month prednisone

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Reporting group title

Part B:SIR 100 mg SC q2w+6 month prednisone

Reporting group description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A

Reporting group title

Part B:SIR 100 mg SC q2w+3 month prednisone

Reporting group description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A

Reporting group title

Part B:SIR 50 mg SC q4w+6 month prednisone

Reporting group description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A

Reporting group title

Part B:Placebo SC q2w + 6 month prednisone

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A

Reporting group title

Part B:Placebo SC q2w + 12 month prednisone

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A

Subject analysis set title

SIR100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

SIR 50 mg SC q4w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

Placebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartA:SIR 50 mg SC q4w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartA:SIR 50 mg SC q4w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:SIR 50 mg SC q4w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+3 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartA:SIR 50 mg SC q4w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 12 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartA:SIR 100 mg SC q2w+3 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartA:SIR 50 mg SC q4w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartA:Placebo SC q2w + 12 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+3 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:SIR 50 mg SC q4w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 12 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+3 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:SIR 50 mg SC q4w+6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 6 month Prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:SIR 50 mg SC q4w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartBSIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartBSIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartBSIR 50 mg SC q4w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartBPlacebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartBPlacebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:SIR 50 mg SC q4w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+3 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 12 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Subject analysis set title

PartB:SIR 100 mg SC q2w+6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Subject analysis set title

PartB:Placebo SC q2w + 6 month prednisone

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Primary: Part A: Number of participants in sustained remission at Week 52

Top of page

End point title

Part A: Number of participants in sustained remission at Week 52 ^[1]

End point description

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.

End point type

Primary

End point timeframe

Week 52

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was performed

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	17	13	9	9	7
Units: Participants	3	2	1	0	0

No statistical analyses for this end point

Secondary: Part B: Number of participants who remained in sustained remission without requirement for rescue therapy or treatment change at Week 24

Top of page

End point title

Part B: Number of participants who remained in sustained remission without requirement for rescue therapy or treatment change at Week 24

End point description

Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.

End point type

Secondary

End point timeframe

Week 24

End point values	Part B:SIR 100 mg SC q2w+6 month prednisone	Part B:SIR 100 mg SC q2w+3 month prednisone	Part B:SIR 50 mg SC q4w+6 month prednisone	Part B:Placebo SC q2w + 6 month prednisone	Part B:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone
Number of subjects analysed	2	2	1	0 ^[2]	0 ^[3]	2
Units: Participants	99999	99999	99999			99999

Notes
[2] - Data for number of participants in sustained remission over time for Part B is presented.
[3] - Data for number of participants in sustained remission over time for Part B is presented.

No statistical analyses for this end point

Secondary: Part A: Cumulative prednisone dose over time

Top of page

End point title

Part A: Cumulative prednisone dose over time

End point description

Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Milligrams
arithmetic mean (standard deviation)
Week 2, n= 40,39,26,27,26	439.575 ± 237.8990	464.923 ± 299.6445	424.577 ± 270.2183	432.815 ± 315.6851	430.846 ± 241.3540
Week 4,n=40,39,26,25,27	701.100 ± 370.9798	741.115 ± 436.4205	701.192 ± 439.7251	705.480 ± 601.9706	751.407 ± 431.3442
Week 8,n=37, 37,26,23,26	1086.676 ± 600.7400	987.730 ± 559.4458	1014.731 ± 592.3515	1161.391 ± 1202.8504	1129.077 ± 546.8037
Week 12,n=34,32,24,22,24	1344.441 ± 779.6775	1063.773 ± 619.4002	1208.167 ± 650.6975	1379.409 ± 1255.4397	1462.917 ± 630.1717
Week 16,n=32,30,24,22,22	1545.602 ± 964.3264	1182.288 ± 718.6186	1348.750 ± 689.2484	1672.795 ± 1261.7121	1729.977 ± 701.3734
Week 20,n=29,27,21,24,19	1690.302 ± 1173.6005	1339.546 ± 888.5007	1475.786 ± 734.7667	1646.177 ± 701.5240	2041.632 ± 771.3504
Week 24,n=30,25,19,18,17	1878.458 ± 1333.1175	1495.015 ± 1055.9615	1626.342 ± 813.8284	1917.444 ± 861.6887	2299.471 ± 840.8758
Week 28,n=24,23,15,17,15	2000.813 ± 1594.5982	1575.549 ± 1170.7294	1797.533 ± 933.3753	2141.294 ± 1082.2754	2387.800 ± 741.1663
Week 32,n=19,21,13,15,18	2216.000 ± 1953.8211	1716.863 ± 1328.1426	1859.346 ± 858.5431	2531.417 ± 1327.9125	2404.500 ± 808.8642
Week 36,n=19,17,14,13,14	2321.711 ± 2090.2393	1803.919 ± 1536.5304	1705.214 ± 802.8858	2617.817 ± 1636.2516	2717.696 ± 897.0689
Week 40,n=18,15,11,13,12	2003.264 ± 1426.0271	2023.342 ± 1651.4092	1842.500 ± 904.4136	2960.144 ± 1736.2249	2963.865 ± 909.0195
Week 44,n=17,13,10,12,13	2051.603 ± 1588.9627	1481.115 ± 1381.3957	1980.733 ± 1444.8664	2783.542 ± 1776.0608	2954.760 ± 1022.5491
Week 48,n=10,16,9,8,11	1821.325 ± 1139.5986	1601.656 ± 1362.9717	1562.333 ± 828.5650	2859.208 ± 1882.7422	3167.898 ± 1195.4020
Week 52,n=11,10,6,7,6	2974.295 ± 2966.6259	2418.213 ± 2085.2345	2556.222 ± 1363.1832	3157.054 ± 1988.0610	3603.229 ± 1477.6777

No statistical analyses for this end point

Secondary: Part B: Number of participants in sustained remission over time

Top of page

End point title

Part B: Number of participants in sustained remission over time

End point description

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. ITT-Part B Population. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.

End point type

Secondary

End point timeframe

Weeks 4, 8 and 12

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	2	1	99999 ^[4]	99999 ^[5]
Units: Participants
Week 4,n=1,1,1,0,0	1	1	1	99999	99999
Week 8,n=1,0,1,0,0	1	99999	1	99999	99999
Week 12,n=1,0,0,0,0	1	99999	99999	99999	99999

Notes
[4] - Data for number of participants in sustained remission over time for Part B is presented.
[5] - Data for number of participants in sustained remission over time for Part B is presented.

No statistical analyses for this end point

Secondary: Part A: Time to first disease flare after clinical remission

Top of page

End point title

Part A: Time to first disease flare after clinical remission

End point description

Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.

End point type

Secondary

End point timeframe

Week 52

End point values	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone	PartA:SIR 100 mg SC q2w+6 month prednisone
Number of subjects analysed	39	26	27	27	40
Units: Days
median (inter-quartile range (Q1-Q3))	99999 (-99999 to 99999)	99999 (176.0 to 99999)	99999 (99.0 to 99999)	99999 (183.0 to 99999)	99999 (-99999 to 99999)

No statistical analyses for this end point

Secondary: Part B: Time to first disease flare for participants in sustained remission

Top of page

End point title

Part B: Time to first disease flare for participants in sustained remission

End point description

Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.

End point type

Secondary

End point timeframe

Week 52

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	2	1	0 ^[6]	0 ^[7]
Units: Days
median (inter-quartile range (Q1-Q3))	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	( to )	( to )

Notes
[6] - Data for number of participants in sustained remission over time for Part B is presented.
[7] - Data for number of participants in sustained remission over time for Part B is presented.

No statistical analyses for this end point

Secondary: Part A: Number of disease flares over time

Top of page

End point title

Part A: Number of disease flares over time

End point description

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Disease flares
Week 2, n=38, 39,26,25,27	1	2	2	0	2
Week 4, n=37,37,25,23,27	3	4	3	0	2
Week 8, n=34,32,24,23,23	2	6	3	1	5
Week 12, n=32,29,24,22,22	4	9	4	4	4
Week 16, n=28,26,22,19,19	4	9	5	9	4
Week 20, n=26,23,19,18,16	4	9	6	10	3
Week 24, n=23,21,16,17,16	6	9	8	11	5
Week 28, n=19,18,12,14,14	5	8	8	11	5
Week 32, n=19,15,10,12,13	5	8	5	10	6
Week 36, n=15,13,10,12,13	3	8	5	10	6
Week 40, n=15,11,9,10,10	2	7	5	8	5
Week 44, n=11,11,6,8,9	1	8	3	6	7
Week 48, n=9,8,5,8,5	1	4	1	7	3
Week 52, n=9,5,5,5,4	1	2	1	7	4

No statistical analyses for this end point

Secondary: Part A: Number of participants with at least one hospitalization for disease flare

Top of page

End point title

Part A: Number of participants with at least one hospitalization for disease flare

End point description

Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Participants
Week 2, n=38, 39,26,25,27	0	0	0	0	0
Week 4, n=37,37,25,23,27	0	0	0	0	0
Week 8, n=34,32,24,23,23	0	0	0	0	0
Week 12, n=32,29,24,22,22	1	0	0	0	0
Week 16, n=28,26,22,19,19	1	0	0	0	0
Week 20, n=26,23,19,18,16	1	0	1	0	0
Week 24, n=23,21,16,17,16	1	0	1	0	0
Week 28, n=19,18,12,14,14	0	0	1	0	0
Week 32, n=19,15,10,12,13	0	0	0	0	0
Week 36, n=15,13,10,12,13	0	0	0	0	0
Week 40, n=15,11,9,10,10	0	0	0	0	0
Week 44, n=11,11,6,8,9	0	0	0	0	0
Week 48, n=9,8,5,8,5	0	0	0	0	0
Week 52, n=9,5,5,5,4	0	0	0	0	0

No statistical analyses for this end point

Secondary: Part A: Number of hospitalizations for disease flare over time

Top of page

End point title

Part A: Number of hospitalizations for disease flare over time

End point description

Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Number of Hospitalizations
Week 2, n=38, 39,26,25,27	0	0	0	0	0
Week 4, n=37,37,25,23,27	0	0	0	0	0
Week 8, n=34,32,24,23,23	0	0	0	0	0
Week 12, n=32,29,24,22,22	2	0	0	0	0
Week 16, n=28,26,22,19,19	2	0	0	0	0
Week 20, n=26,23,19,18,16	2	0	1	0	0
Week 24, n=23,21,16,17,16	2	0	1	0	0
Week 28, n=19,18,12,14,14	0	0	1	0	0
Week 32, n=19,15,10,12,13	0	0	0	0	0
Week 36, n=15,13,10,12,13	0	0	0	0	0
Week 40, n=15,11,9,10,10	0	0	0	0	0
Week 44, n=11,11,6,8,9	0	0	0	0	0
Week 48, n=9,8,5,8,5	0	0	0	0	0
Week 52, n=9,5,5,5,4	0	0	0	0	0

No statistical analyses for this end point

Secondary: Part A: Mean 36-item Short Form health survey version 2 (SF-36 v2) acute score over time

Top of page

End point title

Part A: Mean 36-item Short Form health survey version 2 (SF-36 v2) acute score over time

End point description

SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 12, 24, 36, 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
PCS,Baseline, n=42,38,25,23,27	49.258 ± 11.7655	43.271 ± 12.3169	42.919 ± 11.7298	49.240 ± 9.2759	45.470 ± 12.8498
PCS,Week 12, n=31,28,24,22,22	51.519 ± 10.5352	43.128 ± 11.4559	43.655 ± 11.0324	48.552 ± 10.4184	47.007 ± 12.8749
PCS,Week 24, n=23,20,15,17,16	50.023 ± 11.4731	45.677 ± 12.1192	45.097 ± 15.0552	46.911 ± 9.2901	44.280 ± 11.4740
PCS,Week 36, n=15,13,10,12,13	51.989 ± 10.7521	47.069 ± 12.7103	46.005 ± 12.2496	48.336 ± 10.0154	44.946 ± 10.1921
PCS,Week 52, n=9,5,5,5,4	50.269 ± 10.8743	53.690 ± 7.9049	53.608 ± 7.7721	52.026 ± 6.4892	53.143 ± 12.8351
MCS,Week 12, n=31,28,24,22,22	43.955 ± 4.6164	45.264 ± 5.7982	46.393 ± 6.1792	43.746 ± 5.3179	43.182 ± 4.6707
MCS,Week 24, n=23,20,15,17,16	44.538 ± 5.6952	45.954 ± 5.4884	44.877 ± 6.5210	45.372 ± 6.4561	45.526 ± 5.8924
MCS,Week 36, n=15,13,10,12,13	45.258 ± 5.2429	45.540 ± 4.8330	44.550 ± 6.7199	42.959 ± 4.8484	46.755 ± 4.8284
MCS,Week 52, n=9,5,5,5,4	44.810 ± 6.4757	45.008 ± 2.2373	42.004 ± 5.5695	42.258 ± 4.1002	42.125 ± 1.9020

No statistical analyses for this end point

Secondary: Part A: Mean EuroQol – 5 dimensions, 5 levels (EQ-5D-5L) Index score over time

Top of page

End point title

Part A: Mean EuroQol – 5 dimensions, 5 levels (EQ-5D-5L) Index score over time

End point description

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant’s health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score).

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 12, 24, 36, 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline, n=42,38,25,23,27	0.7918 ± 0.20589	0.6681 ± 0.31299	0.6912 ± 0.19348	0.7429 ± 0.22387	0.7554 ± 0.16610
Week 12, n=31,28,24,22,22	0.7866 ± 0.22042	0.7024 ± 0.22087	0.7452 ± 0.17942	0.7228 ± 0.16993	0.7069 ± 0.22289
Week 24, n=23,20,15,17,16	0.7485 ± 0.20310	0.7217 ± 0.21397	0.7135 ± 0.24006	0.7323 ± 0.10346	0.7301 ± 0.11498
Week 36, n=15,13,10,12,13	0.8011 ± 0.13468	0.7454 ± 0.22373	0.7774 ± 0.11809	0.6950 ± 0.15242	0.7506 ± 0.17536
Week 52, n=9,5,5,5,4	0.8210 ± 0.13502	0.7628 ± 0.15352	0.8092 ± 0.04275	0.7864 ± 0.05892	0.8068 ± 0.06050

No statistical analyses for this end point

Secondary: Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) over time

Top of page

End point title

Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) over time

End point description

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant’s health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent’s self-rated health on a vertical line, VAS where the endpoints are ‘Best imaginable health state’ and ‘Worst imaginable health state’.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 12, 24, 36, 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline, n=42,38,25,23,27	67.0 ± 17.83	65.6 ± 21.43	57.0 ± 17.61	62.1 ± 23.81	65.1 ± 16.00
Week 12, n=31,28,24,22,22	74.3 ± 19.77	64.2 ± 22.89	68.4 ± 19.39	63.3 ± 22.61	65.5 ± 21.33
Week 24, n=23,20,15,17,16	74.6 ± 16.26	70.6 ± 24.05	65.1 ± 23.11	64.9 ± 19.03	61.5 ± 19.71
Week 36, n=15,13,10,12,13	79.5 ± 9.55	73.9 ± 24.55	66.9 ± 20.72	68.3 ± 18.66	61.6 ± 21.29
Week 52, n=9,5,5,5,4	79.9 ± 9.74	80.6 ± 16.50	78.4 ± 14.77	60.2 ± 26.33	70.0 ± 27.41

No statistical analyses for this end point

Secondary: Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) scores over time

Top of page

End point title

Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) scores over time

End point description

The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 12, 24, 36, 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline, n=42,38,25,23,27	38.7 ± 10.72	34.2 ± 12.25	31.1 ± 9.89	38.0 ± 8.37	34.1 ± 13.32
Week 12, n=31,28,24,22,22	40.2 ± 8.83	32.7 ± 11.25	34.3 ± 11.12	38.5 ± 9.82	35.5 ± 13.34
Week 24, n=23,20,15,17,16	38.1 ± 10.48	36.5 ± 13.22	31.2 ± 13.09	36.2 ± 6.15	36.0 ± 9.18
Week 36, n=15,13,10,12,13	41.4 ± 9.41	38.4 ± 9.95	36.9 ± 10.88	40.9 ± 6.49	37.5 ± 10.02
Week 52, n=9,5,5,5,4	42.1 ± 6.72	43.0 ± 6.48	40.4 ± 5.22	44.0 ± 5.48	41.0 ± 12.25

No statistical analyses for this end point

Secondary: Part A: Mean Pain Numeric Rating Scale (NRS) scores over time

Top of page

End point title

Part A: Mean Pain Numeric Rating Scale (NRS) scores over time

End point description

The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, “no pain” to 10, “the worst pain imaginable”. Data for NRS scores over time for part A is reported.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline, n=42,38,25,23,27	1.8 ± 2.31	2.5 ± 2.97	3.1 ± 2.27	2.6 ± 2.09	2.6 ± 2.39
Week 2, n=38,38,25,21,27	1.3 ± 1.55	2.8 ± 3.08	2.8 ± 1.96	2.6 ± 2.13	2.6 ± 2.63
Week 4, n=36,37,24,22,27	1.7 ± 2.16	3.1 ± 3.13	3.3 ± 2.20	2.4 ± 2.28	1.8 ± 1.72
Week 8, n=34,30,24,21,23	1.8 ± 2.42	2.9 ± 2.73	3.0 ± 2.54	2.1 ± 1.96	3.3 ± 2.82
Week 12, n=31,28,24,22,22	1.7 ± 2.30	3.6 ± 3.05	3.3 ± 2.42	2.3 ± 2.50	2.0 ± 2.08
Week 16, n=27,25,22,19,19	1.4 ± 2.22	3.3 ± 2.84	3.0 ± 2.60	2.4 ± 2.06	2.7 ± 2.16
Week 20, n=26,23,19,18,15	1.7 ± 2.27	2.9 ± 2.70	3.6 ± 2.63	1.4 ± 1.54	2.7 ± 2.02
Week 24, n=23,20,15,17,16	2.4 ± 2.82	2.5 ± 2.42	3.3 ± 2.94	2.4 ± 1.84	3.5 ± 2.22
Week 28, n=18,17,11,13,14	2.6 ± 2.38	2.8 ± 3.03	3.6 ± 2.87	2.3 ± 2.14	2.9 ± 2.40
Week 32, n=19,14,9,12,12	2.1 ± 2.57	1.9 ± 2.67	2.9 ± 1.90	2.6 ± 2.15	3.1 ± 2.35
Week 36, n=15,13,10,12,13	1.6 ± 1.88	2.0 ± 2.55	2.9 ± 2.02	2.3 ± 2.42	1.9 ± 1.93
Week 40, n=15,11,9,10,10	2.0 ± 2.54	2.0 ± 2.57	3.1 ± 2.09	1.9 ± 1.91	2.6 ± 2.07
Week 44, n=11,11,6,8,8	2.1 ± 2.74	1.9 ± 2.47	2.2 ± 1.72	1.3 ± 0.71	3.0 ± 2.39
Week 48, n=9,8,5,7,5	1.9 ± 2.42	0.8 ± 1.04	2.6 ± 0.89	1.6 ± 1.27	4.0 ± 3.74
Week 52, n=9,5,5,5,4	1.3 ± 1.66	0.8 ± 0.84	2.8 ± 2.28	2.2 ± 0.84	1.0 ± 0.82

No statistical analyses for this end point

Secondary: Part A: Mean Health Assessment Questionnaire – Disability Index (HAQDI) Score over Time

Top of page

End point title

Part A: Mean Health Assessment Questionnaire – Disability Index (HAQDI) Score over Time

End point description

The HAQ-DI indicates the extent of the participant's functional ability during the past week, and was assessed for the subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). The HAQ-DI included 20 questions in 8 categories of functioning – dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 to 3, representing “no difficulty” (0), “some difficulty” (1), “much difficulty” (2), and “unable to do” (3) where higher scores indicating worse disability. The score for each of the 8 category scores is taken as the maximum score given to the related questions. If no questions within a given functional area were answered, no score was provided for that category.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 12, 24, 36 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline, n=19,14,13,9,12	0.6776 ± 0.65658	1.1250 ± 0.75479	0.9615 ± 0.84376	0.8889 ± 0.80875	0.8646 ± 0.62034
Week 12, n=12,8,12,9,9	0.3229 ± 0.41785	1.0938 ± 0.91063	0.7292 ± 0.87392	0.5694 ± 0.54526	0.9306 ± 0.66764
Week 24, n=10, 7,7,7,9	0.5875 ± 0.58940	0.8750 ± 0.78395	0.9821 ± 0.92823	0.9107 ± 0.83452	0.9583 ± 0.70986
Week 36, n=6,5,4,4,7	0.5208 ± 0.70007	0.8250 ± 0.80816	0.6250 ± 0.51031	0.5625 ± 0.58184	1.0000 ± 0.91287
Week 52, n=5,2,3,1,2	0.3000 ± 0.41079	0.3125 ± 0.44194	0.1667 ± 0.14434	0.0000 ± 99999	0.1875 ± 0.26517

No statistical analyses for this end point

Secondary: Part A: Number of participants with Patient Global Impression of Change (PGIC) Score over time

Top of page

End point title

Part A: Number of participants with Patient Global Impression of Change (PGIC) Score over time

End point description

Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual’s response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.

End point type

Secondary

End point timeframe

Weeks 12, 24 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Participants
Week 12,Much Better, n=31,28,24,22,22	11	7	2	5	5
Week 12,Better, n=31,28,24,22,22	11	10	11	4	11
Week 12, Slightly Better, n=31,28,24,22,22	3	5	4	8	3
Week 12,No Change, n=31,28,24,22,22	3	3	4	0	3
Week 12,Slightly Worse, n=31,28,24,22,22	1	1	2	4	0
Week 12,Worse, n=31,28,24,22,22	2	2	1	1	0
Week 12,Much Worse, n=31,28,24,22,22	0	0	0	0	0
Week 24,Much Better, n=23,20,15,17,16	11	6	6	5	6
Week 24,Better, n=23,20,15,17,16	7	8	4	6	6
Week 24, Slightly Better,n=23,20,15,17,16	2	2	0	4	1
Week 24,No Change, n=23,20,15,17,16	1	2	2	1	1
Week 24,Slightly Worse, n=23,20,15,17,16	2	1	2	1	1
Week 24, Worse,n=23,20,15,17,16	0	1	1	0	1
Week 24, Much Worse,n=23,20,15,17,16	0	0	0	0	0
Week 52,Much Better, n=9,5,5,5,4	6	3	3	2	3
Week 52,Better, n=9,5,5,5,4	2	2	1	2	0
Week 52,Slightly Better, n=9,5,5,5,4	0	0	1	1	1
Week 52,No Change, n=9,5,5,5,4	1	0	0	0	0
Week 52,Slightly Worse, n=9,5,5,5,4	0	0	0	0	0
Week 52,Worse, n=9,5,5,5,4	0	0	0	0	0
Week 52,Much Worse, n=9,5,5,5,4	0	0	0	0	0

No statistical analyses for this end point

Secondary: Part A: Mean Patient Global Assessment of disease activity (PtGA) score over time

Top of page

End point title

Part A: Mean Patient Global Assessment of disease activity (PtGA) score over time

End point description

The Patient’s Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 (“very well) to 10 (“very poor”).

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline, n=42,39,25,26,27	2.96 ± 2.148	3.72 ± 2.649	4.24 ± 2.049	3.60 ± 2.133	3.64 ± 2.732
Week 2, n=38,38,25,21,27	2.59 ± 1.923	3.51 ± 2.389	3.73 ± 1.911	3.45 ± 2.247	3.52 ± 2.177
Week 4, n=36,37,24,22,27	2.43 ± 2.138	3.75 ± 2.770	3.81 ± 1.737	3.01 ± 1.997	2.62 ± 1.762
Week 8, n=34,30,24,21,23	1.97 ± 2.076	3.87 ± 2.322	3.44 ± 1.763	2.85 ± 1.769	2.90 ± 2.230
Week 12, n=31,28,24,22,22	1.97 ± 1.567	3.80 ± 2.557	3.95 ± 2.200	3.20 ± 2.340	2.75 ± 2.056
Week 16, n=27,25,22,19,19	1.95 ± 2.237	3.82 ± 2.615	3.39 ± 2.523	2.86 ± 1.809	2.76 ± 1.777
Week 20, n=26,23,19,18,15	2.60 ± 2.089	3.20 ± 2.663	4.17 ± 2.334	2.45 ± 1.697	2.90 ± 1.869
Week 24, n=23,20,15,17,16	2.63 ± 2.140	2.33 ± 1.975	3.83 ± 2.447	2.85 ± 2.256	3.34 ± 1.791
Week 28, n=18,17,11,13,14	2.44 ± 2.094	3.09 ± 2.915	4.18 ± 2.169	2.68 ± 2.106	2.74 ± 1.791
Week 32, n=19,14,9,12,12	2.01 ± 1.781	2.22 ± 2.564	3.02 ± 1.199	2.43 ± 2.385	2.88 ± 2.541
Week 36, n=15,13,10,12,13	1.46 ± 1.253	2.66 ± 2.982	2.79 ± 2.013	2.68 ± 2.490	2.62 ± 1.990
Week 40, n=15,11,9,10,10	2.05 ± 1.809	2.35 ± 2.495	3.20 ± 2.329	2.24 ± 1.883	3.00 ± 2.658
Week 44, n=11,11,6,8,8	2.28 ± 2.872	2.19 ± 2.429	2.17 ± 1.824	2.18 ± 1.835	3.49 ± 2.322
Week 48, n=9,8,5,7,5	1.81 ± 1.934	1.03 ± 1.253	2.30 ± 1.515	1.86 ± 1.586	4.48 ± 3.545
Week 52, n=9,5,5,5,4	1.10 ± 0.857	0.46 ± 0.358	2.76 ± 2.668	2.44 ± 1.716	2.13 ± 2.651

No statistical analyses for this end point

Secondary: Part A: Mean Physician Global Assessment of disease activity (PhGA) score over time

Top of page

End point title

Part A: Mean Physician Global Assessment of disease activity (PhGA) score over time

End point description

The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 (“none”) to 10 (“extremely active”).

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Scores on scale
arithmetic mean (standard deviation)
Baseline, n=42,39,25,26,27	2.33 ± 2.101	2.95 ± 2.208	2.94 ± 2.374	3.05 ± 2.501	3.25 ± 2.823
Week 2, n=36,35,25,20,26	1.09 ± 1.373	1.52 ± 1.822	1.83 ± 1.558	1.85 ± 1.879	1.76 ± 2.094
Week 4, n=33,32,23,21,25	0.81 ± 1.191	1.44 ± 1.904	1.55 ± 1.236	0.92 ± 1.125	1.02 ± 1.090
Week 8, n=33,28,23,20,21	1.09 ± 1.508	1.30 ± 1.723	1.35 ± 1.229	0.79 ± 0.798	1.14 ± 1.226
Week 12, n=29,25,23,18,21	1.08 ± 1.486	1.81 ± 2.183	1.64 ± 1.908	1.28 ± 1.629	1.47 ± 2.151
Week 16, n=26,23,21,16,19	0.74 ± 0.895	1.54 ± 1.793	1.87 ± 2.078	1.39 ± 1.830	0.67 ± 0.779
Week 20, n=25,23,18,17,15	0.71 ± 1.189	1.42 ± 1.808	1.16 ± 1.628	0.83 ± 0.882	1.27 ± 1.622
Week 24, n=20,20,15,15,15	0.82 ± 1.089	0.68 ± 0.869	1.50 ± 1.690	1.48 ± 2.003	1.37 ± 1.551
Week 28, n=17,17,11,12,13	0.76 ± 1.068	1.43 ± 1.986	1.18 ± 2.116	0.88 ± 0.586	0.85 ± 1.440
Week 32, n=19,14,8,11,12	0.83 ± 1.320	0.67 ± 0.841	1.40 ± 1.516	1.26 ± 1.546	0.89 ± 1.672
Week 36, n=13,11,10,11,13	0.48 ± 0.660	1.12 ± 1.589	0.61 ± 0.792	0.56 ± 0.408	0.75 ± 0.906
Week 40, n=13,9,8,9,10	0.38 ± 0.395	0.77 ± 1.417	0.36 ± 0.283	0.52 ± 0.531	0.57 ± 0.566
Week 44, n=10,9,6,8,7	0.31 ± 0.228	1.07 ± 1.574	0.43 ± 0.547	0.58 ± 0.740	0.87 ± 1.404
Week 48, n=7,7,5,6,5	0.27 ± 0.446	0.31 ± 0.540	0.30 ± 0.316	0.78 ± 1.482	1.60 ± 2.164
Week 52, n=9,5,5,4,4	0.31 ± 0.434	0.10 ± 0.141	0.32 ± 0.311	1.35 ± 0.947	1.80 ± 3.082

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in serum C Reactive Protein (CRP) over time

Top of page

End point title

Part A: Change from Baseline in serum C Reactive Protein (CRP) over time

End point description

Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Milligrams per liter
arithmetic mean (standard deviation)
Week 2,n=38,39,26,24,26	-5.07 ± 6.616	-8.81 ± 22.954	-5.15 ± 8.436	1.27 ± 13.155	1.07 ± 6.794
Week 4,n=37,38,25,23,27	-4.39 ± 6.384	-9.01 ± 23.327	-4.09 ± 7.169	4.91 ± 10.503	0.76 ± 5.511
Week 8,n=34,31,24,22,23	-4.98 ± 6.583	-9.94 ± 25.685	-4.19 ± 7.197	10.00 ± 14.652	7.86 ± 25.894
Week 12,n=32,28,24,21,21	-5.08 ± 6.690	-9.96 ± 26.849	-4.22 ± 7.335	14.81 ± 18.082	4.04 ± 9.339
Week 16,n=28,26,22,19,18	-4.35 ± 5.648	-10.43 ± 27.765	-4.48 ± 7.621	10.53 ± 17.303	6.99 ± 15.503
Week 20,n=26,23,19,18,16	-4.50 ± 5.876	-11.67 ± 29.422	-4.78 ± 8.100	5.32 ± 14.506	2.35 ± 7.840
Week 24,n=23,20,16,17,16	-4.38 ± 4.640	-13.19 ± 31.269	-5.14 ± 8.837	5.07 ± 13.815	6.54 ± 20.711
Week 28,n=19,18,12,14,14	-5.28 ± 6.498	-13.42 ± 33.182	-6.33 ± 10.022	1.87 ± 10.926	0.22 ± 11.318
Week 32,n=19,15,10,12,13	-4.85 ± 7.259	-14.47 ± 36.343	-7.15 ± 10.875	2.61 ± 9.835	4.37 ± 16.277
Week 36,n=15,12,10,12,13	-4.72 ± 4.473	-16.28 ± 40.531	-7.08 ± 10.874	5.73 ± 19.040	1.64 ± 10.418
Week 40,n=15,11,8,10,10	-4.72 ± 4.374	-17.67 ± 42.240	-4.69 ± 8.510	6.27 ± 21.164	2.77 ± 13.101
Week 44,n=11,11,6,8,9	-5.35 ± 4.523	-17.47 ± 42.350	-1.90 ± 1.456	2.80 ± 20.439	5.13 ± 7.292
Week 48,n=9,7,5,8,5	-5.91 ± 4.993	-23.39 ± 52.962	-2.20 ± 1.562	6.31 ± 20.952	8.10 ± 18.084
Week 52,n=9,5,5,5,4	-6.00 ± 4.663	-7.26 ± 9.461	-2.20 ± 1.575	0.64 ± 9.453	-1.65 ± 4.561

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) over time

Top of page

End point title

Part A: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) over time

End point description

Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Millimeters per hour
arithmetic mean (standard deviation)
Week 2,n=37,39,26,24,26	-13.05 ± 9.885	-12.78 ± 15.560	-14.62 ± 16.500	-1.33 ± 9.323	-9.96 ± 20.142
Week 4,n=36,38,25,22,27	-12.83 ± 9.346	-17.41 ± 15.867	-14.13 ± 12.419	7.59 ± 15.308	-5.30 ± 22.250
Week 8,n=33,31,24,22,23	-14.21 ± 9.927	-18.76 ± 17.727	-15.05 ± 14.030	6.41 ± 12.105	1.78 ± 27.361
Week 12,n=32,28,24,22,22	-14.97 ± 11.361	-17.89 ± 17.846	-14.30 ± 13.271	20.36 ± 18.017	-2.55 ± 21.498
Week 16,n=28,26,22,19,19	-12.50 ± 10.469	-17.17 ± 17.693	-15.37 ± 13.956	14.21 ± 25.189	-2.53 ± 20.839
Week 20,n=26,23,18,18,16	-13.19 ± 9.600	-17.07 ± 18.498	-14.33 ± 15.442	10.00 ± 22.141	-5.81 ± 23.063
Week 24,n=23,19,16,17,16	-13.63 ± 11.209	-16.84 ± 15.378	-14.89 ± 14.504	7.59 ± 21.567	-3.06 ± 22.389
Week 28,n=19,18,11,14,14	-15.26 ± 12.274	-19.94 ± 20.069	-16.84 ± 16.856	1.50 ± 15.854	-1.71 ± 29.148
Week 32,n=19,15,10,12,13	-13.26 ± 17.486	-19.80 ± 19.266	-14.52 ± 13.630	-2.42 ± 20.129	-2.85 ± 29.493
Week 36,n=15,12,10,12, 13	-14.47 ± 11.673	-21.25 ± 20.855	-14.42 ± 13.482	0.67 ± 19.009	0.92 ± 28.324
Week 40,n=15,11,9,10,10	-14.40 ± 12.070	-22.27 ± 21.873	-11.24 ± 13.277	9.80 ± 28.840	-2.60 ± 27.818
Week 44,n=11,11,6,8,8	-12.64 ± 10.347	-22.18 ± 21.409	-12.00 ± 13.520	4.88 ± 18.256	2.88 ± 21.860
Week 48,n=9,8,5,8,5	-15.33 ± 11.822	-25.63 ± 24.372	-14.00 ± 14.335	4.50 ± 24.308	8.60 ± 25.205
Week 52,n=9,5,5,5,4	-14.78 ± 11.692	-24.60 ± 17.700	-12.80 ± 15.385	-4.60 ± 10.431	1.25 ± 15.042

No statistical analyses for this end point

Secondary: Part A: Number of participants with adverse events (AEs), serious AEs (SAEs) and corticosteroid related AEs

Top of page

End point title

Part A: Number of participants with adverse events (AEs), serious AEs (SAEs) and corticosteroid related AEs

End point description

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.

End point type

Secondary

End point timeframe

Up to 52 weeks

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Participants
Any AE	41	36	25	26	24
Any SAE	8	6	6	5	6
Any Corticosteroid related AE	18	21	15	13	12

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Top of page

End point title

Part A: Change from Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

End point description

SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Millimeters of mercury
arithmetic mean (standard deviation)
SBP,Week 2,n=37,39,26,24,27	-0.9 ± 13.11	3.5 ± 13.97	-2.1 ± 17.19	5.7 ± 12.67	-0.9 ± 15.63
SBP,Week 4,n=37,37,25,23,27	-0.9 ± 15.17	0.2 ± 15.99	-4.7 ± 15.00	-2.2 ± 14.60	-3.4 ± 14.25
SBP,Week 8,n=34,32,24,22,23	0.3 ± 14.33	-3.9 ± 17.17	-3.5 ± 15.73	-0.8 ± 18.94	-8.3 ± 21.05
SBP,Week 12,n=32,29,24,22,22	-2.3 ± 15.19	-2.4 ± 17.15	-6.2 ± 13.45	1.4 ± 12.97	-6.1 ± 19.31
SBP,Week 16,n=28,26,22,19,19	-6.0 ± 15.39	-5.1 ± 18.28	-3.0 ± 20.22	1.9 ± 17.51	-6.4 ± 12.73
SBP,Week 20,n=26,23,19,18,16	-6.7 ± 10.73	-0.7 ± 14.09	-3.4 ± 15.39	-1.7 ± 17.16	-9.4 ± 21.44
SBP,Week 24,n=23,21,16,17,16	-5.2 ± 12.65	-2.5 ± 15.46	-5.6 ± 16.55	-2.6 ± 18.75	-8.6 ± 15.65
SBP,Week 28,n=19,18,12,14,14	-8.8 ± 12.87	-4.2 ± 20.49	-0.1 ± 14.76	6.4 ± 19.31	-2.6 ± 17.71
SBP,Week 32,n=19,15,10,12,13	-10.7 ± 13.96	-3.7 ± 15.03	-7.4 ± 11.80	3.4 ± 14.99	-8.8 ± 14.80
SBP,Week 36,n=15,13,10,12,13	-6.2 ± 13.92	-8.0 ± 15.80	-6.8 ± 12.10	-0.6 ± 20.46	-2.5 ± 16.13
SBP,Week 40,n=15,11,9,10,10	-11.9 ± 11.75	0.9 ± 13.14	-4.8 ± 14.17	2.1 ± 19.31	-7.4 ± 20.14
SBP,Week 44,n=11,11,6,8,9	-12.7 ± 17.66	-4.2 ± 19.22	2.7 ± 13.26	2.9 ± 15.99	1.8 ± 13.91
SBP,Week 48,n=9,8,5,8,5	-13.6 ± 11.85	-0.4 ± 9.44	-3.6 ± 28.13	8.8 ± 14.15	4.8 ± 15.51
SBP,Week 52,n=9,5,5,5,4	-8.1 ± 15.85	1.2 ± 14.46	2.2 ± 19.52	2.2 ± 18.46	-3.8 ± 12.34
DBP,Week 2,n=37,39,26,24,27	0.3 ± 7.41	1.2 ± 10.05	-2.3 ± 14.00	2.4 ± 9.85	-2.2 ± 9.22
DBP,Week 4,n=37,37,25,23,27	1.8 ± 8.85	1.5 ± 10.24	-4.1 ± 13.22	0.1 ± 11.66	-3.0 ± 10.22
DBP,Week 8,n=34,32,24,22,23	2.1 ± 8.47	-1.3 ± 7.62	-4.0 ± 12.26	2.6 ± 11.27	-5.6 ± 11.83
DBP,Week 12,n=32,29,24,22,22	1.0 ± 9.60	2.0 ± 12.35	-4.7 ± 12.14	1.3 ± 10.58	-2.5 ± 11.16
DBP,Week 16,n=28,26,22,19,19	0.2 ± 7.48	-2.5 ± 11.58	-3.1 ± 12.80	-1.3 ± 10.64	-3.4 ± 7.97
DBP,Week 20,n=26,23,19,18,16	-0.9 ± 7.66	1.4 ± 12.47	-3.2 ± 16.21	-2.0 ± 9.06	-2.1 ± 10.98
DBP,Week 24,n=23,21,16,17,16	1.3 ± 8.72	-0.6 ± 12.85	-2.7 ± 11.77	-3.3 ± 10.21	-3.1 ± 9.27
DBP,Week 28,n=19,18,12,14,14	-3.1 ± 9.39	-2.2 ± 10.05	-4.3 ± 15.80	0.1 ± 13.87	-1.9 ± 10.37
DBP,Week 32,n=19,15,10,12,13	-4.2 ± 7.50	-2.3 ± 12.92	-6.9 ± 25.47	-1.2 ± 11.17	-5.8 ± 9.09
DBP,Week 36,n=15,13,10,12,13	-0.6 ± 8.92	-5.1 ± 9.89	-5.6 ± 17.02	-1.2 ± 13.31	-2.7 ± 13.05
DBP,Week 40,n=15,11,9,10,10	-6.9 ± 12.41	2.6 ± 11.88	-8.0 ± 21.60	-2.0 ± 14.07	-6.1 ± 11.97
DBP,Week 44,n=11,11,6,8,9	-2.7 ± 12.10	-6.5 ± 14.56	-2.5 ± 23.89	-1.5 ± 8.28	1.3 ± 11.36
DBP,Week 48,n=9,8,5,8,5	-5.6 ± 11.79	-2.3 ± 11.42	-2.0 ± 16.00	-3.4 ± 12.75	0.6 ± 8.47
DBP,Week 52,n=9,5,5,5,4	0.2 ± 12.55	1.8 ± 10.23	2.2 ± 3.35	1.4 ± 11.89	0.5 ± 5.92

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in Pulse Rate

Top of page

End point title

Part A: Change from Baseline in Pulse Rate

End point description

Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Beats per minute
arithmetic mean (standard deviation)
Week 2, ,n=37,39,25,24,27	-1.9 ± 8.07	-2.1 ± 8.93	1.8 ± 10.40	-0.4 ± 12.34	-1.6 ± 9.79
Week 4,n=37,37,25,22,27	0.2 ± 8.82	-1.4 ± 8.94	-2.4 ± 9.42	2.2 ± 13.39	-1.9 ± 10.33
Week 8,n=34,32,24,22,23	-1.1 ± 10.23	-3.2 ± 11.42	-3.1 ± 8.80	4.3 ± 12.36	0.5 ± 11.06
Week 12,n=32,29,23,22,22	-3.8 ± 8.50	-1.2 ± 13.62	-0.8 ± 8.35	4.5 ± 14.54	-2.7 ± 10.95
Week 16,n=28,26,22,19,19	-3.4 ± 10.79	0.3 ± 9.06	-5.3 ± 10.32	0.3 ± 15.04	-2.2 ± 10.76
Week 20,n=26,23,19,18,16	-3.0 ± 9.75	0.2 ± 11.35	-0.7 ± 12.62	1.0 ± 13.76	-4.0 ± 12.54
Week 24,n=23,21,16,17,16	-2.1 ± 9.29	-3.5 ± 11.18	0.7 ± 14.13	0.1 ± 12.76	2.7 ± 8.27
Week 28,n=19,18,12,14,14	-1.4 ± 10.33	-1.2 ± 9.21	-3.5 ± 13.26	0.1 ± 13.24	0.5 ± 10.60
Week 32,n=19,15,10,12,13	-1.3 ± 8.20	-4.7 ± 8.50	-2.2 ± 10.78	-0.8 ± 16.10	-0.6 ± 12.58
Week 36,n=15,13,10,12,13	-5.9 ± 9.79	-5.1 ± 9.06	-4.5 ± 9.12	-0.5 ± 12.22	-3.2 ± 9.83
Week 40,n=15,11,9,10,10	-3.9 ± 5.64	-3.0 ± 11.93	-3.4 ± 10.57	3.3 ± 12.83	-3.8 ± 14.09
Week 44,n=11,11,6,8,9	-7.1 ± 8.01	-3.4 ± 15.86	-8.3 ± 13.41	4.3 ± 15.34	-3.4 ± 8.57
Week 48,n=9,8,5,8,5	-8.2 ± 7.36	-9.3 ± 8.76	-7.2 ± 10.47	-1.9 ± 11.47	0.0 ± 16.72
Week 52,n=9,5,5,5,4	-5.0 ± 12.97	-11.0 ± 3.74	-4.0 ± 15.89	6.8 ± 6.34	-5.3 ± 12.04

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in Temperature

Top of page

End point title

Part A: Change from Baseline in Temperature

End point description

Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month prednisone	PartA:SIR 100 mg SC q2w+3 month prednisone	PartA:SIR 50 mg SC q4w+6 month prednisone	PartA:Placebo SC q2w + 6 month prednisone	PartA:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	42	39	26	27	27
Units: Celsius
arithmetic mean (standard deviation)
Week 2, ,n=37,39,26,24,27	-0.11 ± 0.269	-0.04 ± 0.336	0.03 ± 0.433	-0.16 ± 0.421	0.10 ± 0.449
Week 4,n=37,37,25,23,27	-0.12 ± 0.345	0.01 ± 0.407	0.04 ± 0.399	-0.10 ± 0.387	0.11 ± 0.340
Week 8,n=34,32,23,22,23	-0.04 ± 0.400	-0.09 ± 0.432	-0.07 ± 0.553	0.04 ± 0.579	0.19 ± 0.425
Week 12,n=32,29,24,22,22	-0.08 ± 0.461	-0.11 ± 0.367	0.01 ± 0.444	-0.15 ± 0.494	0.09 ± 0.450
Week 16,n=28,26,22,19,19	-0.08 ± 0.313	-0.05 ± 0.392	0.04 ± 0.316	-0.21 ± 0.664	0.09 ± 0.317
Week 20,n=26,23,19,18,16	0.03 ± 0.428	-0.05 ± 0.483	-0.12 ± 0.651	-0.07 ± 0.355	0.05 ± 0.395
Week 24,n=23,21,16,17,16	0.03 ± 0.389	-0.11 ± 0.255	-0.11 ± 0.558	-0.26 ± 0.476	0.04 ± 0.441
Week 28,n=19,18,12,13,14	0.03 ± 0.444	-0.07 ± 0.517	-0.09 ± 0.683	-0.16 ± 0.479	-0.06 ± 0.282
Week 32,n=19,15,10,12,13	-0.01 ± 0.515	-0.07 ± 0.349	0.28 ± 0.418	-0.13 ± 0.367	0.01 ± 0.364
Week 36,n=15,13,9,12,13	-0.09 ± 0.406	-0.11 ± 0.569	-0.10 ± 0.391	-0.09 ± 0.390	-0.08 ± 0.367
Week 40,n=15,11,9,10,10	0.08 ± 0.426	-0.03 ± 0.454	0.18 ± 0.438	-0.05 ± 0.334	-0.05 ± 0.306
Week 44,n=11,11,6,8,9	-0.14 ± 0.347	-0.06 ± 0.391	-0.03 ± 0.314	0.00 ± 0.438	-0.08 ± 0.396
Week 48,n=9,8,5,8,5	-0.22 ± 0.233	-0.05 ± 0.510	-0.14 ± 0.498	-0.01 ± 0.280	-0.08 ± 0.559
Week 52,n=9,5,5,5,4	-0.08 ± 0.291	-0.32 ± 0.286	0.14 ± 0.230	0.02 ± 0.409	-0.08 ± 0.814

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets

Top of page

End point title

Part A: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets

End point description

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Giga cells per liter
arithmetic mean (standard deviation)
Eosinophils,Week 2,n=37,36,24,23,25	0.019 ± 0.0543	0.001 ± 0.0690	0.010 ± 0.0433	0.015 ± 0.0557	0.062 ± 0.2084
Eosinophils,Week 4,n=36,37,24,22,26	0.043 ± 0.0934	0.035 ± 0.1238	0.012 ± 0.0719	0.023 ± 0.0617	0.030 ± 0.1164
Eosinophils,Week 8,n=34,29,22,22,21	0.056 ± 0.0959	0.102 ± 0.1634	0.054 ± 0.1036	0.048 ± 0.1498	0.010 ± 0.0591
Eosinophils,Week 12,n=31,28,23,22,22	0.077 ± 0.1128	0.155 ± 0.1971	0.090 ± 0.0860	0.090 ± 0.1684	0.030 ± 0.0548
Eosinophils,Week 16,n=27,26,20,19,19	0.097 ± 0.1307	0.162 ± 0.2170	0.117 ± 0.1772	0.067 ± 0.1148	0.067 ± 0.1746
Eosinophils,Week 20,n=25,22,18,17,16	0.166 ± 0.2073	0.114 ± 0.2085	0.136 ± 0.1518	0.094 ± 0.1743	0.057 ± 0.0637
Eosinophils,Week 24,n=22,21,16,16,16	0.210 ± 0.4418	0.109 ± 0.1590	0.109 ± 0.1094	0.089 ± 0.2392	0.051 ± 0.0676
Eosinophils,Week 28,n=18,18,11,14,13	0.163 ± 0.2562	0.068 ± 0.1340	0.120 ± 0.1340	0.046 ± 0.0714	0.051 ± 0.0538
Eosinophils,Week 32,n=19,15,10,12,13	0.244 ± 0.3707	0.069 ± 0.1580	0.092 ± 0.1253	0.038 ± 0.0597	0.056 ± 0.0733
Eosinophils,Week 36,n=15,12,10,12,12	0.282 ± 0.3117	0.076 ± 0.1753	0.153 ± 0.1166	0.049 ± 0.0720	0.059 ± 0.0585
Eosinophils,Week 40,n=14,11,8,10,10	0.191 ± 0.2175	0.075 ± 0.1924	0.104 ± 0.1161	0.065 ± 0.0737	0.071 ± 0.1140
Eosinophils,Week 44,n=11,10,6,7,9	0.144 ± 0.1952	0.045 ± 0.1329	0.165 ± 0.1564	0.024 ± 0.0541	0.066 ± 0.0600
Eosinophils,Week 48,n=9,8,4,8,5	0.091 ± 0.0664	0.059 ± 0.1561	0.233 ± 0.2387	0.028 ± 0.0489	0.030 ± 0.0604
Eosinophils,Week 52,n=8,5,5,5,4	0.151 ± 0.1865	0.192 ± 0.1839	0.172 ± 0.1207	0.108 ± 0.1139	0.013 ± 0.0802
Leukocytes,Week 2,n=37,38,24,24,25	-3.12 ± 2.268	-3.63 ± 1.971	-3.32 ± 2.816	-0.76 ± 2.145	0.34 ± 2.238
Leukocytes,Week 4,n=36,37,24,22,26	-3.66 ± 2.621	-4.76 ± 2.411	-4.07 ± 2.157	-1.64 ± 2.247	-0.16 ± 2.330
Leukocytes,Week 8,n=34,29,23,22,21	-4.04 ± 2.481	-5.65 ± 3.672	-4.42 ± 2.469	-1.79 ± 2.682	-0.26 ± 1.880
Leukocytes,Week 12,n=31,28,23,22,22	-4.68 ± 2.666	-5.67 ± 2.551	-5.23 ± 2.581	-2.66 ± 2.883	-1.28 ± 1.810
Leukocytes,Week 16,n=27,26,20,19,19	-5.21 ± 2.244	-5.61 ± 3.502	-5.36 ± 2.309	-2.98 ± 3.018	-0.79 ± 3.018
Leukocytes,Week 20,n=25,23,18,18,16	-5.24 ± 1.950	-5.20 ± 3.104	-5.40 ± 2.414	-3.24 ± 3.592	-1.71 ± 2.840
Leukocytes,Week 24,n=22,21,16,16,16	-5.14 ± 3.559	-6.39 ± 2.952	-5.01 ± 1.884	-2.89 ± 3.892	-1.52 ± 2.738
Leukocytes,Week 28,n=18,18,12,14,13	-5.46 ± 2.619	-6.04 ± 3.274	-4.58 ± 2.143	-3.01 ± 3.368	-1.97 ± 3.461
Leukocytes,Week 32,n=19,15,10,12,13	-5.71 ± 2.419	-5.61 ± 3.250	-5.27 ± 1.696	-3.43 ± 3.342	-2.33 ± 3.011
Leukocytes,Week 36,n=15,12,10,12,12	-5.76 ± 2.106	-6.82 ± 2.814	-5.58 ± 1.757	-3.36 ± 3.612	-2.95 ± 3.635
Leukocytes,Week 40,n=14,11,8,10,10	-6.14 ± 1.987	-7.10 ± 2.534	-6.46 ± 2.130	-3.18 ± 3.662	-2.23 ± 3.142
Leukocytes,Week 44,n=11,10,6,7,9	-6.25 ± 2.300	-6.95 ± 2.441	-6.17 ± 1.726	-2.83 ± 3.875	-3.08 ± 3.056
Leukocytes,Week 48,n=9,8,4,8,5	-6.88 ± 2.436	-7.35 ± 2.853	-6.48 ± 2.887	-2.69 ± 2.979	-3.00 ± 3.045
Leukocytes,Week 52,n=8,5,5,5,4	-6.66 ± 2.654	-7.36 ± 2.920	-6.38 ± 2.262	-3.84 ± 3.467	-3.10 ± 4.090
Lymphocytes,Week 2,n=37,36,24,23,25	0.015 ± 1.1645	0.002 ± 1.2620	-0.041 ± 1.3241	-0.159 ± 0.9064	-0.209 ± 0.9381
Lymphocytes,Week 4,n=36,37,24,22,26	0.027 ± 1.2460	-0.255 ± 1.2225	0.057 ± 1.2338	-0.002 ± 0.7340	-0.382 ± 1.0808
Lymphocytes,Week 8,n=34,29,22,22,21	-0.191 ± 1.3361	-0.411 ± 1.2086	-0.067 ± 1.2814	-0.049 ± 1.0832	-0.516 ± 0.8562
Lymphocytes,Week 12,n=31,28,23,22,22	-0.215 ± 1.3052	-0.437 ± 1.2479	-0.081 ± 1.2018	-0.128 ± 1.0505	-0.344 ± 0.7846
Lymphocytes,Week 16,n=27,26,20,19,19	-0.450 ± 1.3450	-0.704 ± 1.2994	-0.153 ± 0.7804	-0.327 ± 1.4269	-0.635 ± 0.8037
Lymphocytes,Week 20,n=25,22,18,17,16	-0.616 ± 1.2793	-0.313 ± 1.3011	-0.439 ± 1.4363	-0.385 ± 0.8819	-0.533 ± 0.7432
Lymphocytes,Week 24,n=22,21,16,16,16	-0.399 ± 1.4276	-0.179 ± 1.8386	-0.073 ± 0.7890	-0.401 ± 1.2030	-0.386 ± 0.7504
Lymphocytes,Week 28,n=18,18,11,14,13	-0.614 ± 1.5450	-0.273 ± 1.3296	-0.192 ± 0.7271	-0.258 ± 1.0211	-0.565 ± 1.0397
Lymphocytes,Week 32,n=19,15,10,12,13	-0.602 ± 1.3438	-0.407 ± 1.4002	-0.476 ± 0.7997	-0.402 ± 1.2625	-0.492 ± 0.7877
Lymphocytes,Week 36,n=15,12,10,12,12	-0.625 ± 1.5738	-0.672 ± 1.2263	-0.430 ± 0.7690	-0.417 ± 1.0538	-0.078 ± 0.7182
Lymphocytes,Week 40,n=14,11,8,10,10	-0.929 ± 1.5351	-0.845 ± 1.3603	-0.570 ± 0.8261	-0.519 ± 1.1491	-0.681 ± 0.7363
Lymphocytes,Week 44,n=11,10,6,7,9	-0.915 ± 1.2235	-1.047 ± 1.3375	-0.198 ± 0.9783	-1.029 ± 1.0293	-0.343 ± 0.8113
Lymphocytes,Week 48,n=9,8,4,8,5	-1.258 ± 1.2063	-0.923 ± 1.4811	0.118 ± 1.0588	-0.576 ± 1.1994	-0.510 ± 1.1450
Lymphocytes,Week 52,n=8,5,5,5,4	-1.253 ± 1.2857	-0.754 ± 1.0291	-0.286 ± 1.0455	0.194 ± 0.8800	-0.128 ± 1.2618
Neutrophils,Week 2,n=37,36,24,23,25	-3.208 ± 2.5761	-3.454 ± 2.2265	-3.367 ± 2.5781	-0.748 ± 2.2688	0.387 ± 2.6156
Neutrophils,Week 4,n=36,37,24,22,26	-3.791 ± 2.5242	-4.476 ± 2.3632	-4.106 ± 2.4354	-1.673 ± 1.9745	0.089 ± 3.1611
Neutrophils,Week 8,n=34,29,22,22,21	-3.949 ± 2.5477	-5.271 ± 3.2214	-4.354 ± 2.4128	-1.869 ± 3.2525	0.192 ± 2.2180
Neutrophils,Week 12,n=31,28,23,22,22	-4.590 ± 2.6603	-5.340 ± 2.6437	-5.250 ± 2.1872	-2.678 ± 3.1106	-1.019 ± 2.1306
Neutrophils,Week 16,n=27,26,20,19,19	-4.933 ± 2.4430	-4.929 ± 3.7907	-5.358 ± 2.2367	-2.766 ± 3.3212	-0.263 ± 3.3610
Neutrophils,Week 20,n=25,22,18,17,16	-4.867 ± 2.3110	-4.997 ± 3.0763	-5.168 ± 2.4898	-2.856 ± 4.0311	-1.355 ± 3.3883
Neutrophils,Week 24,n=22,21,16,16,16	-4.985 ± 3.5051	-6.257 ± 2.7551	-5.030 ± 1.9579	-2.570 ± 4.2089	-1.342 ± 3.1038
Neutrophils,Week 28,n=18,18,11,14,13	-5.076 ± 2.3415	-5.729 ± 3.1699	-4.469 ± 2.1333	-2.764 ± 3.5787	-1.503 ± 4.3502
Neutrophils,Week 32,n=19,15,10,12,13	-5.357 ± 2.5525	-5.153 ± 3.1939	-4.840 ± 1.9387	-3.006 ± 3.7915	-2.018 ± 3.5674
Neutrophils,Week 36,n=15,12,10,12,12	-5.444 ± 2.1894	-6.079 ± 3.0406	-5.265 ± 1.8375	-3.023 ± 3.9443	-3.018 ± 4.1223
Neutrophils,Week 40,n=14,11,8,10,10	-5.416 ± 2.4371	-6.179 ± 2.8859	-5.916 ± 1.7172	-2.705 ± 3.4469	-1.663 ± 3.4090
Neutrophils,Week 44,n=11,10,6,7,9	-5.432 ± 2.5555	-5.799 ± 3.1785	-6.185 ± 1.3944	-1.807 ± 4.5472	-2.883 ± 3.8690
Neutrophils,Week 48,n=9,8,4,8,5	-5.628 ± 2.3471	-6.396 ± 3.4832	-6.790 ± 1.6060	-2.160 ± 3.3843	-2.650 ± 4.0017
Neutrophils,Week 52,n=8,5,5,5,4	-5.520 ± 2.7316	-6.774 ± 2.6817	-6.256 ± 1.8929	-4.214 ± 3.6948	-2.990 ± 4.8629
Platelets,Week 2,n=37,38,24,23,25	-39.0 ± 39.46	-49.2 ± 52.77	-41.1 ± 40.29	-1.9 ± 37.57	-4.3 ± 49.32
Platelets,Week 4,n=36,37,24,22,26	-45.9 ± 41.70	-64.3 ± 56.21	-49.0 ± 35.74	2.1 ± 41.23	-5.7 ± 43.51
Platelets,Week 8,n=34,29,22,22,21	-37.3 ± 31.22	-72.2 ± 75.77	-53.3 ± 37.10	14.2 ± 45.62	15.7 ± 57.21
Platelets,Week 12,n=31,28,23,22,22	-51.2 ± 33.25	-74.0 ± 52.17	-55.4 ± 38.89	17.8 ± 50.58	4.3 ± 55.14
Platelets,Week 16,n=27,26,20,19,19	-53.8 ± 33.54	-69.9 ± 53.79	-54.8 ± 39.71	12.4 ± 52.98	13.8 ± 60.11
Platelets,Week 20,n=25,22,18,17,16	-52.2 ± 54.64	-69.5 ± 58.27	-53.5 ± 38.00	14.8 ± 44.55	-0.1 ± 56.21
Platelets,Week 24,n=22,21,16,16,16	-58.0 ± 39.58	-72.4 ± 64.56	-57.5 ± 44.46	6.3 ± 46.94	20.1 ± 45.30
Platelets,Week 28,n=18,18,11,14,13	-70.2 ± 45.09	-61.3 ± 54.34	-50.6 ± 27.71	15.4 ± 31.84	13.1 ± 47.56
Platelets,Week 32,n=19,15,10,12,13	-57.6 ± 66.52	-65.5 ± 51.20	-50.8 ± 33.70	-1.5 ± 45.26	10.7 ± 53.95
Platelets,Week 36,n=15,12,10,12,12	-74.1 ± 32.84	-70.6 ± 58.49	-48.6 ± 23.64	13.4 ± 32.69	20.0 ± 85.28
Platelets,Week 40,n=14,11,8,10,10	-77.4 ± 41.72	-66.9 ± 62.21	-42.0 ± 21.33	5.6 ± 45.38	5.3 ± 54.71
Platelets,Week 44,n=11,10,6,7,9	-69.5 ± 36.62	-76.7 ± 64.91	-58.2 ± 19.28	11.1 ± 48.18	-3.3 ± 56.78
Platelets,Week 48,n=9,8,4,8,5	-68.3 ± 41.94	-71.4 ± 57.71	-80.8 ± 22.98	14.4 ± 53.59	0.4 ± 61.59
Platelets,Week 52,n=8,5,5,5,4	-81.9 ± 38.36	-51.6 ± 43.90	-58.6 ± 40.79	-18.6 ± 55.44	-17.5 ± 38.04

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in hematology parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin

Top of page

End point title

Part A: Change from Baseline in hematology parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin

End point description

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Grams per liter
arithmetic mean (standard deviation)
MCHC,Week 2,n=32,33,18,22,23	-0.5 ± 6.21	0.1 ± 9.47	1.9 ± 5.11	-1.1 ± 6.56	1.2 ± 8.41
MCHC,Week 4,n=31,31,19,20,25	1.6 ± 7.36	2.3 ± 11.94	2.6 ± 9.46	0.1 ± 5.17	2.4 ± 9.32
MCHC,Week 8,n=28,24,18,20,20	6.1 ± 8.97	6.7 ± 10.98	6.4 ± 9.09	0.6 ± 9.53	6.7 ± 8.19
MCHC,Week 12,n=25,23,18,20,20	6.5 ± 9.77	6.7 ± 9.03	5.9 ± 14.20	1.3 ± 9.55	4.9 ± 7.81
MCHC,Week 16,n=22,21,17,17,17	8.3 ± 9.80	8.9 ± 12.41	10.2 ± 8.50	0.9 ± 11.52	4.5 ± 9.62
MCHC,Week 20,n=19,18,14,16,14	7.7 ± 8.43	10.8 ± 9.53	9.0 ± 8.60	3.4 ± 10.38	4.6 ± 12.48
MCHC,Week 24,n=16,16,13,15,14	4.7 ± 7.50	14.6 ± 11.04	4.9 ± 9.97	3.0 ± 7.46	4.9 ± 11.49
MCHC,Week 28,n=13,14,10,12,11	4.5 ± 7.78	9.2 ± 11.52	8.9 ± 11.41	2.8 ± 13.57	-0.4 ± 7.86
MCHC,Week 32,n=13,11,8,10,11	6.9 ± 9.33	8.4 ± 10.45	8.8 ± 9.05	6.7 ± 8.88	1.4 ± 8.58
MCHC,Week 36,n=10,10,8,10,10	6.9 ± 5.11	6.7 ± 9.72	13.5 ± 8.07	7.9 ± 11.44	4.2 ± 5.90
MCHC,Week 40,n=10,9,7,8,9	11.5 ± 9.89	11.3 ± 7.75	14.4 ± 12.45	5.1 ± 15.30	13.9 ± 12.39
MCHC,Week 44,n=8,8,4,5,8	12.5 ± 7.17	9.9 ± 9.86	13.5 ± 4.12	5.2 ± 4.60	12.1 ± 10.99
MCHC,Week 48,n=6,7,2,6,4	13.3 ± 9.07	11.9 ± 9.84	10.5 ± 13.44	3.8 ± 11.48	9.3 ± 9.32
MCHC,Week 52,n=6,4,3,4,3	16.5 ± 5.47	18.8 ± 5.68	24.0 ± 3.46	11.3 ± 5.06	5.0 ± 9.85
Hemoglobin,Week 2,n=38,39,24,24,25	1.2 ± 6.50	2.5 ± 6.85	1.3 ± 8.72	-2.4 ± 7.08	-0.9 ± 5.44
Hemoglobin,Week 4,n=36,37,24,22,27	3.0 ± 6.37	2.8 ± 8.17	2.5 ± 6.55	-1.0 ± 8.45	-2.1 ± 6.86
Hemoglobin,Week 8,n=34,29,23,22,21	5.9 ± 9.57	4.7 ± 9.59	3.1 ± 7.00	-1.4 ± 10.54	-2.8 ± 7.41
Hemoglobin,Week 12,n=31,28,23,22,22	5.8 ± 7.85	8.4 ± 10.62	4.7 ± 6.24	-3.2 ± 11.11	-1.4 ± 7.10
Hemoglobin,Week 16,n=27,26,21,19,19	2.6 ± 6.00	5.8 ± 8.87	4.2 ± 7.03	-3.8 ± 10.55	-1.7 ± 7.47
Hemoglobin,Week 20,n=25,23,18,18,16	2.0 ± 7.89	7.4 ± 9.69	3.3 ± 5.58	-4.6 ± 11.32	-0.6 ± 6.22
Hemoglobin,Week 24,n=22,21,16,16,16	2.2 ± 8.67	7.0 ± 9.99	5.4 ± 6.38	-3.1 ± 12.05	-0.9 ± 6.43
Hemoglobin,Week 28,n=18,18,12,14,13	0.3 ± 9.68	5.8 ± 11.83	2.8 ± 6.92	-4.4 ± 11.45	-1.5 ± 8.88
Hemoglobin,Week 32,n=19,15,10,12,13	0.9 ± 9.04	5.1 ± 10.88	2.0 ± 9.42	-3.0 ± 10.05	0.8 ± 9.64
Hemoglobin,Week 36,n=15,12,10,12,12	4.4 ± 7.97	4.8 ± 11.91	4.0 ± 7.26	-2.6 ± 10.93	1.3 ± 9.68
Hemoglobin,Week 40,n=14,11,8,10,10	1.3 ± 8.03	3.8 ± 12.40	6.3 ± 5.47	-3.4 ± 11.24	-0.4 ± 7.86
Hemoglobin,Week 44,n=11,10,6,8,9	0.0 ± 8.00	6.7 ± 14.60	2.3 ± 7.84	-0.3 ± 11.70	2.8 ± 12.85
Hemoglobin,Week 48,n=9,8,4,8,5	2.4 ± 7.57	4.8 ± 12.62	2.8 ± 12.69	-4.6 ± 14.66	7.6 ± 15.57
Hemoglobin,Week 52,n=8,5,5,5,4	2.9 ± 5.33	8.6 ± 12.84	10.4 ± 13.28	4.4 ± 6.47	2.8 ± 13.57

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in hematology parameter-Hematocrit

Top of page

End point title

Part A: Change from Baseline in hematology parameter-Hematocrit

End point description

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Week 2,n=38,39,24,24,25	0.0040 ± 0.01988	0.0060 ± 0.02186	0.0008 ± 0.02909	-0.0063 ± 0.02491	-0.0030 ± 0.01813
Week 4,n=36,37,24,22,27	0.0059 ± 0.01903	0.0048 ± 0.02635	0.0040 ± 0.01531	-0.0035 ± 0.02676	-0.0087 ± 0.02004
Week 8,n=34,29,23,22,21	0.0101 ± 0.02601	0.0054 ± 0.03213	0.0019 ± 0.02110	-0.0054 ± 0.03286	-0.0159 ± 0.01918
Week 12,n=31,28,23,22,22	0.0087 ± 0.02386	0.0148 ± 0.03272	0.0059 ± 0.01970	-0.0118 ± 0.03281	-0.0095 ± 0.02108
Week 16,n=27,26,21,19,19	-0.0037 ± 0.02187	0.0049 ± 0.02833	0.0008 ± 0.01961	-0.0135 ± 0.02976	-0.0095 ± 0.02347
Week 20,n=25,23,18,18,16	-0.0063 ± 0.02436	0.0066 ± 0.03019	-0.0015 ± 0.01398	-0.0184 ± 0.02972	-0.0062 ± 0.02076
Week 24,n=22,21,16,16,16	-0.0017 ± 0.02882	0.0010 ± 0.02839	0.0089 ± 0.01973	-0.0133 ± 0.03478	-0.0077 ± 0.01599
Week 28,n=18,18,12,14,13	-0.0089 ± 0.02917	0.0039 ± 0.03455	-0.0046 ± 0.01858	-0.0186 ± 0.02814	-0.0035 ± 0.02785
Week 32,n=19,15,10,12,13	-0.0076 ± 0.02782	0.0027 ± 0.02994	-0.0060 ± 0.03161	-0.0176 ± 0.02473	0.0025 ± 0.02741
Week 36,n=15,12,10,12,12	0.0012 ± 0.02603	0.0036 ± 0.03232	-0.0054 ± 0.01811	-0.0198 ± 0.02570	0.0018 ± 0.03090
Week 40,n=14,11,8,10,10	-0.0115 ± 0.03075	-0.0052 ± 0.03398	-0.0009 ± 0.01086	-0.0193 ± 0.02157	-0.0160 ± 0.02099
Week 44,n=11,10,6,7,9	-0.0185 ± 0.03039	0.0054 ± 0.03463	-0.0097 ± 0.02548	-0.0126 ± 0.03225	-0.0037 ± 0.03048
Week 48,n=9,8,4,8,5	-0.0136 ± 0.02709	-0.0025 ± 0.03217	-0.0053 ± 0.04366	-0.0216 ± 0.03428	0.0144 ± 0.04123
Week 52,n=8,5,5,5,4	-0.0135 ± 0.02112	0.0016 ± 0.04082	0.0058 ± 0.04370	-0.0006 ± 0.01558	0.0025 ± 0.03288

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume

Top of page

End point title

Part A: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Femtoliter
arithmetic mean (standard deviation)
Week 2,n=38,39,24,24,25	0.5 ± 1.35	0.5 ± 1.64	0.5 ± 1.38	0.6 ± 1.38	0.4 ± 1.44
Week 4,n=36,37,24,22,27	0.9 ± 1.95	1.1 ± 2.15	1.0 ± 1.69	0.6 ± 1.68	0.6 ± 2.28
Week 8,n=34,29,23,22,21	1.2 ± 2.54	1.8 ± 3.27	1.9 ± 2.72	1.7 ± 2.34	-0.2 ± 2.91
Week 12,n=31,28,23,22,22	0.8 ± 3.41	2.0 ± 4.29	2.6 ± 3.14	0.9 ± 3.16	0.3 ± 4.07
Week 16,n=27,26,21,19,19	1.0 ± 4.14	2.2 ± 4.36	3.1 ± 3.37	0.4 ± 4.03	-0.3 ± 4.98
Week 20,n=25,23,18,18,16	1.2 ± 4.42	1.8 ± 4.35	2.1 ± 3.12	-0.5 ± 4.72	0.1 ± 3.54
Week 24,n=22,21,16,16,16	1.1 ± 4.20	1.1 ± 3.91	2.6 ± 3.36	-1.0 ± 4.44	-1.6 ± 4.84
Week 28,n=18,18,12,14,13	0.6 ± 4.02	1.4 ± 4.19	2.0 ± 2.26	-0.4 ± 4.43	-0.5 ± 3.95
Week 32,n=19,15,10,12,13	0.9 ± 4.42	2.0 ± 4.44	1.3 ± 3.13	0.3 ± 4.89	-0.5 ± 3.64
Week 36,n=15,12,10,12,12	1.8 ± 3.49	1.6 ± 4.76	0.9 ± 2.47	-0.5 ± 4.93	-0.2 ± 2.55
Week 40,n=14,11,8,10,10	0.6 ± 3.73	1.8 ± 5.25	2.0 ± 2.83	0.4 ± 4.95	-2.1 ± 3.00
Week 44,n=11,10,6,8,9	-0.5 ± 3.50	2.5 ± 5.08	1.7 ± 3.50	-0.7 ± 6.87	-0.7 ± 2.83
Week 48,n=9,8,4,8,5	-0.4 ± 3.50	3.3 ± 4.95	2.3 ± 4.50	-1.1 ± 6.92	2.0 ± 2.12
Week 52,n=8,5,5,5,4	-0.6 ± 3.02	3.2 ± 5.12	1.4 ± 4.16	3.2 ± 5.72	1.0 ± 2.58

No statistical analyses for this end point

Secondary: Part A:Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin

Top of page

End point title

Part A:Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Picograms
arithmetic mean (standard deviation)
Week 2,n=38,39,24,24,25	0.13 ± 0.571	0.29 ± 0.730	0.42 ± 0.512	0.12 ± 0.494	0.22 ± 0.678
Week 4,n=36,37,24,22,27	0.53 ± 0.786	0.58 ± 0.877	0.55 ± 0.672	0.25 ± 0.458	0.36 ± 0.892
Week 8,n=34,29,23,22,21	0.96 ± 1.041	1.20 ± 1.056	1.16 ± 1.178	0.60 ± 0.751	0.49 ± 1.022
Week 12,n=31,28,23,22,22	0.94 ± 1.341	1.43 ± 1.372	1.38 ± 1.630	0.44 ± 1.110	0.47 ± 1.480
Week 16,n=27,26,21,19,19	1.16 ± 1.345	1.59 ± 1.617	1.83 ± 1.424	0.24 ± 1.508	0.22 ± 1.927
Week 20,n=25,23,18,18,16	1.24 ± 1.529	1.69 ± 1.605	1.48 ± 1.256	0.14 ± 1.666	0.39 ± 1.696
Week 24,n=22,21,16,16,16	0.97 ± 1.491	1.80 ± 1.663	1.34 ± 1.230	-0.04 ± 1.727	-0.08 ± 2.041
Week 28,n=18,18,12,14,13	0.91 ± 1.659	1.48 ± 1.618	1.47 ± 1.409	0.21 ± 2.000	-0.20 ± 1.493
Week 32,n=19,15,10,12,13	1.01 ± 1.498	1.57 ± 1.694	1.27 ± 1.111	0.68 ± 2.103	-0.14 ± 1.413
Week 36,n=15,12,10,12,12	1.42 ± 0.944	1.29 ± 1.905	1.39 ± 1.005	0.68 ± 2.327	0.15 ± 0.971
Week 40,n=14,11,8,10,10	1.30 ± 0.818	1.75 ± 1.914	1.91 ± 1.373	0.71 ± 2.617	0.44 ± 1.492
Week 44,n=11,10,6,8,9	1.16 ± 0.727	1.83 ± 2.214	1.63 ± 1.178	0.30 ± 2.460	0.77 ± 1.261
Week 48,n=9,8,4,8,5	1.36 ± 0.633	2.25 ± 2.194	1.73 ± 1.389	0.14 ± 2.934	1.32 ± 1.119
Week 52,n=8,5,5,5,4	1.44 ± 0.950	2.70 ± 1.744	2.24 ± 1.484	1.84 ± 1.889	0.80 ± 1.068

No statistical analyses for this end point

Secondary: Part A:Change from Baseline in hematology parameter- Erythrocytes

Top of page

End point title

Part A:Change from Baseline in hematology parameter- Erythrocytes

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: trillion cells per liter
arithmetic mean (standard deviation)
Week 2,n=38,39,24,24,25	0.01 ± 0.232	0.02 ± 0.265	-0.01 ± 0.303	-0.10 ± 0.254	-0.07 ± 0.221
Week 4,n=36,37,24,22,27	0.01 ± 0.208	-0.01 ± 0.311	-0.01 ± 0.202	-0.09 ± 0.268	-0.14 ± 0.248
Week 8,n=34,29,23,22,21	0.04 ± 0.249	-0.04 ± 0.406	-0.08 ± 0.300	-0.16 ± 0.372	-0.17 ± 0.219
Week 12,n=31,28,23,22,22	0.03 ± 0.255	0.05 ± 0.417	-0.07 ± 0.265	-0.20 ± 0.379	-0.11 ± 0.237
Week 16,n=27,26,21,19,19	-0.09 ± 0.238	-0.07 ± 0.312	-0.14 ± 0.282	-0.19 ± 0.399	-0.11 ± 0.303
Week 20,n=25,23,18,18,16	-0.13 ± 0.263	-0.03 ± 0.305	-0.12 ± 0.183	-0.20 ± 0.461	-0.08 ± 0.286
Week 24,n=22,21,16,16,16	-0.09 ± 0.270	-0.06 ± 0.282	-0.04 ± 0.234	-0.11 ± 0.464	-0.01 ± 0.289
Week 28,n=18,18,12,14,13	-0.14 ± 0.295	-0.04 ± 0.327	-0.16 ± 0.231	-0.18 ± 0.377	-0.02 ± 0.387
Week 32,n=19,15,10,12,13	-0.13 ± 0.292	-0.09 ± 0.259	-0.13 ± 0.330	-0.22 ± 0.321	0.04 ± 0.362
Week 36,n=15,12,10,12,12	-0.08 ± 0.262	-0.04 ± 0.378	-0.10 ± 0.183	-0.21 ± 0.358	0.03 ± 0.391
Week 40,n=14,11,8,10,10	-0.16 ± 0.234	-0.16 ± 0.380	-0.09 ± 0.189	-0.22 ± 0.301	-0.10 ± 0.330
Week 44,n=11,10,6,7,9	-0.18 ± 0.286	-0.10 ± 0.333	-0.17 ± 0.320	-0.10 ± 0.216	-0.03 ± 0.367
Week 48,n=9,8,4,8,5	-0.14 ± 0.240	-0.23 ± 0.266	-0.18 ± 0.457	-0.20 ± 0.251	0.04 ± 0.434
Week 52,n=8,5,5,5,4	-0.16 ± 0.283	-0.18 ± 0.370	-0.02 ± 0.531	-0.18 ± 0.192	-0.05 ± 0.332

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea

Top of page

End point title

Part A: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea

End point description

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Millimoles per liter
arithmetic mean (standard deviation)
calcium,Week 2,n=38,39,26,24,26	0.002 ± 0.1056	0.006 ± 0.0853	-0.008 ± 0.0817	0.008 ± 0.1050	0.013 ± 0.0812
calcium,Week 4,n=37,38,25,23,27	0.009 ± 0.0974	0.008 ± 0.0968	0.013 ± 0.0649	-0.016 ± 0.0922	-0.001 ± 0.0899
calcium,Week 8,n=34,31,24,22,23	0.032 ± 0.1114	0.049 ± 0.0879	0.005 ± 0.0764	0.020 ± 0.0918	0.013 ± 0.0615
calcium,Week 12,n=32,28,24,22,21	0.019 ± 0.1200	0.072 ± 0.0789	-0.001 ± 0.0750	0.011 ± 0.0913	0.016 ± 0.0851
calcium,Week 16,n=28,26,22,19,18	0.009 ± 0.0974	0.050 ± 0.0808	0.018 ± 0.0954	-0.008 ± 0.0707	0.044 ± 0.0768
calcium,Week 20,n=25,23,19,18,16	0.018 ± 0.1080	0.070 ± 0.0987	0.032 ± 0.0933	0.000 ± 0.0884	0.012 ± 0.0932
calcium,Week 24,n=22,21,16,17,16	0.008 ± 0.1029	0.064 ± 0.0927	0.032 ± 0.1077	-0.002 ± 0.0748	0.009 ± 0.0702
calcium,Week 28,n=19,18,12,13,14	0.006 ± 0.1102	0.066 ± 0.1106	0.054 ± 0.1232	0.018 ± 0.0838	0.076 ± 0.1108
calcium,Week 32,n=19,15,10,12,13	0.029 ± 0.1119	0.044 ± 0.0923	0.059 ± 0.0737	-0.008 ± 0.0978	0.075 ± 0.1271
calcium,Week 36,n=15,12,10,12,13	0.016 ± 0.0789	0.055 ± 0.0773	0.075 ± 0.0738	-0.038 ± 0.1025	0.053 ± 0.0957
calcium,Week 40,n=15,11,9,10,10	0.077 ± 0.1012	0.016 ± 0.0662	0.008 ± 0.0930	-0.042 ± 0.0561	0.037 ± 0.0589
calcium,Week 44,n=11,11,6,8,9	0.042 ± 0.1480	0.025 ± 0.0908	-0.002 ± 0.0475	-0.035 ± 0.1638	0.054 ± 0.1146
calcium,Week 48,n=9,8,5,8,5	-0.007 ± 0.1126	0.028 ± 0.0956	-0.018 ± 0.0769	-0.035 ± 0.0769	0.142 ± 0.0782
calcium,Week 52,n=9,5,5,5,4	0.013 ± 0.0907	0.076 ± 0.1108	0.026 ± 0.0747	-0.056 ± 0.1161	0.083 ± 0.0624
Carbon Dioxide,Week 2,n=38,39,26,24,26	0.7 ± 2.42	0.6 ± 2.55	0.5 ± 2.53	-0.3 ± 2.31	0.7 ± 2.24
Carbon Dioxide,Week 4,n=37,38,25,23,27	0.1 ± 2.03	0.2 ± 2.68	0.4 ± 2.69	0.2 ± 1.75	0.1 ± 2.83
Carbon Dioxide,Week 8,n=34,31,24,22,23	0.1 ± 3.39	0.3 ± 2.89	0.0 ± 2.69	0.0 ± 2.01	1.1 ± 2.24
Carbon Dioxide,Week 12,n=32,28,24,22,21	0.1 ± 2.66	0.6 ± 2.53	-0.4 ± 2.28	0.0 ± 1.94	1.2 ± 1.73
Carbon Dioxide,Week 16,n=28,26,22,19,18	0.1 ± 2.97	0.5 ± 2.47	0.8 ± 2.94	-0.1 ± 1.88	0.5 ± 2.55
Carbon Dioxide,Week 20,n=25,23,19,18,16	0.1 ± 2.98	-0.1 ± 3.17	-0.1 ± 2.70	-0.3 ± 2.83	0.5 ± 2.68
Carbon Dioxide,Week 24,n=22,21,16,17,16	0.4 ± 3.10	0.4 ± 3.11	-0.8 ± 2.65	0.5 ± 2.29	-0.2 ± 2.61
Carbon Dioxide,Week 28,n=19,18,12,13,14	-1.6 ± 2.83	0.4 ± 3.63	-1.0 ± 2.04	-0.4 ± 2.36	0.4 ± 3.08
Carbon Dioxide,Week 32,n=19,15,10,12,13	-1.0 ± 3.65	0.8 ± 2.08	-1.4 ± 2.17	-0.6 ± 2.43	0.2 ± 2.24
Carbon Dioxide,Week 36,n=15,12,10,12,13	-1.1 ± 2.28	0.3 ± 3.72	-0.9 ± 1.97	-0.3 ± 3.63	1.0 ± 2.16
Carbon Dioxide,Week 40,n=15,11,6,10,10	-1.5 ± 3.16	0.9 ± 3.75	-1.7 ± 2.35	-0.8 ± 2.70	0.4 ± 1.43
Carbon Dioxide,Week 44,n=11,11,6,8,9	-1.7 ± 2.72	1.6 ± 3.50	0.0 ± 3.03	-1.6 ± 1.60	-0.1 ± 2.47
Carbon Dioxide,Week 48,n=9,8,5,8,5	-2.6 ± 2.70	0.5 ± 3.59	-1.0 ± 2.65	0.0 ± 1.77	-0.2 ± 2.17
Carbon Dioxide,Week 52,n=9,5,5,5,4	-1.1 ± 1.76	1.2 ± 2.68	-1.2 ± 1.48	-0.4 ± 1.34	1.8 ± 2.87
Chloride,Week 2,n=38,39,26,24,26	1.1 ± 2.36	0.6 ± 1.79	0.7 ± 1.76	1.0 ± 2.16	0.8 ± 2.77
Chloride,Week 4,n=37,38,25,23,27	1.8 ± 2.34	1.6 ± 2.10	1.4 ± 1.87	0.7 ± 2.14	1.4 ± 2.79
Chloride,Week 8,n=34,31,24,22,23	2.5 ± 2.12	2.4 ± 2.06	2.0 ± 2.65	1.0 ± 2.18	2.1 ± 3.24
Chloride,Week 12,n=32,28,24,22,21	2.9 ± 2.54	1.8 ± 3.03	2.4 ± 2.30	0.6 ± 2.06	2.0 ± 2.36
Chloride,Week 16,n=28,26,22,19,18	3.0 ± 2.27	2.3 ± 2.54	2.2 ± 2.46	1.1 ± 2.04	2.4 ± 3.40
Chloride,Week 20,n=25,23,19,18,16	3.3 ± 2.88	2.0 ± 2.11	2.1 ± 2.49	1.3 ± 2.22	2.5 ± 3.12
Chloride,Week 24,n=22,21,16,17,16	3.4 ± 3.42	2.7 ± 2.51	1.6 ± 3.16	1.0 ± 2.12	2.3 ± 3.55
Chloride,Week 28,n=19,18,12,13,14	3.9 ± 3.13	2.8 ± 2.80	2.8 ± 2.49	0.2 ± 3.49	2.9 ± 3.63
Chloride,Week 32,n=19,15,10,12,13	3.4 ± 2.73	1.9 ± 2.59	2.0 ± 2.26	-0.1 ± 4.17	3.4 ± 3.43
Chloride,Week 36,n=15,12,10,12,13	3.8 ± 1.74	2.4 ± 2.78	1.9 ± 2.47	1.1 ± 1.88	2.8 ± 3.37
Chloride,Week 40,n=15,11,9,10,10	3.3 ± 2.49	3.6 ± 1.12	1.4 ± 1.94	1.9 ± 1.45	3.9 ± 3.03
Chloride,Week 44,n=11,11,6,8,9	3.8 ± 2.23	3.4 ± 1.91	0.2 ± 2.14	1.1 ± 2.03	2.2 ± 4.52
Chloride,Week 48,n=9,8,5,8,5	4.6 ± 1.88	2.1 ± 2.23	2.0 ± 1.58	1.8 ± 1.58	2.8 ± 3.11
Chloride,Week 52,n=9,5,5,5,4	4.8 ± 1.09	2.2 ± 1.64	0.2 ± 3.83	3.6 ± 1.95	3.8 ± 4.11
Glucose,Week 2,n=38,39,26,24,26	-0.03 ± 2.568	-0.46 ± 1.671	0.01 ± 1.237	0.29 ± 1.358	-0.44 ± 3.578
Glucose,Week 4,n=37,38,25,23,27	-0.10 ± 2.676	-0.35 ± 1.929	0.38 ± 1.601	0.31 ± 1.466	-0.03 ± 4.387
Glucose,Week 8,n=34,31,24,22,23	-0.29 ± 2.507	-0.58 ± 2.606	-0.12 ± 1.265	0.10 ± 1.579	-1.15 ± 5.685
Glucose,Week 12,n=32,28,24,22,21	-0.64 ± 2.219	-0.63 ± 2.134	-0.33 ± 1.163	-0.25 ± 1.164	-1.76 ± 5.919
Glucose,Week 16,n=28,26,22,19,18	-0.71 ± 2.485	0.33 ± 1.941	-0.29 ± 1.113	-0.12 ± 1.414	-1.15 ± 6.411
Glucose,Week 20,n=25,23,19,18,16	-0.66 ± 2.701	-0.46 ± 1.550	0.46 ± 1.714	-0.33 ± 1.435	-1.96 ± 7.018
Glucose,Week 24,n=22,21,16,17,16	-0.72 ± 2.701	-0.44 ± 1.632	-0.23 ± 1.217	-0.38 ± 1.290	-2.08 ± 6.953
Glucose,Week 28,n=19,18,12,13,14	-0.91 ± 2.990	-0.32 ± 1.510	0.58 ± 1.627	-0.25 ± 1.278	-2.05 ± 7.699
Glucose,Week 32,n=19,15,10,12,13	-0.74 ± 3.492	-0.48 ± 1.533	0.72 ± 1.795	-0.05 ± 1.363	-3.12 ± 7.818
Glucose,Week 36,n=15,12,10,12,13	-1.14 ± 3.268	-0.35 ± 1.861	0.05 ± 1.019	-0.50 ± 1.261	-2.98 ± 7.786
Glucose,Week 40,n=15,11,9,10,10	-0.99 ± 3.465	-0.33 ± 2.376	0.22 ± 1.203	-0.22 ± 1.192	-0.94 ± 3.589
Glucose,Week 44,n=11,11,6,8,9	-1.39 ± 3.789	-0.05 ± 1.954	-0.27 ± 0.940	0.30 ± 0.739	-0.23 ± 2.001
Glucose,Week 48,n=9,8,5,8,5	-1.39 ± 4.249	-0.93 ± 2.077	-0.62 ± 1.441	-0.88 ± 1.369	-0.36 ± 2.196
Glucose,Week 52,n=9,5,5,5,4	-1.51 ± 4.466	-0.94 ± 2.707	-0.26 ± 1.316	-0.72 ± 1.308	0.45 ± 2.353
Phosphate,Week 2,n=38,39,26,24,26	0.056 ± 0.2249	-0.004 ± 0.1930	0.017 ± 0.1886	-0.025 ± 0.1622	0.005 ± 0.1601
Phosphate,Week 4,n=37,38,25,23,27	0.071 ± 0.1944	-0.011 ± 0.2501	0.093 ± 0.1848	0.006 ± 0.1883	0.008 ± 0.2087
Phosphate,Week 8,n=34,31,24,22,23	0.088 ± 0.1786	0.091 ± 0.2098	0.112 ± 0.1588	0.045 ± 0.1971	0.055 ± 0.1746
Phosphate,Week 12,n=32,28,24,22,21	0.122 ± 0.2404	0.154 ± 0.2377	0.190 ± 0.1725	0.067 ± 0.1873	0.079 ± 0.1946
Phosphate,Week 16,n=28,26,22,19,18	0.113 ± 0.1976	0.139 ± 0.2315	0.146 ± 0.1612	0.025 ± 0.1589	0.039 ± 0.2238
Phosphate,Week 20,n=25,23,19,18,16	0.070 ± 0.1860	0.160 ± 0.2436	0.141 ± 0.2257	0.043 ± 0.1854	0.060 ± 0.2183
Phosphate,Week 24,n=22,21,16,17,16	0.132 ± 0.2066	0.163 ± 0.2383	0.181 ± 0.1778	0.055 ± 0.1728	0.101 ± 0.1811
Phosphate,Week 28,n=19,18,12,13,14	0.156 ± 0.1873	0.090 ± 0.2543	0.191 ± 0.1980	0.073 ± 0.2017	0.190 ± 0.3143
Phosphate,Week 32,n=19,15,10,12,13	0.164 ± 0.1166	0.101 ± 0.2160	0.214 ± 0.2086	0.048 ± 0.1677	0.155 ± 0.2713
Phosphate,Week 36,n=15,12,10,12,13	0.111 ± 0.1786	0.068 ± 0.2204	0.304 ± 0.2112	0.098 ± 0.1939	0.151 ± 0.2114
Phosphate,Week 40,n=15,11,6,10,10	0.221 ± 0.1902	-0.007 ± 0.2007	0.104 ± 0.1948	0.073 ± 0.1849	0.206 ± 0.2151
Phosphate,Week 44,n=11,11,6,8,9	0.142 ± 0.2117	0.025 ± 0.1874	0.090 ± 0.2131	-0.065 ± 0.2267	0.218 ± 0.2184
Phosphate,Week 48,n=9,8,5,8,5	0.029 ± 0.2136	-0.054 ± 0.2203	0.028 ± 0.2611	-0.015 ± 0.1561	0.132 ± 0.1972
Phosphate,Week 52,n=9,5,5,5,4	0.049 ± 0.2235	-0.036 ± 0.2779	0.208 ± 0.1583	0.036 ± 0.0865	0.115 ± 0.1434
Potassium,Week 2,n=38,39,26,24,26	0.03 ± 0.372	-0.03 ± 0.437	-0.02 ± 0.401	0.18 ± 0.336	0.08 ± 0.375
Potassium,Week 4,n=37,38,25,23,27	-0.13 ± 0.319	-0.04 ± 0.412	-0.10 ± 0.453	0.06 ± 0.329	-0.03 ± 0.343
Potassium,Week 8,n=34,31,24,22,23	0.01 ± 0.364	0.05 ± 0.437	-0.11 ± 0.422	0.10 ± 0.333	0.06 ± 0.399
Potassium,Week 12,n=32,28,24,22,21	-0.12 ± 0.333	0.15 ± 0.810	-0.10 ± 0.346	0.06 ± 0.336	0.04 ± 0.446
Potassium,Week 16,n=28,26,22,19,18	0.01 ± 0.376	0.03 ± 0.439	-0.02 ± 0.358	0.15 ± 0.345	0.15 ± 0.279
Potassium,Week 20,n=25,23,19,18,16	0.04 ± 0.394	0.07 ± 0.556	0.02 ± 0.417	0.10 ± 0.287	0.16 ± 0.390
Potassium,Week 24,n=22,21,16,17,16	0.05 ± 0.447	-0.01 ± 0.403	-0.13 ± 0.368	0.15 ± 0.371	0.16 ± 0.411
Potassium,Week 28,n=19,18,12,13,14	0.12 ± 0.288	0.07 ± 0.470	0.17 ± 0.414	0.08 ± 0.297	0.23 ± 0.418
Potassium,Week 32,n=19,15,10,12,13	0.16 ± 0.437	0.01 ± 0.448	0.17 ± 0.333	0.19 ± 0.365	0.25 ± 0.443
Potassium,Week 36,n=15,12,10,12,13	0.16 ± 0.429	-0.07 ± 0.475	0.18 ± 0.408	0.18 ± 0.341	0.21 ± 0.403
Potassium,Week 40,n=15,11,9,10,10	0.24 ± 0.534	-0.03 ± 0.476	0.01 ± 0.276	0.03 ± 0.450	0.28 ± 0.355
Potassium,Week 44,n=11,11,6,8,9	0.16 ± 0.287	-0.13 ± 0.478	-0.13 ± 0.288	0.15 ± 0.385	0.16 ± 0.488
Potassium,Week 48,n=9,8,5,8,5	0.21 ± 0.352	0.06 ± 0.644	-0.04 ± 0.182	0.16 ± 0.283	0.52 ± 0.432
Potassium,Week 52,n=9,5,5,5,4	0.22 ± 0.186	-0.16 ± 0.434	-0.10 ± 0.418	0.06 ± 0.445	0.20 ± 0.365
Sodium,Week 2,n=38,39,26,24,26	0.3 ± 2.11	0.0 ± 2.33	-0.8 ± 2.37	-0.2 ± 1.52	0.9 ± 2.92
Sodium,Week 4,n=37,38,25,23,27	0.7 ± 2.15	0.4 ± 2.11	0.2 ± 2.29	0.0 ± 1.43	0.6 ± 2.65
Sodium,Week 8,n=34,31,24,22,23	1.1 ± 2.10	0.9 ± 3.12	0.1 ± 2.32	0.5 ± 1.50	1.7 ± 2.91
Sodium,Week 12,n=32,28,24,22,21	1.8 ± 2.46	0.5 ± 3.90	0.6 ± 1.76	0.5 ± 1.79	2.1 ± 2.37
Sodium,Week 16,n=28,26,22,19,18	1.0 ± 2.28	0.6 ± 3.09	-0.2 ± 2.25	-0.3 ± 1.37	2.3 ± 3.59
Sodium,Week 20,n=25,23,19,18,16	1.0 ± 2.23	0.6 ± 2.79	-0.3 ± 2.60	-0.6 ± 0.92	2.3 ± 3.52
Sodium,Week 24,n=22,21,16,17,16	0.9 ± 2.31	1.0 ± 1.83	-0.4 ± 2.00	0.4 ± 1.50	1.9 ± 2.96
Sodium,Week 28,n=19,18,12,13,14	0.9 ± 2.27	1.2 ± 2.75	0.5 ± 1.93	-0.8 ± 3.22	2.4 ± 3.54
Sodium,Week 32,n=19,15,10,12,13	0.7 ± 2.31	-0.3 ± 2.63	-0.2 ± 2.04	-0.8 ± 3.16	3.2 ± 4.13
Sodium,Week 36,n=15,12,10,12,13	0.5 ± 1.96	0.6 ± 2.43	-0.4 ± 2.07	-0.2 ± 1.85	2.8 ± 3.60
Sodium,Week 40,n=15,11,9,10,10	0.1 ± 2.17	1.2 ± 2.23	-1.2 ± 2.49	0.5 ± 1.58	2.9 ± 3.07
Sodium,Week 44,n=11,11,6,8,9	0.5 ± 1.97	0.4 ± 2.58	-2.0 ± 2.53	-0.8 ± 1.28	1.8 ± 3.77
Sodium,Week 48,n=9,8,5,8,5	-0.3 ± 1.87	0.8 ± 2.76	-0.6 ± 2.07	0.3 ± 1.91	1.6 ± 2.70
Sodium,Week 52,n=9,5,5,5,4	0.7 ± 1.66	0.4 ± 2.51	-0.8 ± 3.11	1.6 ± 1.14	3.5 ± 3.32
Urea,Week 2,n=38,39,26,24,26	0.05 ± 1.210	-0.16 ± 1.776	0.28 ± 1.439	-0.31 ± 1.458	-0.32 ± 1.240
Urea,Week 4,n=37,38,25,23,27	-0.09 ± 1.592	-0.61 ± 1.514	-0.06 ± 1.277	-0.22 ± 1.022	-0.27 ± 1.700
Urea,Week 8,n=34,31,24,22,23	-0.36 ± 1.938	-0.99 ± 1.826	-0.40 ± 1.574	-0.91 ± 0.970	-0.34 ± 0.965
Urea,Week 12,n=32,28,24,22,21	-0.65 ± 1.617	-1.20 ± 1.778	-0.62 ± 1.501	-1.12 ± 1.457	-0.35 ± 1.316
Urea,Week 16,n=28,26,22,19,18	-0.56 ± 2.009	-0.52 ± 1.612	-0.72 ± 1.232	-0.40 ± 1.580	-0.07 ± 1.701
Urea,Week 20,n=25,23,19,18,16	-0.30 ± 1.675	-0.70 ± 1.379	-0.70 ± 1.197	-0.31 ± 1.470	-0.77 ± 1.900
Urea,Week 24,n=22,21,16,17,16	-0.48 ± 1.901	-0.22 ± 2.044	-0.80 ± 1.717	-0.65 ± 1.457	-0.64 ± 2.019
Urea,Week 28,n=19,18,12,13,14	-0.45 ± 1.745	-0.42 ± 1.510	-0.73 ± 1.317	0.23 ± 1.111	-0.31 ± 1.495
Urea,Week 32,n=19,15,10,12,13	-0.16 ± 2.086	-0.64 ± 1.479	-0.83 ± 1.382	-0.76 ± 1.071	0.17 ± 2.609
Urea,Week 36,n=15,12,10,12,13	0.06 ± 1.967	-1.43 ± 1.828	-0.93 ± 1.113	-0.01 ± 0.973	-0.22 ± 2.297
Urea,Week 40,n=15,11,9,10,10	-0.17 ± 1.775	-0.78 ± 0.603	-0.98 ± 1.237	-0.76 ± 1.552	0.32 ± 1.886
Urea,Week 44,n=11,11,6,8,9	-0.46 ± 3.119	-1.05 ± 1.234	-0.63 ± 1.359	-0.76 ± 1.274	-1.09 ± 1.727
Urea,Week 48,n=9,8,5,8,5	-0.18 ± 3.535	-1.58 ± 1.450	-0.06 ± 1.311	-0.51 ± 1.225	0.44 ± 1.282
Urea,Week 52,n=9,5,5,5,4	-0.26 ± 2.508	-1.22 ± 1.671	-0.76 ± 1.647	-0.82 ± 0.782	-0.45 ± 1.475

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Albumin and Protein

Top of page

End point title

Part A: Change from Baseline in clinical chemistry parameters: Albumin and Protein

End point description

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Grams per liter
arithmetic mean (standard deviation)
Albumin,Week 2,n=38,39,26,24,26	0.3 ± 2.29	0.9 ± 1.79	0.8 ± 1.88	-0.9 ± 2.64	-0.7 ± 2.24
Albumin,Week 4,n=37,38,25,23,27	0.9 ± 2.41	2.0 ± 2.84	1.6 ± 1.50	-1.4 ± 2.46	-0.9 ± 2.46
Albumin,Week 8,n=34,31,24,22,23	1.9 ± 2.76	3.1 ± 2.35	2.1 ± 1.85	-1.1 ± 2.35	-0.6 ± 1.80
Albumin,Week 12,n=32,28,24,22,21	2.0 ± 2.26	3.4 ± 2.50	3.1 ± 1.54	-0.5 ± 2.81	0.2 ± 1.87
Albumin,Week 16,n=28,26,22,19,18	1.7 ± 2.29	2.8 ± 2.52	2.8 ± 2.44	-1.2 ± 2.41	0.6 ± 2.48
Albumin,Week 20,n=25,23,19,18,16	1.8 ± 2.46	3.9 ± 2.68	2.8 ± 2.15	-0.9 ± 2.70	0.3 ± 2.11
Albumin,Week 24,n=22,21,16,17,16	1.6 ± 2.77	3.8 ± 2.36	3.7 ± 1.85	0.0 ± 2.83	0.3 ± 1.88
Albumin,Week 28,n=19,18,12,13,14	1.5 ± 1.61	3.5 ± 3.38	2.4 ± 2.78	-0.5 ± 2.82	0.4 ± 2.98
Albumin,Week 32,n=19,15,10,12,13	2.2 ± 2.03	3.6 ± 3.68	2.2 ± 2.66	-0.7 ± 3.20	1.1 ± 2.93
Albumin,Week 36,n=15,12,10,12,13	3.1 ± 2.61	4.3 ± 3.75	2.9 ± 2.08	-1.3 ± 3.25	0.2 ± 3.02
Albumin,Week 40,n=15,11,9,10,10	3.2 ± 1.97	3.9 ± 3.78	2.4 ± 2.07	-1.1 ± 2.96	-0.5 ± 2.27
Albumin,Week 44,n=11,11,6,8,9	3.2 ± 2.36	4.1 ± 3.36	2.2 ± 2.23	0.4 ± 3.07	0.6 ± 2.19
Albumin,Week 48,n=9,8,5,8,5	3.4 ± 2.13	4.4 ± 3.20	1.6 ± 2.70	-0.8 ± 3.28	2.0 ± 2.92
Albumin,Week 52,n=9,5,5,5,4	3.7 ± 2.45	5.2 ± 1.64	4.0 ± 2.55	-1.2 ± 0.84	1.5 ± 4.12
Protein,Week 2,n=38,39,26,24,26	-2.6 ± 3.68	-2.4 ± 3.13	-1.9 ± 2.73	-1.7 ± 3.31	-1.7 ± 3.16
Protein,Week 4,n=37,38,25,23,27	-2.5 ± 3.49	-2.4 ± 4.39	-1.8 ± 2.81	-2.0 ± 3.64	-2.0 ± 4.05
Protein,Week 8,n=34,31,24,22,23	-1.9 ± 3.53	-1.6 ± 4.16	-2.2 ± 3.67	-0.7 ± 3.10	-0.7 ± 3.30
Protein,Week 12,n=32,28,24,22,21	-1.7 ± 3.19	-1.3 ± 3.72	-0.8 ± 3.06	1.0 ± 3.68	0.9 ± 3.67
Protein,Week 16,n=28,26,22,19,18	-2.3 ± 3.43	-2.0 ± 3.67	-1.9 ± 3.70	0.2 ± 3.20	1.0 ± 3.68
Protein,Week 20,n=25,23,19,18,16	-1.9 ± 3.44	-0.4 ± 4.69	-1.3 ± 2.84	0.6 ± 3.45	0.4 ± 2.63
Protein,Week 24,n=22,21,16,17,16	-1.1 ± 3.64	-0.9 ± 4.39	0.0 ± 2.85	1.5 ± 4.86	0.8 ± 3.09
Protein,Week 28,n=19,18,12,13,14	-2.4 ± 3.30	-0.8 ± 5.27	-2.7 ± 2.67	-0.2 ± 4.39	1.6 ± 4.20
Protein,Week 32,n=19,15,10,12,13	-1.4 ± 3.52	-1.5 ± 4.67	-2.1 ± 4.07	-0.3 ± 4.45	2.6 ± 3.78
Protein,Week 36,n=15,12,10,12,13	-0.3 ± 3.48	-0.8 ± 4.69	-0.5 ± 2.51	-0.3 ± 4.11	1.8 ± 3.51
Protein,Week 40,n=15,11,9,10,10	-0.5 ± 3.38	-1.5 ± 4.93	-2.1 ± 1.76	-0.4 ± 3.27	1.4 ± 3.03
Protein,Week 44,n=11,11,6,8,9	0.3 ± 2.65	-0.4 ± 4.06	-2.0 ± 3.52	2.3 ± 5.50	1.7 ± 2.60
Protein,Week 48,n=9,8,5,8,5	0.3 ± 4.69	-0.1 ± 3.76	-1.8 ± 4.49	1.4 ± 4.98	3.2 ± 2.28
Protein,Week 52,n=9,5,5,5,4	-0.4 ± 3.54	1.0 ± 4.69	0.6 ± 4.88	-1.0 ± 3.54	1.8 ± 4.43

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Top of page

End point title

Part A: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

End point description

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: International units per liter
arithmetic mean (standard deviation)
ALT,Week 2,n=38,39,26,24,26	8.2 ± 17.71	5.3 ± 14.63	10.1 ± 23.12	-0.6 ± 3.27	1.8 ± 15.16
ALT,Week 4,n=37,38,25,23,27	6.6 ± 11.17	6.6 ± 16.09	5.2 ± 6.10	-1.2 ± 4.20	-3.1 ± 9.80
ALT,Week 8,n=34,31,24,22,23	6.0 ± 14.70	9.5 ± 12.71	4.7 ± 8.25	-2.8 ± 4.19	-6.8 ± 12.81
ALT,Week 12,n=32,28,24,22,21	4.7 ± 6.91	4.4 ± 10.82	4.0 ± 6.85	-3.3 ± 5.39	-7.0 ± 11.88
ALT,Week 16,n=28,26,22,19,18	4.1 ± 8.11	2.2 ± 9.86	5.2 ± 10.08	-3.5 ± 5.23	-6.6 ± 14.22
ALT,Week 20,n=25,23,19,18,16	16.1 ± 51.67	4.9 ± 15.83	8.6 ± 11.73	2.3 ± 22.33	-8.1 ± 14.38
ALT,Week 24,n=22,21,16,17,16	8.3 ± 13.62	2.5 ± 14.71	16.4 ± 33.68	-2.8 ± 6.58	-9.4 ± 13.61
ALT,Week 28,n=19,18,12,13,14	6.7 ± 8.75	2.9 ± 14.59	12.1 ± 23.96	-1.9 ± 3.95	-8.9 ± 12.65
ALT,Week 32,n=19,15,10,12,13	6.6 ± 11.06	5.0 ± 14.05	5.1 ± 9.45	-2.0 ± 4.45	-10.0 ± 12.40
ALT,Week 36,n=15,12,10,12,13	8.7 ± 13.58	6.0 ± 15.22	4.5 ± 8.44	-2.8 ± 2.77	-10.0 ± 13.87
ALT,Week 40,n=15,11,9,10,10	5.3 ± 8.85	7.3 ± 19.52	5.4 ± 5.61	0.1 ± 11.82	-2.1 ± 6.77
ALT,Week 44,n=11,11,6,8,9	1.8 ± 5.51	5.5 ± 15.53	2.7 ± 7.09	-0.4 ± 7.15	-7.0 ± 4.42
ALT,Week 48,n=9,8,5,8,5	2.3 ± 6.54	4.5 ± 16.52	3.6 ± 10.48	-3.5 ± 3.12	0.2 ± 11.50
ALT,Week 52,n=9,5,5,5,4	1.3 ± 5.98	1.6 ± 19.63	8.8 ± 10.03	-4.4 ± 1.52	5.3 ± 20.81
ALP,Week 2,n=38,39,26,24,26	-9.3 ± 15.76	-11.4 ± 7.46	-11.4 ± 8.50	-3.0 ± 5.88	-2.6 ± 5.81
ALP,Week 4,n=37,38,25,23,27	-15.5 ± 13.96	-13.4 ± 12.75	-14.2 ± 10.17	-2.2 ± 8.83	5.3 ± 27.51
ALP,Week 8,n=34,31,24,22,23	-16.8 ± 11.61	-10.4 ± 13.73	-15.3 ± 7.14	2.9 ± 9.95	1.6 ± 33.37
ALP,Week 12,n=32,28,24,22,21	-19.2 ± 15.60	-7.0 ± 10.15	-15.0 ± 8.06	6.6 ± 13.21	-5.3 ± 16.83
ALP,Week 16,n=28,26,22,19,18	-18.2 ± 15.36	-8.0 ± 12.61	-14.6 ± 8.56	1.1 ± 12.90	-0.3 ± 14.43
ALP,Week 20,n=25,23,19,18,16	-14.4 ± 21.82	-4.4 ± 12.89	-13.3 ± 9.58	5.9 ± 19.44	-1.0 ± 12.41
ALP,Week 24,n=22,21,16,17,16	-16.3 ± 20.32	-6.2 ± 13.76	-12.5 ± 9.08	6.9 ± 16.34	-1.8 ± 20.27
ALP,Week 28,n=19,18,12,13,14	-17.6 ± 23.06	-4.3 ± 14.99	-17.5 ± 6.56	1.6 ± 13.28	2.9 ± 19.72
ALP,Week 32,n=19,15,10,12,13	-15.9 ± 22.94	-6.1 ± 11.89	-12.6 ± 6.93	-2.3 ± 17.00	5.2 ± 18.44
ALP,Week 36,n=15,12,10,12,13	-20.3 ± 24.22	-7.3 ± 11.18	-9.6 ± 12.51	-1.8 ± 15.49	7.3 ± 20.95
ALP,Week 40,n=15,11,9,10,10	-14.5 ± 22.71	-7.4 ± 10.16	-9.9 ± 11.35	-0.2 ± 15.17	12.3 ± 24.69
ALP,Week 44,n=11,11,6,8,9	-19.4 ± 24.30	-6.2 ± 13.48	-4.0 ± 10.86	2.8 ± 19.93	11.9 ± 24.93
ALP,Week 48,n=9,8,5,8,5	-24.4 ± 28.77	-6.5 ± 8.45	-4.4 ± 12.82	1.5 ± 18.31	7.2 ± 17.06
ALP,Week 52,n=9,5,5,5,4	-26.0 ± 29.20	-8.0 ± 9.14	-3.6 ± 7.60	1.0 ± 19.34	-1.5 ± 11.00
AST,Week 2,n=38,39,26,24,26	6.1 ± 8.07	3.7 ± 4.81	4.5 ± 7.11	-0.3 ± 2.66	0.4 ± 6.18
AST,Week 4,n=37,38,25,23,27	5.4 ± 8.43	5.9 ± 6.74	5.0 ± 3.96	-1.0 ± 2.75	-0.7 ± 7.10
AST,Week 8,n=34,31,24,22,23	6.4 ± 6.43	10.6 ± 8.90	6.7 ± 7.90	0.1 ± 2.74	-1.6 ± 7.72
AST,Week 12,n=32,28,24,22,21	7.6 ± 9.02	9.0 ± 5.64	6.5 ± 5.24	0.5 ± 3.62	0.1 ± 8.74
AST,Week 16,n=28,26,22,19,18	8.5 ± 8.94	7.0 ± 5.79	8.0 ± 7.28	0.2 ± 4.45	1.0 ± 11.88
AST,Week 20,n=25,23,19,18,16	14.6 ± 27.52	7.7 ± 7.24	9.0 ± 7.46	4.3 ± 20.22	1.4 ± 12.10
AST,Week 24,n=22,21,16,17,16	9.8 ± 8.52	7.6 ± 6.75	10.5 ± 10.02	0.6 ± 4.40	-1.3 ± 8.29
AST,Week 28,n=19,18,12,13,14	9.0 ± 7.23	8.1 ± 7.30	9.4 ± 10.61	1.1 ± 3.88	-0.1 ± 9.01
AST,Week 32,n=19,15,10,12,13	8.8 ± 7.63	9.2 ± 7.72	8.0 ± 4.94	0.6 ± 3.65	1.2 ± 9.49
AST,Week 36,n=15,12,10,12,13	10.6 ± 8.85	10.8 ± 8.09	7.6 ± 5.02	1.3 ± 2.56	0.2 ± 9.27
AST,Week 40,n=15,11,9,10,10	8.9 ± 4.56	8.7 ± 10.82	9.1 ± 4.11	4.7 ± 13.17	6.7 ± 11.36
AST,Week 44,n=11,11,6,8,9	8.1 ± 3.56	9.2 ± 8.91	8.3 ± 5.09	3.5 ± 4.81	2.3 ± 3.24
AST,Week 48,n=9,8,5,8,5	8.1 ± 4.04	11.8 ± 12.63	9.8 ± 7.29	1.3 ± 4.68	6.4 ± 5.59
AST,Week 52,n=9,5,5,5,4	7.1 ± 3.33	9.2 ± 4.97	11.6 ± 5.68	-0.2 ± 3.63	4.3 ± 6.85

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin

Top of page

End point title

Part A: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin

End point description

Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	42	39	26	27	27
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin,Week 2,n=38,39,26,24,26	1.8 ± 2.73	1.5 ± 3.12	1.9 ± 3.73	-1.1 ± 1.94	-1.0 ± 3.45
Bilirubin,Week 4,n=37,38,25,23,27	2.4 ± 5.05	1.9 ± 3.10	1.8 ± 2.76	-1.8 ± 2.52	-1.5 ± 5.22
Bilirubin,Week 8,n=34,31,24,22,23	3.0 ± 3.58	2.8 ± 4.81	0.9 ± 2.95	-2.3 ± 2.50	-3.2 ± 5.31
Bilirubin,Week 12,n=32,28,24,22,21	4.3 ± 8.49	2.8 ± 3.58	2.7 ± 3.44	-1.0 ± 2.40	-2.9 ± 4.52
Bilirubin,Week 16,n=28,26,22,19,18	2.7 ± 4.68	4.4 ± 4.53	3.9 ± 3.50	-0.9 ± 1.85	-3.3 ± 4.25
Bilirubin,Week 20,n=25,23,19,18,16	4.7 ± 9.09	4.3 ± 4.36	3.6 ± 3.58	-1.4 ± 2.20	-3.1 ± 4.67
Bilirubin,Week 24,n=22,21,16,17,16	4.9 ± 6.29	3.0 ± 4.41	4.8 ± 3.60	-1.1 ± 1.80	-1.7 ± 3.34
Bilirubin,Week 28,n=19,18,12,13,14	4.4 ± 5.86	3.7 ± 3.77	3.1 ± 3.18	-0.8 ± 1.92	-3.2 ± 3.72
Bilirubin,Week 32,n=19,15,10,12,13	4.2 ± 4.95	4.0 ± 4.54	2.7 ± 2.91	-0.8 ± 2.53	-3.0 ± 3.74
Bilirubin,Week 36,n=15,12,10,12,13	5.2 ± 4.66	5.3 ± 5.42	2.3 ± 2.91	-0.9 ± 1.88	-2.1 ± 4.91
Bilirubin,Week 40,n=15,11,6,10,10	5.1 ± 4.18	2.9 ± 4.13	2.6 ± 2.07	-1.1 ± 2.02	-1.9 ± 4.18
Bilirubin,Week 44,n=11,11,6,8,9	4.4 ± 6.14	1.8 ± 3.52	2.5 ± 2.17	-0.1 ± 2.03	-1.2 ± 3.23
Bilirubin,Week 48,n=9,8,5,8,5	6.7 ± 6.22	3.8 ± 3.62	2.2 ± 1.79	-1.1 ± 1.96	-1.8 ± 2.49
Bilirubin,Week 52,n=9,5,5,5,4	4.8 ± 5.09	1.6 ± 3.58	5.0 ± 4.36	-1.0 ± 2.00	1.8 ± 6.85
Direct Bilirubin,Week 2,n=38,39,26,24,26	0.1 ± 1.03	-0.1 ± 0.92	0.1 ± 0.82	0.0 ± 0.59	-0.3 ± 0.75
Direct Bilirubin,Week 4,n=37,38,25,23,27	0.3 ± 0.97	0.1 ± 0.73	0.1 ± 0.76	-0.2 ± 0.83	-0.6 ± 1.31
Direct Bilirubin,Week 8,n=34,31,24,22,23	0.2 ± 1.01	0.1 ± 0.72	0.0 ± 0.29	-0.1 ± 0.75	-0.8 ± 1.31
Direct Bilirubin,Week 12,n=32,28,24,22,21	0.3 ± 1.12	0.1 ± 0.66	0.2 ± 0.96	-0.1 ± 0.75	-0.6 ± 1.29
Direct Bilirubin,Week 16,n=28,26,22,19,18	0.3 ± 1.19	0.4 ± 0.98	0.3 ± 0.63	-0.1 ± 0.46	-0.8 ± 1.40
Direct Bilirubin,Week 20,n=25,23,19,18,16	1.4 ± 3.29	0.1 ± 1.12	0.4 ± 0.77	-0.2 ± 0.65	-0.9 ± 1.45
Direct Bilirubin,Week 24,n=22,21,16,17,16	1.0 ± 1.59	0.0 ± 0.89	0.4 ± 0.81	-0.4 ± 0.79	-0.8 ± 1.24
Direct Bilirubin,Week 28,n=19,18,12,13,14	0.7 ± 1.34	-0.1 ± 1.08	0.1 ± 0.90	-0.5 ± 0.88	-1.0 ± 1.52
Direct Bilirubin,Week 32,n=19,15,10,12,13	0.5 ± 1.26	0.3 ± 1.03	0.1 ± 0.32	-0.2 ± 0.58	-1.2 ± 1.54
Direct Bilirubin,Week 36,n=15,12,10,12,13	0.7 ± 1.22	0.3 ± 1.44	-0.1 ± 0.74	-0.2 ± 0.58	-1.2 ± 1.54
Direct Bilirubin,Week 40,n=15,11,6,10,10	0.6 ± 1.18	-0.4 ± 0.81	-0.3 ± 0.71	0.0 ± 0.00	-1.4 ± 1.35
Direct Bilirubin,Week 44,n=11,11,6,8,9	0.8 ± 0.98	-0.4 ± 0.81	0.2 ± 0.41	0.0 ± 0.00	-0.7 ± 1.00
Direct Bilirubin,Week 48,n=9,8,5,8,5	1.2 ± 0.97	-0.3 ± 0.71	-0.6 ± 1.34	0.0 ± 0.00	-1.2 ± 1.10
Direct Bilirubin,Week 52,n=9,5,5,5,4	1.0 ± 1.00	-0.8 ± 1.10	-0.2 ± 1.10	-0.4 ± 0.89	-0.5 ± 1.00
Indirect Bilirubin,Week 2,n=38,39,26,24,26	1.7 ± 2.51	1.6 ± 2.84	1.8 ± 3.18	-1.1 ± 1.75	-0.7 ± 3.19
Indirect Bilirubin,Week 4,n=37,38,25,23,27	2.1 ± 4.93	1.9 ± 2.86	1.8 ± 2.31	-1.6 ± 2.19	-0.9 ± 4.27
Indirect Bilirubin,Week 8,n=34,31,24,22,23	2.8 ± 3.37	2.7 ± 4.37	0.9 ± 2.90	-2.2 ± 2.47	-2.4 ± 4.34
Indirect Bilirubin,Week 12,n=32,28,24,22,21	4.0 ± 7.94	2.7 ± 3.28	2.5 ± 2.87	-1.0 ± 2.63	-2.3 ± 3.79
Indirect Bilirubin,Week 16,n=28,26,22,19,18	2.4 ± 4.29	4.0 ± 3.88	3.6 ± 3.22	-0.8 ± 1.84	-2.5 ± 3.00
Indirect Bilirubin,Week 20,n=25,23,19,18,16	3.3 ± 6.22	4.2 ± 3.66	3.2 ± 3.21	-1.2 ± 2.23	-2.2 ± 3.47
Indirect Bilirubin,Week 24,n=22,21,16,17,16	4.0 ± 5.52	3.0 ± 3.88	4.4 ± 3.03	-0.8 ± 1.64	-0.9 ± 2.62
Indirect Bilirubin,Week 28,n=19,18,12,13,14	3.7 ± 5.05	3.8 ± 3.42	3.0 ± 3.02	-0.3 ± 1.80	-2.2 ± 2.55
Indirect Bilirubin,Week 32,n=19,15,10,12,13	3.7 ± 4.24	3.7 ± 3.77	2.6 ± 2.99	-0.6 ± 2.35	-1.8 ± 2.52
Indirect Bilirubin,Week 36,n=15,12,10,12,13	4.5 ± 4.02	5.0 ± 4.47	2.4 ± 2.63	-0.8 ± 1.66	-0.8 ± 3.83
Indirect Bilirubin,Week 40,n=15,11,6,10,10	4.5 ± 3.94	3.3 ± 3.61	2.9 ± 2.03	-1.1 ± 2.02	-0.5 ± 2.95
Indirect Bilirubin,Week 44,n=11,11,6,8,9	3.5 ± 5.43	2.2 ± 3.03	2.3 ± 2.34	-0.1 ± 2.03	-0.6 ± 2.88
Indirect Bilirubin,Week 48,n=9,8,5,8,5	5.4 ± 5.68	4.0 ± 3.21	2.8 ± 2.28	-1.1 ± 1.96	-0.6 ± 2.19
Indirect Bilirubin,Week 52,n=9,5,5,5,4	3.8 ± 4.52	2.4 ± 2.61	5.2 ± 5.02	-0.6 ± 1.95	2.3 ± 6.13
Creatinine,Week 2,n=38,39,26,24,26	4.96 ± 9.319	4.10 ± 12.030	0.71 ± 5.170	-1.65 ± 6.165	0.28 ± 7.485
Creatinine,,Week 4,n=37,38,25,23,27	4.00 ± 11.061	3.03 ± 12.685	2.56 ± 6.760	-0.64 ± 5.781	0.48 ± 7.222
Creatinine,Week 8,n=34,31,24,22,23	3.26 ± 10.522	1.48 ± 14.285	0.95 ± 6.027	-2.93 ± 7.703	2.43 ± 8.688
Creatinine,,Week 12,n=32,28,24,22,21	2.88 ± 11.590	-0.84 ± 16.780	3.28 ± 6.334	-3.09 ± 7.615	1.46 ± 6.093
Creatinine,,Week 16,n=28,26,22,19,18	3.87 ± 9.387	1.16 ± 12.971	1.27 ± 6.604	-0.14 ± 9.654	3.37 ± 15.068
Creatinine,,Week 20,n=25,23,19,18,16	-0.87 ± 8.652	0.33 ± 9.278	-0.09 ± 5.721	-0.18 ± 6.991	4.73 ± 12.179
Creatinine,Week 24,n=22,21,16,17,16	1.58 ± 9.671	-0.45 ± 20.542	1.86 ± 9.364	-1.14 ± 8.093	2.63 ± 7.834
Creatinine,,Week 28,n=19,18,12,13,14	5.00 ± 12.803	0.46 ± 17.574	-1.33 ± 5.372	-0.28 ± 4.970	4.07 ± 7.431
Creatinine, Week 32,n=19,15,10,12,13	3.88 ± 11.182	-2.52 ± 20.459	-1.33 ± 7.598	0.59 ± 7.911	4.10 ± 7.264
Creatinine,,Week 36,n=15,12,10,12,13	1.09 ± 11.330	-3.82 ± 22.270	0.88 ± 7.151	4.56 ± 9.011	3.62 ± 11.433
Creatinine,,Week 40,n=15,11,6,10,10	4.87 ± 11.617	-1.45 ± 10.674	-0.88 ± 9.831	1.67 ± 9.527	1.55 ± 10.630
Creatinine, Week 44,n=11,11,6,8,9	0.03 ± 14.182	-7.06 ± 19.793	-2.38 ± 7.847	0.23 ± 7.876	3.96 ± 14.656
Creatinine,,Week 48,n=9,8,5,8,5	7.21 ± 14.144	-7.15 ± 26.680	2.80 ± 8.917	1.43 ± 5.646	5.72 ± 18.804
Creatinine,,Week 52,n=9,5,5,5,4	3.56 ± 6.903	-5.10 ± 30.563	4.20 ± 9.195	1.78 ± 9.836	12.23 ± 16.814

No statistical analyses for this end point

Secondary: Part A: Mean Serum concentrations of sirukumab

Top of page

End point title

Part A: Mean Serum concentrations of sirukumab

End point description

Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points. Data was not collected due to early termination of the study

End point type

Secondary

End point timeframe

Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	0 ^[8]	0 ^[9]	0 ^[10]	0 ^[11]	0 ^[12]
Units: Milligrams per milliliter
arithmetic mean (standard deviation)	±	±	±	±	±

Notes
[8] - Data was not collected due to early termination of the study
[9] - Data was not collected due to early termination of the study
[10] - Data was not collected due to early termination of the study
[11] - Data was not collected due to early termination of the study
[12] - Data was not collected due to early termination of the study

No statistical analyses for this end point

Secondary: Part A: Mean Serum anti-sirukumab antibodies

Top of page

End point title

Part A: Mean Serum anti-sirukumab antibodies

End point description

Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points. Data was not collected due to early termination of the study

End point type

Secondary

End point timeframe

Baseline (Week 0) and up to 52 weeks

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	0 ^[13]	0 ^[14]	0 ^[15]	0 ^[16]	0 ^[17]
Units: Micrograms per milliliter
arithmetic mean (standard deviation)	±	±	±	±	±

Notes
[13] - Data was not collected due to early termination of the study
[14] - Data was not collected due to early termination of the study
[15] - Data was not collected due to early termination of the study
[16] - Data was not collected due to early termination of the study
[17] - Data was not collected due to early termination of the study

No statistical analyses for this end point

Secondary: Part A: Change from Baseline in free and total interleukin-6 (IL-6) over time

Top of page

End point title

Part A: Change from Baseline in free and total interleukin-6 (IL-6) over time

End point description

Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.

End point type

Secondary

End point timeframe

Baseline (Week 0) and up to 52 weeks

End point values	PartA:SIR 100 mg SC q2w+6 month Prednisone	PartA:SIR 100 mg SC q2w+3 month Prednisone	PartA:SIR 50 mg SC q4w+6 month Prednisone	PartA:Placebo SC q2w + 6 month Prednisone	PartA:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	0 ^[18]	0 ^[19]	0 ^[20]	0 ^[21]	0 ^[22]
Units: Picograms per milliliter
arithmetic mean (standard deviation)	±	±	±	±	±

Notes
[18] - Data was not collected due to early termination of the study
[19] - Data was not collected due to early termination of the study
[20] - Data was not collected due to early termination of the study
[21] - Data was not collected due to early termination of the study
[22] - Data was not collected due to early termination of the study

No statistical analyses for this end point

Secondary: Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Up to 120 weeks

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Participants
number (not applicable)
All AEs	2	1	1	2	2
All SAEs	0	0	0	0	0
Corticosteroid related AEs	0	0	0	1	1

No statistical analyses for this end point

Secondary: Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who never received 100mg OL Sirukumab in Part B

Top of page

End point title

Part B: Number of participants with AEs, SAEs and corticosteroid related AEs who never received 100mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Up to 120 weeks

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Participants
number (not applicable)
All AEs	0	4	3	2	1
All SAEs	0	0	0	0	0
Corticosteroid related AEs	1	0	1	0	0

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in SBP and DBP for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in SBP and DBP for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Millimeters of mercury
arithmetic mean (standard deviation)
SBP,Week 2,n=1,1,0,1,2	2.0 ± 99999	15.0 ± 99999	99999 ± 99999	0.0 ± 99999	6.5 ± 19.09
SBP,Week 4,n=2,1,1,2,2	5.0 ± 21.21	0.0 ± 99999	6.0 ± 99999	-1.5 ± 3.54	1.5 ± 0.71
SBP,Week 8,n=2,1,1,2,1	14.0 ± 8.49	18.0 ± 99999	-12.0 ± 99999	-11.5 ± 10.61	5.0 ± 99999
SBP,Week 12,n=2,1,1,1,0	7.0 ± 1.41	14.0 ± 99999	8.0 ± 99999	2.0 ± 99999	99999 ± 99999
SBP,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	9.0 ± 99999	99999 ± 99999
SBP,Week 16,n=2,0,0,1,0	0.0 ± 0.00	99999 ± 99999	99999 ± 99999	11.0 ± 99999	99999 ± 99999
SBP,Week 24,n=2,0,0,0,0	8.0 ± 0.00	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
SBP,Week 36,n=2,0,0,0,0	11.0 ± 9.90	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
SBP,Week 38,n=1,0,0,0,0	-6.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
SBP,Week 40,n=1,0,0,0,0	-10.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
SBP,Week follow up,n=2,1,0,1,1	3.0 ± 18.38	-1.0 ± 99999	99999 ± 99999	22.0 ± 99999	12.0 ± 99999
DBP,Week 2,n=1,1,0,1,2	-10.0 ± 99999	-8.0 ± 99999	99999 ± 99999	0.0 ± 99999	7.0 ± 9.90
DBP,Week 4,n=2,1,1,2,2	-3.0 ± 12.73	-15.0 ± 99999	6.0 ± 99999	2.0 ± 5.66	4.5 ± 3.54
DBP,Week 8,n=2,1,1,2,1	3.0 ± 4.24	-5.0 ± 99999	-4.0 ± 99999	4.0 ± 2.83	-1.0 ± 99999
DBP,Week 12,n=2,1,1,1,0	-5.0 ± 7.07	-5.0 ± 99999	1.0 ± 99999	4.0 ± 99999	99999 ± 99999
DBP,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	7.0 ± 99999	99999 ± 99999
DBP,Week 16,n=2,0,0,1,0	-5.0 ± 7.07	99999 ± 99999	99999 ± 99999	15.0 ± 99999	99999 ± 99999
DBP,Week 24,n=2,0,0,0,0	1.0 ± 1.41	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
DBP,Week 36,n=2,0,0,0,0	-2.0 ± 2.83	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
DBP,Week 38,n=1,0,0,0,0	-8.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
DBP,Week 40,n=1,0,0,0,0	-10.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
DBP,Week follow up,n=2,1,0,1,1	-2.0 ± 5.66	-7.0 ± 99999	99999 ± 99999	21.0 ± 99999	3.0 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in SBP and DBP for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in SBP and DBP for participants who never received 100 mg open label Sirukumab in Part B

End point description

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Millimeters of mercury
arithmetic mean (standard deviation)
SBP,Week 4,n=3,3,3,1,2	-2.0 ± 8.49	-23.7 ± 4.73	-6.3 ± 5.51	7.0 ± 25.36	10.0 ± 99999
SBP,Week 8,n=2,1,2,0,2	-1.5 ± 0.71	-32.5 ± 14.85	-6.0 ± 99999	-7.5 ± 17.68	99999 ± 99999
SBP,Week 12,n=1,1,1,1,1	-2.0 ± 99999	-59.0 ± 99999	-4.0 ± 99999	15.0 ± 99999	13.0 ± 99999
SBP,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-8.0 ± 99999	25.0 ± 99999	-8.0 ± 99999
SBP,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	4.0 ± 99999	99999 ± 99999	99999 ± 99999
SBP,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-26.0 ± 99999	99999 ± 99999	99999 ± 99999
SBP,Week follow up,n=5,4,2,3,2	5.0 ± 1.41	-7.4 ± 19.62	-3.3 ± 8.54	-17.5 ± 31.82	10.7 ± 10.07
DBP,Week 4,n=3,3,3,1,2	-11.0 ± 11.31	-8.3 ± 14.29	0.3 ± 4.51	7.7 ± 8.74	-4.0 ± 99999
DBP,Week 8,n=2,1,2,0,2	-6.0 ± 8.49	-9.0 ± 2.83	-10.0 ± 99999	16.5 ± 2.12	99999 ± 99999
DBP,Week 12,n=1,1,1,1,1	-9.0 ± 99999	-22.0 ± 99999	-6.0 ± 99999	15.0 ± 99999	8.0 ± 99999
DBP,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.0 ± 99999	15.0 ± 99999	-17.0 ± 99999
DBP,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-10.0 ± 99999	99999 ± 99999	99999 ± 99999
DBP,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-10.0 ± 99999	99999 ± 99999	99999 ± 99999
DBP,Week follow up,n=5,4,2,3,2	-2.0 ± 4.24	3.4 ± 12.34	-2.8 ± 99999	12.5 ± 10.61	6.0 ± 4.36

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in Pulse Rate for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in Pulse Rate for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: beats per minute
arithmetic mean (standard deviation)
Week 2,n=1,1,0,1,2	4.0 ± 99999	7.0 ± 99999	99999 ± 99999	0.0 ± 99999	4.0 ± 8.49
Week 4,n=2,1,1,2,2	-2.0 ± 8.49	6.0 ± 99999	-10.0 ± 99999	-17.0 ± 2.83	-5.5 ± 9.19
Week 8,n=2,1,1,2,1	0.0 ± 5.66	3.0 ± 999999	4.0 ± 99999	-12.5 ± 9.19	-4.0 ± 99999
Week 12,n=2,1,1,1,0	-2.0 ± 2.83	2.0 ± 999999	4.0 ± 99999	-12.0 ± 99999	99999 ± 99999
Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-24.0 ± 99999	99999 ± 99999
Week 16,n=2,0,0,1,0	2.0 ± 2.83	99999 ± 99999	99999 ± 99999	-14.0 ± 99999	99999 ± 99999
Week 24,n=2,0,0,0,0	5.0 ± 1.41	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=2,0,0,0,0	-2.0 ± 8.49	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 38,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 40,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week follow up,n=2,1,0,1,1	5.0 ± 12.73	-3.0 ± 99999	99999 ± 99999	-22.0 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in Pulse Rate for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in Pulse Rate for participants who never received 100 mg open label Sirukumab in Part B

End point description

Pulse rate was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: beats per minute
arithmetic mean (standard deviation)
Week 4,n=3,3,3,1,2	-1.5 ± 6.36	3.7 ± 1.53	0.3 ± 3.51	-14.7 ± 2.31	-29.0 ± 99999
Week 8,n=2,1,2,0,2	-0.5 ± 0.71	8.0 ± 4.24	4.0 ± 99999	-5.5 ± 2.12	99999 ± 99999
Week 12,n=1,1,1,1,1	99999 ± 99999	11.0 ± 99999	-4.0 ± 99999	4.0 ± 99999	6.0 ± 99999
Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-4.0 ± 99999	-4.0 ± 99999	6.0 ± 99999
Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999	99999 ± 99999
Week follow up,n=5,4,2,3,2	7.5 ± 4.95	1.4 ± 10.11	4.0 ± 99999	-1.5 ± 2.12	-7.7 ± 17.62

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in Temperature for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in Temperature for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Celsius
arithmetic mean (standard deviation)
Week 2,n=1,1,0,1,2	0.20 ± 99999	0.50 ± 99999	99999 ± 99999	-0.40 ± 99999	-0.65 ± 0.071
Week 4,n=2,1,1,2,2	0.15 ± 0.071	-0.50 ± 99999	-0.30 ± 99999	-0.10 ± 0.141	0.30 ± 1.414
Week 8,n=2,1,1,2,1	-0.15 ± 0.212	0.00 ± 99999	0.10 ± 99999	-0.20 ± 0.000	-0.50 ± 99999
Week 12,n=2,1,1,1,0	-0.25 ± 0.071	0.90 ± 99999	0.50 ± 99999	0.00 ± 99999	99999 ± 99999
Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-0.20 ± 99999	99999 ± 99999
Week 16,n=2,0,0,1,0	-0.05 ± 0.071	99999 ± 99999	99999 ± 99999	-0.10 ± 99999	99999 ± 99999
Week 24,n=2,0,0,0,0	-0.42 ± 0.163	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=2,0,0,0,0	-0.25 ± 0.071	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 38,n=1,0,0,0,0	0.00 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 40,n=1,0,0,0,0	0.00 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week follow up,n=2,1,0,1,1	0.15 ± 0.071	0.00 ± 99999	99999 ± 99999	0.50 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in Temperature for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in Temperature for participants who never received 100 mg open label Sirukumab in Part B

End point description

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Celsius
arithmetic mean (standard deviation)
Week 4,n=3,3,3,1,2	0.10 ± 0.283	0.10 ± 0.458	0.07 ± 0.115	0.00 ± 0.300	-0.20 ± 99999
Week 8,n=2,1,2,0,2	0.05 ± 0.354	-0.10 ± 0.566	0.00 ± 99999	-0.10 ± 0.283	99999 ± 99999
Week 12,n=1,1,1,1,1	-0.50 ± 99999	-0.30 ± 99999	0.40 ± 99999	0.00 ± 99999	0.00 ± 99999
Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.20 ± 99999	0.00 ± 99999	-0.10 ± 99999
Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.00 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.00 ± 99999	99999 ± 99999	99999 ± 99999
Week follow up,n=5,4,2,3,2	0.20 ± 0.283	0.06 ± 0.305	0.15 ± 0.265	0.00 ± 0.283	-0.13 ± 0.252

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Giga cells per liter
arithmetic mean (standard deviation)
Eosinophils,Week 2,n=1,1,0,1,2	-0.010 ± 99999	-0.110 ± 99999	99999 ± 99999	0.000 ± 99999	-0.010 ± 0.0141
Eosinophils,Week 4,n=2,1,1,2,2	-0.015 ± 0.0212	-0.210 ± 99999	-0.010 ± 99999	-0.030 ± 0.0283	0.035 ± 0.0495
Eosinophils,Week 8,n=2,1,1,2,1	-0.010 ± 0.0424	-0.180 ± 99999	0.040 ± 99999	-0.120 ± 0.1838	0.045 ± 0.0636
Eosinophils,Week 12,n=2,0,1,1,0	-0.030 ± 0.0000	99999 ± 99999	0.030 ± 99999	-0.160 ± 99999	99999 ± 99999
Eosinophils,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-0.290 ± 99999	99999 ± 99999
Eosinophils,Week 16,n=2,0,0,1,0	0.030 ± 0.0141	99999 ± 99999	99999 ± 99999	-0.270 ± 99999	99999 ± 99999
Eosinophils,Week 24,n=2,0,0,0,0	-0.015 ± 0.0212	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Eosinophils,Week 36,n=2,0,0,0,0	-0.010 ± 0.0566	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Eosinophils,Week 38,n=1,0,0,0,0	0.020 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Eosinophils,Week 40,n=1,0,0,0,0	-0.030 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Leukocytes,Week 2,n=1,1,0,1,2	-0.20 ± 99999	0.30 ± 99999	99999 ± 99999	2.60 ± 99999	-2.30 ± 0.424
Leukocytes,Week 4,n=2,1,1,2,2	0.25 ± 0.778	-0.30 ± 99999	0.20 ± 99999	0.60 ± 1.697	-1.45 ± 0.071
Leukocytes,Week 8,n=2,1,1,2,1	-0.25 ± 1.061	0.00 ± 99999	0.60 ± 99999	0.10 ± 0.000	-0.95 ± 2.333
Leukocytes,Week 12,n=2,0,1,1,0	-0.10 ± 0.990	99999 ± 99999	0.90 ± 99999	-0.60 ± 99999	99999 ± 99999
Leukocytes,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.40 ± 99999	99999 ± 99999
Leukocytes,Week 16,n=2,0,0,1,0	-0.45 ± 0.778	99999 ± 99999	99999 ± 99999	-0.30 ± 99999	99999 ± 99999
Leukocytes,Week 24,n=2,0,0,0,0	-0.20 ± 0.424	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Leukocytes,Week 36,n=2,0,0,0,0	0.65 ± 0.354	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Leukocytes,Week 38,n=1,0,0,0,0	-0.50 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Leukocytes,Week 40,n=1,0,0,0,0	-1.30 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Lymphocytes,Week 2,n=1,1,0,1,2	-0.170 ± 99999	0.000 ± 99999	99999 ± 99999	-0.400 ± 99999	-0.160 ± 0.0990
Lymphocytes,Week 4,n=2,1,1,2,2	0.110 ± 0.0566	-0.340 ± 99999	-0.010 ± 99999	-0.035 ± 0.2051	-0.115 ± 0.5162
Lymphocytes,Week 8,n=2,1,1,2,1	-0.120 ± 0.0283	0.160 ± 99999	0.050 ± 99999	-0.185 ± 0.3323	-0.275 ± 0.4172
Lymphocytes,Week 12,n=2,0,1,1,0	-0.030 ± 0.0283	99999 ± 99999	0.300 ± 99999	-0.190 ± 99999	99999 ± 99999
Lymphocytes,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.490 ± 99999	99999 ± 99999
Lymphocytes,Week 16,n=2,0,0,1,0	-0.230 ± 0.2828	99999 ± 99999	99999 ± 99999	0.540 ± 99999	99999 ± 99999
Lymphocytes,Week 24,n=2,0,0,0,0	-0.320 ± 0.1697	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Lymphocytes,Week 36,n=2,0,0,0,0	0.195 ± 0.1768	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
LymphocytesWeek 38,n=1,0,0,0,0	0.010 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Lymphocytes,Week 40,n=1,0,0,0,0	-0.160 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Neutrophils ,Week 2,n=1,1,0,1,2	-0.040 ± 99999	0.510 ± 99999	99999 ± 99999	3.010 ± 99999	-2.210 ± 0.5233
Neutrophils ,Week 4,n=2,1,1,2,2	0.205 ± 0.5728	0.400 ± 99999	0.230 ± 99999	0.740 ± 1.8950	-1.420 ± 0.4950
Neutrophils ,Week 8,n=2,1,1,2,2	-0.265 ± 0.6435	0.060 ± 99999	0.620 ± 99999	0.485 ± 0.1909	-0.790 ± 1.8385
Neutrophils ,Week 12,n=2,0,1,1,0	0.020 ± 0.8061	99999 ± 99999	0.630 ± 99999	-0.320 ± 99999	99999 ± 99999
Neutrophils ,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.590 ± 99999	99999 ± 99999
Neutrophils ,Week 16,n=2,0,0,1,0	-0.235 ± 0.4879	99999 ± 99999	99999 ± 99999	-0.050 ± 99999	99999 ± 99999
Neutrophils ,Week 24,n=2,0,0,0,0	0.085 ± 0.6859	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Neutrophils ,Week 36,n=2,0,0,0,0	0.540 ± 0.6788	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Neutrophils ,Week 38,n=1,0,0,0,0	-0.460 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Neutrophils,Week 40,n=1,0,0,0,0	-0.770 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Platelets ,Week 2,n=1,1,0,1,2	5.0 ± 99999	4.0 ± 99999	99999 ± 99999	-27.0 ± 99999	-20.5 ± 57.28
Platelets,Week 4,n=2,1,1,2,2	-1.0 ± 4.24	6.0 ± 99999	-1.0 ± 99999	-33.5 ± 30.41	-42.0 ± 11.31
Platelets,Week 8,n=2,1,1,2,1	7.0 ± 11.31	-6.0 ± 99999	2.0 ± 99999	-20.5 ± 28.99	-40.0 ± 0.00
Platelets,Week 12,n=2,0,1,1,0	7.0 ± 7.07	99999 ± 99999	52.0 ± 99999	12.0 ± 99999	99999 ± 99999
Platelets,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-31.0 ± 99999	99999 ± 99999
Platelets,Week 16,n=2,0,0,1,0	2.0 ± 1.41	99999 ± 99999	99999 ± 99999	-97.0 ± 99999	99999 ± 99999
Platelets,Week 24,n=2,0,0,0,0	-18.5 ± 9.19	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Platelets,Week 36,n=2,0,0,0,0	10.0 ± 21.21	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Platelets,Week 38,n=1,0,0,0,0	-15.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Platelets,Week 40,n=1,0,0,0,0	-6.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Giga cells per liter
arithmetic mean (standard deviation)
Eosinophils,Week 4,n=3,3,2,1,2	0.415 ± 0.5869	-0.110 ± 0.1735	-0.013 ± 0.0551	-0.050 ± 0.0849	-0.030 ± 99999
Eosinophils,Week 8,n=2,1,2,0,2	0.330 ± 0.4101	-0.070 ± 0.0707	0.020 ± 99999	0.020 ± 0.2546	99999 ± 99999
Eosinophils,Week 12,n=1,1,1,1,1	0.030 ± 99999	-0.120 ± 99999	-0.120 ± 99999	-0.190 ± 99999	0.070 ± 99999
Eosinophils,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-0.200 ± 99999	-0.180 ± 99999	-0.050 ± 99999
Eosinophils,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.100 ± 99999	99999 ± 99999	99999 ± 99999
Eosinophils,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.240 ± 99999	99999 ± 99999	99999 ± 99999
Leukocytes,Week 4,n=3,3,2,1,2	1.30 ± 0.990	0.40 ± 0.500	0.30 ± 1.229	0.50 ± 0.000	-0.40 ± 99999
Leukocytes,Week 8,n=2,1,2,0,2	0.65 ± 0.071	0.25 ± 0.071	0.10 ± 99999	0.90 ± 0.424	99999 ± 99999
Leukocytes,Week 12,n=1,1,1,1,1	-0.70 ± 99999	-1.30 ± 99999	-1.60 ± 99999	0.80 ± 99999	-1.50 ± 99999
Leukocytes,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-0.50 ± 99999	0.30 ± 99999	-1.30 ± 99999
Leukocytes,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.60 ± 99999	99999 ± 99999	99999 ± 99999
Leukocytes,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-1.10 ± 99999	99999 ± 99999	99999 ± 99999
Lymphocytes,Week 4,n=3,3,2,1,2	0.015 ± 0.2475	0.293 ± 0.2136	0.077 ± 0.2442	0.370 ± 0.0990	-0.960 ± 99999
Lymphocytes,Week 8,n=2,1,2,0,2	-0.180 ± 0.4243	0.470 ± 0.0707	0.090 ± 99999	0.205 ± 0.0495	99999 ± 99999
Lymphocytes,Week 12,n=1,1,1,1,1	-0.610 ± 99999	-0.210 ± 99999	0.140 ± 99999	0.190 ± 99999	0.380 ± 99999
Lymphocytes,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-0.040 ± 99999	0.340 ± 99999	-0.520 ± 99999
Lymphocytes,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.000 ± 99999	99999 ± 99999	99999 ± 99999
Lymphocytes,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.240 ± 99999	99999 ± 99999	99999 ± 99999
Neutrophils ,Week 4,n=3,3,2,1,2	0.815 ± 0.0212	0.183 ± 0.4196	0.333 ± 1.0108	0.180 ± 0.1414	0.390 ± 99999
Neutrophils ,Week 8,n=2,1,2,0,2	0.500 ± 0.8627	-0.205 ± 0.1909	0.010 ± 99999	0.600 ± 0.0283	99999 ± 99999
Neutrophils ,Week 12,n=1,1,1,1,1	-0.140 ± 99999	-0.750 ± 99999	-1.440 ± 99999	0.820 ± 99999	-1.770 ± 99999
Neutrophils ,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-0.220 ± 99999	0.230 ± 99999	-0.210 ± 99999
Neutrophils ,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.350 ± 99999	99999 ± 99999	99999 ± 99999
Neutrophils ,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.420 ± 99999	99999 ± 99999	99999 ± 99999
Platelets,Week 4,n=3,3,2,1,2	-14.0 ± 4.24	15.0 ± 31.43	-6.0 ± 9.64	10.5 ± 3.54	26.0 ± 99999
Platelets,Week 8,n=2,1,2,0,2	31.5 ± 4.95	17.5 ± 23.33	-25.0 ± 99999	10.0 ± 22.63	99999 ± 99999
Platelets,Week 12,n=1,1,1,1,1	14.0 ± 99999	27.0 ± 99999	-20.0 ± 99999	14.0 ± 99999	-8.0 ± 99999
Platelets,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-4.0 ± 99999	15.0 ± 99999	-19.0 ± 99999
Platelets,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-20.0 ± 99999	99999 ± 99999	99999 ± 99999
Platelets,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-16.0 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Grams per liter
arithmetic mean (standard deviation)
MCHC,Week 2,n=1,1,0,1,1	-3.0 ± 99999	-1.0 ± 99999	99999 ± 99999	-3.0 ± 99999	20.0 ± 99999
MCHC,Week 4,n=2,1,0,2,1	-1.5 ± 3.54	1.0 ± 99999	99999 ± 99999	3.5 ± 2.12	23.0 ± 99999
MCHC,Week 8,n=2,1,0,2,1	0.0 ± 12.73	16.0 ± 99999	99999 ± 99999	3.5 ± 14.85	9.0 ± 99999
MCHC,Week 12,n=2,0,0,1,0	-5.5 ± 0.71	99999 ± 99999	99999 ± 99999	19.0 ± 99999	99999 ± 99999
MCHC,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	5.0 ± 99999	99999 ± 99999
MCHC,Week 16,n=2,0,0,1,0	0.0 ± 1.41	99999 ± 99999	99999 ± 99999	11.0 ± 99999	99999 ± 99999
MCHC,Week 24,n=2,0,0,0,0	-3.0 ± 2.83	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
MCHC,Week 36,n=2,0,0,0,0	-4.0 ± 4.24	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
MCHC,Week 38,n=1,0,0,0,0	-3.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
MCHC,Week 40,n=1,0,0,0,0	4.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Hemoglobin,Week 2,n=1,1,0,1,2	-4.0 ± 99999	-2.0 ± 99999	99999 ± 99999	7.0 ± 99999	10.0 ± 4.24
Hemoglobin,Week 4,n=2,1,1,2,2	0.5 ± 0.71	-2.0 ± 99999	-9.0 ± 99999	-0.5 ± 10.61	8.0 ± 8.49
Hemoglobin,Week 8,n=2,1,1,2,1	4.0 ± 1.41	3.0 ± 99999	0.0 ± 99999	-0.5 ± 10.61	9.0 ± 4.24
Hemoglobin,Week 12,n=2,0,1,1,0	1.5 ± 3.54	99999 ± 99999	0.0 ± 99999	-6.0 ± 99999	99999 ± 99999
Hemoglobin,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Hemoglobin,Week 16,n=2,0,0,1,0	0.0 ± 0.00	99999 ± 99999	99999 ± 99999	8.0 ± 99999	99999 ± 99999
Hemoglobin,Week 24,n=2,0,0,0,0	-0.5 ± 7.78	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Hemoglobin,Week 36,n=2,0,0,0,0	-1.5 ± 3.54	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Hemoglobin,Week 38,n=1,0,0,0,0	-3.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Hemoglobin,Week 40,n=1,0,0,0,0	-3.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameters- MCHC and Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Grams per liter
arithmetic mean (standard deviation)
MCHC,Week 4,n=3,3,2,1,2	-7.0 ± 11.31	-18.0 ± 99999	-14.0 ± 4.24	-3.0 ± 1.41	0.0 ± 99999
MCHC,Week 8,n=0,1,2,0,2	8.0 ± 19.80	99999 ± 99999	-8.0 ± 99999	-0.5 ± 16.26	99999 ± 99999
MCHC,Week 12,n=0,1,1,1,1	11.0 ± 99999	99999 ± 99999	-10.0 ± 99999	11.0 ± 99999	21.0 ± 99999
MCHC,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-9.0 ± 99999	-1.0 ± 99999	8.0 ± 99999
MCHC,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-17.0 ± 99999	99999 ± 99999	99999 ± 99999
MCHC,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-15.0 ± 99999	99999 ± 99999	99999 ± 99999
Hemoglobin,Week 4,n=3,3,2,1,2	-5.5 ± 3.54	-4.0 ± 5.29	-6.3 ± 3.51	2.0 ± 9.90	-2.0 ± 99999
Hemoglobin,Week 8,n=2,1,2,0,2	-1.5 ± 10.61	-6.0 ± 14.14	-4.0 ± 99999	4.0 ± 12.73	99999 ± 99999
Hemoglobin,Week 12,n=1,1,1,1,1	5.0 ± 99999	-5.0 ± 99999	-1.0 ± 99999	20.0 ± 99999	8.0 ± 99999
Hemoglobin,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-2.0 ± 99999	19.0 ± 99999	2.0 ± 99999
Hemoglobin,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-4.0 ± 99999	99999 ± 99999	99999 ± 99999
Hemoglobin,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter-Hematocrit for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter-Hematocrit for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Hematocrit,Week 2,n=1,1,0,1,2	-0.0080 ± 99999	-0.0060 ± 99999	99999 ± 99999	0.0250 ± 99999	0.0235 ± 0.01202
Hematocrit,Week 4,n=2,1,1,2,2	0.0030 ± 0.00141	-0.0080 ± 99999	-0.0250 ± 99999	-0.0060 ± 0.03111	0.0105 ± 0.00354
Hematocrit,Week 8,n=2,1,1,2,2	0.0115 ± 0.01909	-0.0110 ± 99999	-0.0030 ± 99999	-0.0040 ± 0.01414	0.0260 ± 0.02546
Hematocrit,Week 12,n=2,0,1,1,0	0.0125 ± 0.01202	99999 ± 99999	-0.0060 ± 99999	-0.0420 ± 99999	99999 ± 99999
Hematocrit,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-0.0080 ± 99999	99999 ± 99999
Hematocrit,Week 16,n=2,0,0,1,0	0.0000 ± 0.00141	99999 ± 99999	99999 ± 99999	0.0080 ± 99999	99999 ± 99999
Hematocrit,Week 24,n=2,0,0,0,0	0.0040 ± 0.02687	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Hematocrit,Week 36,n=2,0,0,0,0	0.0005 ± 0.01626	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Hematocrit,Week 38,n=1,0,0,0,0	-0.0050 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Hematocrit,Week 40,n=1,0,0,0,0	-0.0140 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter-Hematocrit for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter-Hematocrit for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Hematocrit,Week 4,n=3,3,2,1,2	-0.0070 ± 0.00849	-0.0047 ± 0.02570	-0.0057 ± 0.01834	0.0115 ± 0.02616	-0.0040 ± 99999
Hematocrit,Week 8,n=2,1,2,0,2	-0.0120 ± 0.00424	-0.0185 ± 0.04879	0.0000 ± 99999	0.0135 ± 0.01768	99999 ± 99999
Hematocrit,Week 12,n=1,1,1,1,1	0.0030 ± 99999	-0.0120 ± 99999	0.0080 ± 99999	0.0470 ± 99999	-0.0010 ± 99999
Hematocrit,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.0060 ± 99999	0.0610 ± 99999	-0.0030 ± 99999
Hematocrit,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.0100 ± 99999	99999 ± 99999	99999 ± 99999
Hematocrit,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.0280 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Femtoliter
arithmetic mean (standard deviation)
Week 2,n=1,1,0,1,2	-2.0 ± 99999	1.0 ± 99999	99999 ± 99999	0.0 ± 99999	0.5 ± 3.54
Week 4,n=2,1,1,2,2	1.5 ± 0.71	1.0 ± 99999	1.0 ± 99999	-1.5 ± 0.71	0.5 ± 2.12
Week 8,n=2,1,1,2,1	1.5 ± 2.12	-1.0 ± 99999	0.0 ± 99999	-2.5 ± 0.71	2.0 ± 2.83
Week 12,n=2,0,1,1,0	2.5 ± 0.71	99999 ± 99999	0.0 ± 99999	-6.0 ± 99999	99999 ± 99999
Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-5.0 ± 99999	99999 ± 99999
Week 16,n=2,0,0,1,0	0.5 ± 0.71	99999 ± 99999	99999 ± 99999	-4.0 ± 99999	99999 ± 99999
Week 24,n=2,0,0,0,0	1.5 ± 0.71	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=2,0,0,0,0	2.5 ± 2.12	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 38,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 40,n=1,0,0,0,0	-2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Femtoliter
arithmetic mean (standard deviation)
Week 4,n=3,3,2,1,2	2.0 ± 1.41	0.7 ± 1.15	1.3 ± 1.53	0.0 ± 0.00	-3.0 ± 99999
Week 8,n=2,1,2,0,2	1.5 ± 0.71	-0.5 ± 0.71	1.0 ± 99999	0.0 ± 1.41	99999 ± 99999
Week 12,n=1,1,1,1,1	2.0 ± 99999	0.0 ± 99999	2.0 ± 99999	-1.0 ± 99999	1.0 ± 99999
Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	1.0 ± 99999	0.0 ± 99999	2.0 ± 99999
Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	3.0 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	4.0 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Picograms
arithmetic mean (standard deviation)
Week 2,n=1,1,0,1,2	-1.10 ± 99999	0.20 ± 99999	99999 ± 99999	-0.20 ± 99999	0.60 ± 0.990
Week 4,n=2,1,1,2,2	0.30 ± 0.000	0.60 ± 99999	0.20 ± 99999	-0.05 ± 0.354	1.00 ± 1.273
Week 8,n=2,1,1,2,2	0.30 ± 0.424	1.30 ± 99999	0.30 ± 99999	-0.45 ± 0.919	0.70 ± 0.141
Week 12,n=2,1,1,1,0	0.25 ± 0.212	99999 ± 99999	0.30 ± 99999	0.00 ± 99999	99999 ± 99999
Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-0.90 ± 99999	99999 ± 99999
Week 16,n=2,0,0,1,0	0.00 ± 0.00	99999 ± 99999	99999 ± 99999	-0.10 ± 99999	99999 ± 99999
Week 24,n=2,0,0,0,0	0.10 ± 0.141	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=2,0,0,0,0	0.25 ± 0.354	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 38,n=1,0,0,0,0	-0.40 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 40,n=1,0,0,0,0	0.40 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Picograms
arithmetic mean (standard deviation)
Week 4,n=3,3,2,1,2	0.00 ± 0.849	-0.33 ± 0.757	-0.47 ± 0.451	-0.25 ± 0.354	-1.00 ± 99999
Week 8,n=2,1,2,0,2	1.10 ± 2.121	-0.15 ± 0.354	-0.60 ± 99999	0.00 ± 1.273	99999 ± 99999
Week 12,n=1,1,1,1,1	1.80 ± 99999	-0.10 ± 99999	-0.50 ± 99999	0.70 ± 99999	2.20 ± 99999
Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-0.80 ± 99999	-0.20 ± 99999	1.30 ± 99999
Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.80 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.20 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Trillion cells per liter
arithmetic mean (standard deviation)
Week 2,n=1,1,0,1,2	0.00 ± 99999	-0.10 ± 99999	99999 ± 99999	0.30 ± 99999	0.25 ± 0.071
Week 4,n=2,1,1,2,2	0.00 ± 0.000	-0.10 ± 99999	-0.30 ± 99999	0.00 ± 0.283	0.10 ± 0.141
Week 8,n=2,1,1,2,2	0.10 ± 0.141	0.00 ± 99999	0.00 ± 99999	0.05 ± 0.212	0.15 ± 0.071
Week 12,n=2,1,1,1,0	0.10 ± 0.141	99999 ± 99999	0.00 ± 99999	-0.20 ± 99999	99999 ± 99999
Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.10 ± 99999	99999 ± 99999
Week 16,n=2,0,0,1,0	0.00 ± 0.00	99999 ± 99999	99999 ± 99999	-0.20 ± 99999	99999 ± 99999
Week 24,n=2,0,0,0,0	0.00 ± 0.283	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=2,0,0,0,0	-0.05 ± 0.071	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 38,n=1,0,0,0,0	0.00 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 40,n=1,0,0,0,0	0.00 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in hematology parameter- Erythrocytes for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Trillion cells per liter
arithmetic mean (standard deviation)
Week 4,n=3,3,2,1,2	-0.20 ± 0.000	-0.03 ± 0.252	-0.10 ± 0.173	0.10 ± 0.283	0.10 ± 99999
Week 8,n=2,1,2,0,2	-0.20 ± 0.000	-0.15 ± 0.495	0.00 ± 99999	0.10 ± 0.283	99999 ± 99999
Week 12,n=1,1,1,1,1	-0.10 ± 99999	-0.10 ± 99999	0.10 ± 99999	0.60 ± 99999	0.00 ± 99999
Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.10 ± 99999	0.70 ± 99999	-0.10 ± 99999
Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.00 ± 99999	99999 ± 99999	99999 ± 99999
Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.10 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone	PartB:Placebo SC q2w + 12 month Prednisone
Number of subjects analysed	2	1	1	2	2
Units: Millimoles per liter
arithmetic mean (standard deviation)
Calcium,Week 2,n=1,1,0,1,2	0.060 ± 99999	0.000 ± 99999	99999 ± 99999	0.100 ± 99999	0.040 ± 0.0000
Calcium,Week 4,n=2,1,1,2,2	0.070 ± 0.0707	-0.100 ± 99999	-0.080 ± 99999	0.050 ± 0.1273	0.000 ± 0.0566
Calcium,Week 8,n=2,1,1,2,1	0.120 ± 0.0283	-0.140 ± 99999	0.000 ± 99999	-0.020 ± 0.0849	0.020 ± 99999
Calcium,Week 12,n=2,1,1,1,0	0.110 ± 0.0990	99999 ± 99999	0.000 ± 99999	-0.040 ± 99999	99999 ± 99999
Calcium,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.000 ± 99999	99999 ± 99999
Calcium,Week 16,n=2,0,0,1,0	0.000 ± 0.1131	99999 ± 99999	99999 ± 99999	0.140 ± 99999	99999 ± 99999
Calcium,Week 24,n=2,0,0,0,0	0.040 ± 0.0566	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Calcium,Week 36,n=2,0,0,0,0	-0.050 ± 0.0707	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Calcium,Week 38,n=1,0,0,0,0	-0.020 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Calcium,Week 40,n=1,0,0,0,0	-0.020 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Carbon Dioxide,Week 2,n=1,1,0,1,2	3.0 ± 99999	-5.0 ± 99999	99999 ± 99999	-2.0 ± 99999	-1.0 ± 0.00
Carbon Dioxide,Week 4,n=2,1,1,2,2	3.5 ± 3.54	-3.0 ± 99999	2.0 ± 99999	-1.5 ± 2.12	-3.5 ± 2.12
Carbon Dioxide,Week 8,n=2,1,1,2,1	2.5 ± 2.12	-4.0 ± 99999	1.0 ± 99999	-1.0 ± 0.00	-1.0 ± 99999
Carbon Dioxide,Week 12,n=2,1,1,1,0	3.5 ± 2.12	99999 ± 99999	2.0 ± 99999	-3.0 ± 99999	99999 ± 99999
Carbon Dioxide,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	1.0 ± 99999	99999 ± 99999
Carbon Dioxide,Week 16,n=2,0,0,1,0	0.5 ± 0.71	99999 ± 99999	99999 ± 99999	-1.0 ± 99999	99999 ± 99999
Carbon Dioxide,Week 24,n=2,0,0,0,0	3.0 ± 0.00	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Carbon Dioxide,Week 36,n=2,0,0,0,0	1.5 ± 4.95	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Carbon Dioxide,Week 38,n=1,0,0,0,0	1.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Carbon Dioxide,Week 40,n=1,0,0,0,0	-2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Chloride,Week 2,n=1,1,0,1,2	-1.0 ± 99999	2.0 ± 99999	99999 ± 99999	0.0 ± 99999	1.0 ± 1.41
Chloride,Week 4,n=2,1,1,2,2	-2.5 ± 0.71	1.0 ± 99999	6.0 ± 99999	0.5 ± 2.12	1.5 ± 0.71
Chloride,Week 8,n=2,1,1,2,1	-3.0 ± 1.41	0.0 ± 99999	2.0 ± 99999	1.0 ± 1.41	3.0 ± 99999
Chloride,Week 12,n=2,1,1,1,0	-2.5 ± 0.71	99999 ± 99999	-1.0 ± 99999	1.0 ± 99999	99999 ± 99999
Chloride,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	1.0 ± 99999	99999 ± 99999
Chloride,Week 16,n=2,0,0,1,0	-1.0 ± 0.00	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Chloride,Week 24,n=2,0,0,0,0	-2.0 ± 1.41	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Chloride,Week 36,n=2,0,0,0,0	0.5 ± 0.71	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Chloride,Week 38,n=1,0,0,0,0	-1.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Chloride,Week 40,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Glucose,Week 2,n=1,1,0,1,2	0.80 ± 99999	0.20 ± 99999	99999 ± 99999	1.30 ± 99999	1.25 ± 1.202
Glucose,Week 4,n=2,1,1,2,2	0.95 ± 1.202	0.40 ± 99999	-0.70 ± 99999	-0.05 ± 2.192	-0.05 ± 0.212
Glucose,Week 8,n=2,1,1,2,1	0.70 ± 0.424	0.00 ± 99999	0.10 ± 99999	0.30 ± 1.414	0.20 ± 99999
Glucose,Week 12,n=2,1,1,1,0	0.60 ± 0.566	0.00 ± 99999	0.00 ± 99999	-0.10 ± 99999	99999 ± 99999
Glucose,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-0.10 ± 99999	99999 ± 99999
Glucose,Week 16,n=2,0,0,1,0	0.55 ± 0.071	99999 ± 99999	99999 ± 99999	-0.20 ± 99999	99999 ± 99999
Glucose,Week 24,n=2,0,0,0,0	0.65 ± 0.354	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Glucose,Week 36,n=2,0,0,0,0	0.35 ± 0.071	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Glucose,Week 38,n=1,0,0,0,0	0.50 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Glucose,Week 40,n=1,0,0,0,0	3.60 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Phosphate,Week 2,n=1,1,0,1,2	0.050 ± 99999	-0.100 ± 99999	99999 ± 99999	-0.300 ± 99999	0.000 ± 0.0707
Phosphate,Week 4,n=2,1,1,2,2	-0.125 ± 0.1768	-0.250 ± 99999	0.000 ± 99999	0.050 ± 0.2828	-0.050 ± 0.1414
Phosphate,Week 8,n=2,1,1,2,1	0.025 ± 0.1061	-0.200 ± 99999	0.150 ± 99999	-0.075 ± 0.3182	-0.050 ± 99999
Phosphate,Week 12,n=2,1,1,1,0	-0.025 ± 0.1768	99999 ± 99999	0.050 ± 99999	0.200 ± 99999	99999 ± 99999
Phosphate,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.250 ± 99999	99999 ± 99999
Phosphate,Week 16,n=2,0,0,1,0	-0.050 ± 0.0707	99999 ± 99999	99999 ± 99999	0.300 ± 99999	99999 ± 99999
Phosphate,Week 24,n=2,0,0,0,0	0.050 ± 0.0000	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Phosphate,Week 36,n=2,0,0,0,0	-0.025 ± 0.0354	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Phosphate,Week 38,n=1,0,0,0,0	0.000 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Phosphate,Week 40,n=1,0,0,0,0	0.000 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Potassium,Week 2,n=1,1,0,1,2	0.10 ± 99999	-0.20 ± 99999	99999 ± 99999	0.00 ± 99999	0.10 ± 0.283
Potassium,Week 4,n=2,1,1,2,2	0.20 ± 0.283	-0.20 ± 99999	0.20 ± 99999	-0.30 ± 0.141	0.00 ± 0.141
Potassium,Week 8,n=2,1,1,2,1	0.10 ± 0.424	0.00 ± 99999	0.50 ± 99999	-0.30 ± 0.424	0.10 ± 99999
Potassium,Week 12,n=2,1,1,1,0	0.25 ± 0.636	99999 ± 99999	0.30 ± 99999	0.10 ± 99999	99999 ± 99999
Potassium,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.00 ± 99999	99999 ± 99999
Potassium,Week 16,n=2,0,0,1,0	0.00 ± 0.141	99999 ± 99999	99999 ± 99999	-0.10 ± 99999	99999 ± 99999
Potassium,Week 24,n=2,0,0,0,0	0.40 ± 0.283	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Potassium,Week 36,n=2,0,0,0,0	0.20 ± 0.424	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Potassium,Week 38,n=1,0,0,0,0	0.00 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Potassium,Week 40,n=1,0,0,0,0	-0.30 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Sodium,Week 2,n=1,1,0,1,2	0.0 ± 99999	-2.0 ± 99999	99999 ± 99999	-2.0 ± 99999	1.0 ± 0.00
Sodium,Week 4,n=2,1,1,2,2	-0.5 ± 0.71	-1.0 ± 99999	3.0 ± 99999	0.5 ± 4.95	0.5 ± 0.71
Sodium,Week 8,n=2,1,1,2,1	-2.0 ± 1.41	-1.0 ± 99999	0.0 ± 99999	-0.5 ± 3.54	2.0 ± 99999
Sodium,Week 12,n=2,1,1,1,0	-1.0 ± 1.41	99999 ± 99999	-2.0 ± 99999	2.0 ± 99999	99999 ± 99999
Sodium,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999
Sodium,Week 16,n=2,0,0,1,0	-1.5 ± 0.71	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Sodium,Week 24,n=2,0,0,0,0	-0.5 ± 0.71	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Sodium,Week 36,n=2,0,0,0,0	2.0 ± 0.00	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Sodium,Week 38,n=1,0,0,0,0	-1.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Sodium,Week 40,n=1,0,0,0,0	2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Urea,Week 2,n=1,1,0,1,2	-1.00 ± 99999	-2.50 ± 99999	99999 ± 99999	0.50 ± 99999	0.75 ± 0.354
Urea,Week 4,n=2,1,1,2,2	1.25 ± 0.354	-1.00 ± 99999	1.50 ± 99999	1.50 ± 0.707	0.25 ± 0.354
Urea,Week 8,n=2,1,1,2,1	2.00 ± 2.121	-2.00 ± 99999	3.00 ± 99999	-0.25 ± 0.354	0.50 ± 99999
Urea,Week 12,n=2,1,1,1,0	-0.50 ± 2.121	99999 ± 99999	1.50 ± 99999	0.00 ± 99999	99999 ± 99999
Urea,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	1.00 ± 99999	99999 ± 99999
Urea,Week 16,n=2,0,0,1,0	1.25 ± 1.768	99999 ± 99999	99999 ± 99999	1.50 ± 99999	99999 ± 99999
Urea,Week 24,n=2,0,0,0,0	0.00 ± 0.000	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Urea,Week 36,n=2,0,0,0,0	0.00 ± 0.707	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Urea,Week 38,n=1,0,0,0,0	1.50 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Urea,Week 40,n=1,0,0,0,0	1.50 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month Prednisone	PartB:SIR 100 mg SC q2w+6 month Prednisone	PartB:SIR 100 mg SC q2w+3 month Prednisone	PartB:SIR 50 mg SC q4w+6 month Prednisone	PartB:Placebo SC q2w + 6 month Prednisone
Number of subjects analysed	2	6	4	3	3
Units: Millimoles per liter
arithmetic mean (standard deviation)
Calcium,Week 4,n=3,3,2,1,2	-0.040 ± 0.0566	0.067 ± 0.0643	-0.093 ± 0.0462	0.060 ± 0.1414	0.120 ± 99999
Calcium,Week 8,n=2,1,2,0,2	0.020 ± 0.0000	0.010 ± 0.0707	-0.060 ± 99999	0.050 ± 0.0707	99999 ± 99999
Calcium,Week 12,n=1,1,1,1,1	0.000 ± 99999	0.020 ± 99999	0.040 ± 99999	0.160 ± 99999	0.000 ± 99999
Calcium,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.040 ± 99999	0.180 ± 99999	0.060 ± 99999
Calcium,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.040 ± 99999	99999 ± 99999	99999 ± 99999
Calcium,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.020 ± 99999	99999 ± 99999	99999 ± 99999
Carbon Dioxide,Week 4,n=3,3,2,1,2	-3.0 ± 0.00	0.0 ± 2.00	-2.7 ± 1.15	0.0 ± 2.83	-1.0 ± 99999
Carbon Dioxide,Week 8,n=2,1,2,0,2	-1.5 ± 0.71	-0.5 ± 0.71	-4.0 ± 99999	0.5 ± 3.54	99999 ± 99999
Carbon Dioxide,Week 12,n=1,1,1,1,1	-3.0 ± 99999	1.0 ± 99999	-2.0 ± 99999	0.0 ± 99999	0.0 ± 99999
Carbon Dioxide,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.0 ± 99999	1.0 ± 99999	0.0 ± 99999
Carbon Dioxide,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	1.0 ± 99999	99999 ± 99999	99999 ± 99999
Carbon Dioxide,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-2.0 ± 99999	99999 ± 99999	99999 ± 99999
Chloride,Week 4,n=3,3,2,1,2	0.5 ± 0.71	0.7 ± 1.15	0.3 ± 3.06	-2.5 ± 4.95	-4.0 ± 99999
Chloride,Week 8,n=2,1,2,0,2	0.5 ± 2.12	-2.0 ± 0.00	-1.0 ± 99999	-2.5 ± 2.12	99999 ± 99999
Chloride,Week 12,n=1,1,1,1,1	-2.0 ± 99999	-2.0 ± 99999	0.0 ± 99999	-4.0 ± 99999	-2.0 ± 99999
Chloride,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	1.0 ± 99999	-5.0 ± 99999	-1.0 ± 99999
Chloride,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	1.0 ± 99999	99999 ± 99999	99999 ± 99999
Chloride,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999	99999 ± 99999
Glucose,Week 4,n=3,3,2,1,2	-0.40 ± 0.707	-0.10 ± 0.608	0.33 ± 1.115	-0.80 ± 0.849	0.70 ± 99999
Glucose,Week 8,n=2,1,2,0,2	0.55 ± 0.354	0.15 ± 1.061	0.60 ± 99999	-0.85 ± 0.071	99999 ± 99999
Glucose,Week 12,n=1,1,1,1,1	0.20 ± 99999	0.00 ± 99999	2.80 ± 99999	0.30 ± 99999	-0.50 ± 99999
Glucose,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	1.40 ± 99999	0.30 ± 99999	2.10 ± 99999
Glucose,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	1.10 ± 99999	99999 ± 99999	99999 ± 99999
Glucose,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	2.10 ± 99999	99999 ± 99999	99999 ± 99999
Phosphate,Week 4,n=3,3,2,1,2	-0.025 ± 0.1061	0.050 ± 0.2646	-0.033 ± 0.1155	-0.125 ± 0.1768	0.050 ± 99999
Phosphate,Week 8,n=2,1,2,0,2	-0.075 ± 0.0354	0.150 ± 0.1414	-0.100 ± 99999	-0.250 ± 0.2121	99999 ± 99999
Phosphate,Week 12,n=1,1,1,1,1	-0.100 ± 99999	0.050 ± 99999	-0.250 ± 99999	0.000 ± 99999	0.250 ± 99999
Phosphate,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.100 ± 99999	0.000 ± 99999	0.000 ± 99999
Phosphate,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.050 ± 99999	99999 ± 99999	99999 ± 99999
Phosphate,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.150 ± 99999	99999 ± 99999	99999 ± 99999
Potassium,Week 4,n=3,3,2,1,2	-0.10 ± 0.141	-0.27 ± 0.289	0.03 ± 0.321	0.10 ± 0.141	0.40 ± 99999
Potassium,Week 8,n=2,1,2,0,2	-0.10 ± 0.283	-0.25 ± 0.212	-0.30 ± 99999	0.00 ± 0.424	99999 ± 99999
Potassium,Week 12,n=1,1,1,1,1	-0.40 ± 99999	-0.20 ± 99999	-0.20 ± 99999	0.40 ± 99999	0.00 ± 99999
Potassium,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-0.10 ± 99999	-0.10 ± 99999	-0.20 ± 99999
Potassium,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.10 ± 99999	99999 ± 99999	99999 ± 99999
Potassium,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.20 ± 99999	99999 ± 99999	99999 ± 99999
Sodium,Week 4,n=3,3,2,1,2	-1.0 ± 1.41	0.3 ± 1.53	-1.0 ± 2.65	-3.0 ± 2.83	-3.0 ± 99999
Sodium,Week 8,n=2,1,2,0,2	-1.0 ± 1.41	-2.5 ± 0.71	2.0 ± 99999	-3.5 ± 3.54	99999 ± 99999
Sodium,Week 12,n=1,1,1,1,1	-4.0 ± 99999	-2.0 ± 99999	1.0 ± 99999	-4.0 ± 99999	0.0 ± 99999
Sodium,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.0 ± 99999	-4.0 ± 99999	0.0 ± 99999
Sodium,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	3.0 ± 99999	99999 ± 99999	99999 ± 99999
Sodium,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	1.0 ± 99999	99999 ± 99999	99999 ± 99999
Urea,Week 4,n=3,3,2,1,2	-0.25 ± 1.061	-0.83 ± 0.577	-0.50 ± 1.323	-0.50 ± 0.707	0.00 ± 99999
Urea,Week 8,n=2,1,2,0,2	0.50 ± 0.707	-0.50 ± 0.707	0.00 ± 99999	-0.75 ± 0.354	99999 ± 99999
Urea,Week 12,n=1,1,1,1,1	-2.50 ± 99999	-0.50 ± 99999	-1.50 ± 99999	0.00 ± 99999	-1.00 ± 99999
Urea,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	0.00 ± 99999	-0.50 ± 99999	0.50 ± 99999
Urea,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-0.50 ± 99999	99999 ± 99999	99999 ± 99999
Urea,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-1.00 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Grams per liter
arithmetic mean (standard deviation)
Albumin,Week 2,n=1,1,0,1,2	-1.0 ± 99999	99999 ± 99999	-1.0 ± 99999	5.0 ± 99999	3.5 ± 0.71
Albumin,Week 4,n=2,1,1,2,2	0.0 ± 1.41	-1.0 ± 99999	0.0 ± 99999	0.0 ± 2.83	3.0 ± 1.41
Albumin,Week 8,n=2,1,1,2,1	1.0 ± 2.83	0.0 ± 99999	0.0 ± 99999	-2.0 ± 2.83	2.0 ± 99999
Albumin,Week 12,n=2,0,1,1,0	1.0 ± 0.00	1.0 ± 99999	99999 ± 99999	-4.0 ± 99999	99999 ± 99999
Albumin,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Albumin,Week 16,n=2,0,0,1,0	-0.5 ± 2.12	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999
Albumin,Week 24,n=2,0,0,0,0	-0.5 ± 3.54	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Albumin,Week 36,n=2,0,0,0,0	-1.0 ± 2.83	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Albumin,Week 38,n=1,0,0,0,0	-2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Albumin,Week 40,n=1,0,0,0,0	-2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Protein,Week 2,n=1,1,0,1,2	0.0 ± 99999	99999 ± 99999	-1.0 ± 99999	8.0 ± 99999	1.5 ± 2.12
Protein,Week 4,n=2,1,1,2,2	1.0 ± 1.41	-2.0 ± 99999	0.0 ± 99999	-0.5 ± 4.95	-0.5 ± 2.12
Protein,Week 8,n=2,1,1,2,1	3.0 ± 1.41	2.0 ± 99999	0.0 ± 99999	-2.5 ± 4.95	0.0 ± 99999
Protein,Week 12,n=2,0,1,1,0	2.5 ± 2.12	2.0 ± 99999	99999 ± 99999	-4.0 ± 99999	99999 ± 99999
Protein,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-5.0 ± 99999	99999 ± 99999
Protein,Week 16,n=2,0,0,1,0	1.0 ± 1.41	99999 ± 99999	99999 ± 99999	-2.0 ± 99999	99999 ± 99999
Protein,Week 24,n=2,0,0,0,0	0.5 ± 3.54	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Protein,Week 36,n=2,0,0,0,0	1.5 ± 0.71	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Protein,Week 38,n=1,0,0,0,0	1.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Protein,Week 40,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters: Albumin and Protein for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: Grams per liter
arithmetic mean (standard deviation)
Albumin,Week 4,n=3,3,2,1,2	-2.5 ± 0.71	-0.3 ± 1.53	-1.3 ± 0.58	1.0 ± 1.41	0.0 ± 99999
Albumin,Week 8,n=2,1,2,0,2	-1.5 ± 0.71	1.5 ± 2.12	-2.0 ± 99999	1.0 ± 2.83	99999 ± 99999
Albumin,Week 12,n=1,1,1,1,1	0.0 ± 99999	3.0 ± 99999	-1.0 ± 99999	5.0 ± 99999	3.0 ± 99999
Albumin,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-2.0 ± 99999	5.0 ± 99999	0.0 ± 99999
Albumin,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-1.0 ± 99999	99999 ± 99999	99999 ± 99999
Albumin,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-2.0 ± 99999	99999 ± 99999	99999 ± 99999
Protein,Week 4,n=3,3,2,1,2	-5.0 ± 2.83	-0.3 ± 3.21	-2.7 ± 1.53	1.0 ± 5.66	0.0 ± 99999
Protein,Week 8,n=2,1,2,0,2	-1.5 ± 3.54	1.5 ± 3.54	-2.0 ± 99999	2.5 ± 4.95	99999 ± 99999
Protein,Week 12,n=1,1,1,1,1	2.0 ± 99999	3.0 ± 99999	-2.0 ± 99999	9.0 ± 99999	1.0 ± 99999
Protein,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-2.0 ± 99999	12.0 ± 99999	-1.0 ± 99999
Protein,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-1.0 ± 99999	99999 ± 99999	99999 ± 99999
Protein,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-2.0 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: International units per liter
arithmetic mean (standard deviation)
ALT,Week 2,n=1,1,0,1,2	1.0 ± 99999	99999 ± 99999	4.0 ± 99999	3.0 ± 99999	72.5 ± 101.12
ALT,Week 4,n=2,1,1,2,2	-1.5 ± 3.54	0.0 ± 99999	4.0 ± 99999	4.0 ± 9.90	51.5 ± 64.35
ALT,Week 8,n=2,1,1,2,2	2.5 ± 4.95	1.0 ± 99999	2.0 ± 99999	4.5 ± 7.78	31.5 ± 24.75
ALT,Week 12,n=2,0,1,1,0	-3.0 ± 7.07	4.0 ± 99999	99999 ± 99999	-3.0 ± 99999	99999 ± 99999
ALT,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999
ALT,Week 16,n=2,0,0,1,0	-1.0 ± 2.83	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999
ALT,Week 24,n=2,0,0,0,0	-2.5 ± 6.36	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
ALT,Week 36,n=2,0,0,0,0	-4.5 ± 9.19	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
ALT,Week 38,n=1,0,0,0,0	-9.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
ALT,Week 40,n=1,0,0,0,0	-9.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
ALP,Week 2,n=1,1,0,1,2	7.0 ± 99999	99999 ± 99999	-2.0 ± 99999	-17.0 ± 99999	-5.0 ± 5.66
ALP,Week 4,n=2,1,1,2,2	5.5 ± 0.71	-4.0 ± 99999	-9.0 ± 99999	-9.0 ± 14.14	-7.0 ± 5.66
ALP,Week 8,n=2,1,1,2,2	7.0 ± 1.41	-3.0 ± 99999	-16.0 ± 99999	-4.5 ± 26.16	-12.0 ± 5.66
ALP,Week 12,n=2,0,1,1,0	5.0 ± 1.41	2.0 ± 99999	99999 ± 99999	8.0 ± 99999	99999 ± 99999
ALP,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	-15.0 ± 99999	99999 ± 99999
ALP,Week 16,n=2,0,0,1,0	-0.5 ± 0.71	99999 ± 99999	99999 ± 99999	-9.0 ± 99999	99999 ± 99999
ALP,Week 24,n=2,0,0,0,0	2.5 ± 2.12	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
ALP,Week 36,n=2,0,0,0,0	2.0 ± 5.66	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
ALP,Week 38,n=1,0,0,0,0	7.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
ALP,Week 40,n=1,0,0,0,0	18.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
AST,Week 2,n=1,1,0,1,2	0.0 ± 99999	99999 ± 99999	0.0 ± 99999	3.0 ± 99999	44.5 ± 57.28
AST,Week 4,n=2,1,1,2,2	-4.5 ± 0.71	0.0 ± 99999	0.0 ± 99999	-0.5 ± 3.54	23.0 ± 25.46
AST,Week 8,n=2,1,1,2,2	1.5 ± 0.71	-3.0 ± 99999	-2.0 ± 99999	2.0 ± 4.24	14.0 ± 5.66
AST,Week 12,n=2,0,1,1,0	-4.0 ± 1.41	-1.0 ± 99999	99999 ± 99999	-2.0 ± 99999	99999 ± 99999
AST,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
AST,Week 16,n=2,0,0,1,0	-3.0 ± 2.83	99999 ± 99999	99999 ± 99999	1.0 ± 99999	99999 ± 99999
AST,Week 24,n=2,0,0,0,0	-3.5 ± 2.12	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
AST,Week 36,n=2,0,0,0,0	-4.5 ± 4.95	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
AST,Week 38,n=1,0,0,0,0	-7.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
AST,Week 40,n=1,0,0,0,0	-7.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters: ALT, ALP and AST for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: International units per liter
arithmetic mean (standard deviation)
ALT,Week 4,n=3,3,2,1,2	1.0 ± 0.00	2.3 ± 1.15	2.7 ± 7.23	-8.0 ± 4.24	103.0 ± 99999
ALT,Week 8,n=2,1,2,0,2	-1.5 ± 3.54	9.0 ± 7.07	13.0 ± 99999	-9.5 ± 9.19	99999 ± 99999
ALT,Week 12,n=1,1,1,1,1	2.0 ± 99999	3.0 ± 99999	8.0 ± 99999	-4.0 ± 99999	0.0 ± 99999
ALT,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-5.0 ± 99999	-6.0 ± 99999	1.0 ± 99999
ALT,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999	99999 ± 99999
ALT,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-4.0 ± 99999	99999 ± 99999	99999 ± 99999
ALP,Week 4,n=3,3,2,1,2	0.0 ± 14.14	-0.7 ± 3.79	0.0 ± 4.36	0.5 ± 3.54	81.0 ± 99999
ALP,Week 8,n=2,1,2,0,2	-3.0 ± 0.00	1.5 ± 2.12	-1.0 ± 99999	-1.0 ± 4.24	99999 ± 99999
ALP,Week 12,n=1,1,1,1,1	-10.0 ± 99999	-1.0 ± 99999	0.0 ± 99999	17.0 ± 99999	-11.0 ± 99999
ALP,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	4.0 ± 99999	3.0 ± 99999	-10.0 ± 99999
ALP,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999	99999 ± 99999
ALP,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	4.0 ± 99999	99999 ± 99999	99999 ± 99999
AST,Week 4,n=3,3,2,1,2	-1.5 ± 3.54	0.7 ± 1.53	2.0 ± 3.00	-5.0 ± 1.41	24.0 ± 99999
AST,Week 8,n=2,1,2,0,2	0.0 ± 5.66	10.5 ± 9.19	7.0 ± 99999	-6.0 ± 2.83	99999 ± 99999
AST,Week 12,n=1,1,1,1,1	2.0 ± 99999	1.0 ± 99999	-1.0 ± 99999	2.0 ± 99999	0.0 ± 99999
AST,Week 16,n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	-4.0 ± 99999	0.0 ± 99999	2.0 ± 99999
AST,Week 24,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-1.0 ± 99999	99999 ± 99999	99999 ± 99999
AST,Week 36,n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	-3.0 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin,Week 2,n=1,1,0,1,2	0.0 ± 99999	99999 ± 99999	0.0 ± 99999	2.0 ± 99999	-1.0 ± 1.41
Bilirubin,Week 4,n=2,1,1,2,2	5.0 ± 1.41	0.0 ± 99999	-2.0 ± 99999	1.0 ± 1.41	1.0 ± 1.41
Bilirubin,Week 8,n=2,1,1,2,2	-1.0 ± 4.24	2.0 ± 99999	0.0 ± 99999	1.0 ± 4.24	2.0 ± 0.00
Bilirubin,Week 12,n=2,0,1,1,0	0.0 ± 8.49	0.0 ± 99999	99999 ± 99999	-2.0 ± 99999	99999 ± 99999
Bilirubin,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Bilirubin,Week 16,n=2,0,0,1,0	5.0 ± 4.24	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999
Bilirubin,Week 24,n=2,0,0,0,0	-2.0 ± 5.66	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Bilirubin,Week 36,n=2,0,0,0,0	1.0 ± 7.07	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Bilirubin,Week 38,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Bilirubin,Week 40,n=1,0,0,0,0	2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Direct Bilirubin,Week 2,n=1,1,0,1,2	0.0 ± 99999	99999 ± 99999	0.0 ± 99999	2.0 ± 99999	0.0 ± 0.00
Direct Bilirubin,Week 4,n=2,1,1,2,2	1.0 ± 1.41	0.0 ± 99999	0.0 ± 99999	1.0 ± 1.41	0.0 ± 0.00
Direct Bilirubin,Week 8,n=2,1,1,2,1	0.0 ± 2.83	0.0 ± 99999	0.0 ± 99999	1.0 ± 1.41	0.0 ± 99999
Direct Bilirubin,Week 12,n=2,0,1,1,0	0.0 ± 2.83	0.0 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Direct Bilirubin,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Direct Bilirubin,Week 16,n=2,0,0,1,0	1.0 ± 1.41	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Direct Bilirubin,Week 24,n=2,0,0,0,0	0.0 ± 0.00	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Direct Bilirubin,Week 36,n=2,0,0,0,0	-1.0 ± 1.41	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Direct Bilirubin,Week 38,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Direct Bilirubin,Week 40,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 2,n=1,1,0,1,2	0.0 ± 99999	99999 ± 99999	0.0 ± 99999	0.0 ± 99999	-1.0 ± 1.41
Indirect Bilirubin,Week 4,n=2,1,1,2,2	4.0 ± 0.00	0.0 ± 99999	-2.0 ± 99999	0.0 ± 0.00	1.0 ± 1.41
Indirect Bilirubin,Week 8,n=2,1,1,2,1	-1.0 ± 1.41	2.0 ± 99999	0.0 ± 99999	0.0 ± 2.83	2.0 ± 99999
Indirect Bilirubin,Week 12,n=2,0,1,1,0	0.0 ± 5.66	0.0 ± 99999	99999 ± 99999	-2.0 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.0 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 16,n=2,0,0,1,0	4.0 ± 5.66	99999 ± 99999	99999 ± 99999	2.0 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 24,n=2,0,0,0,0	-2.0 ± 5.66	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 36,n=2,0,0,0,0	2.0 ± 8.49	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 38,n=1,0,0,0,0	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 40,n=1,0,0,0,0	2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Creatinine,Week 2,n=1,1,0,1,2	-3.50 ± 99999	99999 ± 99999	-6.20 ± 99999	1.80 ± 99999	3.10 ± 1.838
Creatinine,Week 4,n=2,1,1,2,2	-11.05 ± 9.405	2.70 ± 99999	-12.40 ± 99999	-1.30 ± 0.566	2.20 ± 4.384
Creatinine,Week 8,n=2,1,1,2,1	-8.40 ± 6.930	9.70 ± 99999	-8.00 ± 99999	0.45 ± 5.728	0.00 ± 99999
Creatinine,Week 12,n=2,0,1,1,0	-11.90 ± 11.879	4.40 ± 99999	99999 ± 99999	-0.90 ± 99999	99999 ± 99999
Creatinine,Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.80 ± 99999	99999 ± 99999
Creatinine,Week 16,n=2,0,0,1,0	-12.80 ± 5.657	99999 ± 99999	99999 ± 99999	4.40 ± 99999	99999 ± 99999
Creatinine,Week 24,n=2,0,0,0,0	-9.75 ± 12.516	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Creatinine,Week 36,n=2,0,0,0,0	-15.05 ± 9.970	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Creatinine,Week 38,n=1,0,0,0,0	-19.40 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Creatinine,Week 40,n=1,0,0,0,0	-20.30 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for participants who never received 100 mg open label Sirukumab in Part B

End point description

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

End point values	PartBSIR 100 mg SC q2w+6 month prednisone	PartBSIR 100 mg SC q2w+3 month prednisone	PartBSIR 50 mg SC q4w+6 month prednisone	PartBPlacebo SC q2w + 6 month prednisone	PartBPlacebo SC q2w + 12 month prednisone
Number of subjects analysed	6	4	3	3	2
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin,Week 4,n=3,3,2,1,2	0.7 ± 3.06	1.3 ± 3.06	-5.0 ± 1.41	0.0 ± 99999	-8.0 ± 2.83
Bilirubin,Week 8,n=2,1,2,0,2	3.0 ± 4.24	2.0 ± 99999	-4.0 ± 2.83	99999 ± 99999	-6.0 ± 5.66
Bilirubin,Week 12,n=1,1,1,1,1	4.0 ± 99999	-2.0 ± 99999	2.0 ± 99999	4.0 ± 99999	-8.0 ± 99999
Bilirubin,Week 16,n=0,1,1,1,0	99999 ± 99999	-2.0 ± 99999	-2.0 ± 99999	4.0 ± 99999	99999 ± 99999
Bilirubin,Week 24,n=0,1,0,0,0	99999 ± 99999	-2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Bilirubin,Week 36,n=0,1,0,0,0	99999 ± 99999	-4.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Direct Bilirubin,Week 4,n=3,3,2,1,2	0.0 ± 0.00	0.0 ± 0.00	0.0 ± 0.00	0.0 ± 99999	-2.0 ± 0.00
Direct Bilirubin,Week 8,n=2,1,2,0,2	1.0 ± 1.41	2.0 ± 99999	0.0 ± 0.00	99999 ± 99999	-2.0 ± 0.00
Direct Bilirubin,Week 12,n=1,1,1,1,1	2.0 ± 99999	2.0 ± 99999	0.0 ± 99999	0.0 ± 99999	-2.0 ± 99999
Direct Bilirubin,Week 16,n=0,1,1,1,0	99999 ± 99999	0.0 ± 99999	0.0 ± 99999	0.0 ± 99999	99999 ± 99999
Direct Bilirubin,Week 24,n=0,1,0,0,0	99999 ± 99999	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Direct Bilirubin,Week 36,n=0,1,0,0,0	99999 ± 99999	0.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 4,n=3,3,2,1,2	0.7 ± 3.06	1.3 ± 3.06	-5.0 ± 1.41	0.0 ± 99999	-6.0 ± 2.83
Indirect Bilirubin,Week 8,n=2,1,2,0,2	2.0 ± 2.83	0.0 ± 99999	-4.0 ± 2.83	99999 ± 99999	-4.0 ± 5.66
Indirect Bilirubin,Week 12,n=1,1,1,1,1	2.0 ± 99999	-4.0 ± 99999	2.0 ± 99999	4.0 ± 99999	-6.0 ± 99999
Indirect Bilirubin,Week 16,n=0,1,1,1,0	99999 ± 99999	-2.0 ± 99999	-2.0 ± 99999	4.0 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 24,n=0,1,0,0,0	99999 ± 99999	-2.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Indirect Bilirubin,Week 36,n=0,1,0,0,0	99999 ± 99999	-4.0 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Creatinine,Week 4,n=3,3,2,1,2	-7.07 ± 7.887	-0.63 ± 4.842	-1.30 ± 9.334	-0.90 ± 99999	3.95 ± 19.445
Creatinine,Week 8,n=2,1,2,0,2	-8.40 ± 0.566	-18.60 ± 99999	-5.25 ± 3.748	99999 ± 99999	-5.75 ± 5.728
Creatinine,Week 12,n=1,1,1,1,1	-6.20 ± 99999	-27.40 ± 99999	5.30 ± 99999	9.70 ± 99999	-19.50 ± 99999
Creatinine,Week 16,n=0,1,1,1,0	99999 ± 99999	-19.50 ± 99999	5.30 ± 99999	5.30 ± 99999	99999 ± 99999
Creatinine,Week 24,n=0,1,0,0,0	99999 ± 99999	-27.40 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Creatinine,Week 36,n=0,1,0,0,0	99999 ± 99999	-21.20 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Cumulative prednisone dose over time for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

Top of page

End point title

Part B: Cumulative prednisone dose over time for participants who received at least one dose of 100 mg open-label Sirukumab in Part B

End point description

Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Milligrams
arithmetic mean (standard deviation)
Week 2, n=0,0,0,1,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	561.000 ± 99999	550.000 ± 99999
Week 4,n=0,0,0,2,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	596.125 ± 586.7219	775.000 ± 99999
Week 8,n=0,0,0,2,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	956.125 ± 851.8869	99999 ± 99999
Week 12,n=0,0,0,2,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	1201.125 ± 1000.3793	1600.000 ± 99999
Week 14,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	843.750 ± 99999	99999 ± 99999
Week 16,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	1233.750 ± 99999	99999 ± 99999
Week 24,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	1853.750 ± 99999	99999 ± 99999
Week 28,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	1908.500 ± 99999	99999 ± 99999
Week 32,n=0,0,0,0,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	1600.000 ± 99999
Week 38,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	2153.750 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Cumulative prednisone dose over time for participants who never received 100 mg open label Sirukumab in Part B

Top of page

End point title

Part B: Cumulative prednisone dose over time for participants who never received 100 mg open label Sirukumab in Part B

End point description

Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

End point values	PartBSIR 100 mg SC q2w+6 month prednisone	PartBSIR 100 mg SC q2w+3 month prednisone	PartBSIR 50 mg SC q4w+6 month prednisone	PartBPlacebo SC q2w + 6 month prednisone	PartBPlacebo SC q2w + 12 month prednisone
Number of subjects analysed	6	4	3	3	2
Units: Milligrams
arithmetic mean (standard deviation)
Week 2, n=0,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 4,n=0,0,0,1,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	203.750 ± 99999	325.000 ± 99999
Week 8,n=0,0,0,1,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	357.500 ± 99999	596.250 ± 99999
Week 12,n=0,0,0,0,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	830.000 ± 99999
Week 14,n=0,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 16,n=0,0,0,0,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	1020.000 ± 99999
Week 24,n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	397.500 ± 99999	99999 ± 99999
Week 28,n= 0,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 32,n=0,0,0,0,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	1211.250 ± 99999
Week 38,n=0,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Number of disease flares over time

Top of page

End point title

Part B: Number of disease flares over time

End point description

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	8	5	4	5	4
Units: Disease flares
Week 2, n=1,1,0,1,2
Week 4, n=5,4,4,3,4
Week 8, n=4,2,3,2,3
Week 12, n=3,2,2,2,1
Week 14, n=0,0,0,1,0
Week 16, n=2,1,1,2,0
Week 24, n=2,1,0,0,0
Week 36, n=2,1,0,0,0
Week 38, n=1,0,0,0,0
Week 40, n=1,0,0,0,0

No statistical analyses for this end point

Secondary: Part B: Number of participants requiring at least one hospitalization for disease flare

Top of page

End point title

Part B: Number of participants requiring at least one hospitalization for disease flare

End point description

Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: “Severe Flare including Hospitalizations”. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.

End point type

Secondary

End point timeframe

Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	8	5	4	5	4
Units: Participants	9999999	9999999	9999999	9999999	9999999

No statistical analyses for this end point

Secondary: Part B: Number of hospitalizations for disease flare over time

Top of page

End point title

Part B: Number of hospitalizations for disease flare over time

End point description

End point type

Secondary

End point timeframe

Up to Week 104

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	8	5	4	5	4
Units: Number of hospitalizations	9999999	9999999	9999999	9999999	9999999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Scores on scale
number (not applicable)
Par 1, Week 12, Physical Functioning	10	99999	99999	99999	99999
Par 1, Week 12, Role Physical	12.5	99999	99999	99999	99999
Par 1, Week 12, Bodily Pain	-39	99999	99999	99999	99999
Par 1, Week 12, General Health	0	99999	99999	99999	99999
Par 1, Week 12, Vitality	-6.25	99999	99999	99999	99999
Par 1, Week 12, Social Functioning	0	99999	99999	99999	99999
Par 1, Week 12, Role Emotional	-8.33	99999	99999	99999	99999
Par 1, Week 12, Mental Health	10	99999	99999	99999	99999
Par 1, Week 12, Physical Component Summary	-8.76	99999	99999	99999	99999
Par 1, Week 12, Mental Component Summary	3.29	99999	99999	99999	99999
Par 1, Week 24, Physical Functioning	-4.99	99999	99999	99999	99999
Par 1, Week 24, Role Physical	-12.5	99999	99999	99999	99999
Par 1, Week 24, Bodily Pain	1	99999	99999	99999	99999
Par 1, Week 24, General Health	-5	99999	99999	99999	99999
Par 1, Week 24, Vitality	0	99999	99999	99999	99999
Par 1, Week 24, Social Functioning	0	99999	99999	99999	99999
Par 1, Week 24, Role Emotional	-16.67	99999	99999	99999	99999
Par 1, Week 24, Mental Health	5	99999	99999	99999	99999
Par 1, Week 24, Physical Component Summary	-2.09	99999	99999	99999	99999
Par 1, Week 24, Mental Component Summary	-0.76	99999	99999	99999	99999
Par 1, Day 339, Physical Functioning	9.99	99999	99999	99999	99999
Par 1, Day 339, Role Physical	37.5	99999	99999	99999	99999
Par 1, Day 339, Bodily Pain	23	99999	99999	99999	99999
Par 1, Day 339, General Health	5	99999	99999	99999	99999
Par 1, Day 339, Vitality	6.25	99999	99999	99999	99999
Par 1, Day 339, Social Functioning	0	99999	99999	99999	99999
Par 1, Day 339, Role Emotional	0	99999	99999	99999	99999
Par 1, Day 339, Mental Health	0	99999	99999	99999	99999
Par 1, Day 339, Physical Component Summary	9.98	99999	99999	99999	99999
Par 1, Day 339, Mental Component Summary	-2.78	99999	99999	99999	99999
Par 2, Week 12, Physical Functioning	4.99	99999	99999	99999	99999
Par 2, Week 12, Role Physical	50	99999	99999	99999	99999
Par 2, Week 12, Bodily Pain	49	99999	99999	99999	99999
Par 2, Week 12, General Health	10	99999	99999	99999	99999
Par 2, Week 12, Vitality	0	99999	99999	99999	99999
Par 2, Week 12, Social Functioning	12.5	99999	99999	99999	99999
Par 2, Week 12, Role Emotional	99999	99999	99999	99999	99999
Par 2, Week 12, Mental Health	-10	99999	99999	99999	99999
Par 2, Week 12, Physical Component Summary	15.7	99999	99999	99999	99999
Par 2, Week 12, Mental Component Summary	-5.84	99999	99999	99999	99999
Par 2, Week 24, Physical Functioning	24.99	99999	99999	99999	99999
Par 2, Week 24, Role Physical	50	99999	99999	99999	99999
Par 2, Week 24, Bodily Pain	33	99999	99999	99999	99999
Par 2, Week 24, General Health	5	99999	99999	99999	99999
Par 2, Week 24, Vitality	-6.25	99999	99999	99999	99999
Par 2, Week 24, Social Functioning	12.5	99999	99999	99999	99999
Par 2, Week 24, Role Emotional	0	99999	99999	99999	99999
Par 2, Week 24, Mental Health	-20	99999	99999	99999	99999
Par 2, Week 24, Physical Component Summary	17.37	99999	99999	99999	99999
Par 2, Week 24, Mental Component Summary	-10.18	99999	99999	99999	99999
Par 2, Day 344, Physical Functioning	-5.01	99999	99999	99999	99999
Par 2, Day 344, Role Physical	37.5	99999	99999	99999	99999
Par 2, Day 344, Bodily Pain	11	99999	99999	99999	99999
Par 2, Day 344, General Health	10	99999	99999	99999	99999
Par 2, Day 344, Vitality	-6.25	99999	99999	99999	99999
Par 2, Day 344, Social Functioning	12.5	99999	99999	99999	99999
Par 2, Day 344, Role Emotional	0	99999	99999	99999	99999
Par 2, Day 344, Mental Health	-15	99999	99999	99999	99999
Par 2, Day 344, Physical Component Summary	8.12	99999	99999	99999	99999
Par 2, Day 344, Mental Component Summary	-4.89	99999	99999	99999	99999
Par 3, Day 113, Physical Functioning	99999	99999	-10	99999	99999
Par 3, Day 113, Role Physical	99999	99999	0	99999	99999
Par 3, Day 113, Bodily Pain	99999	99999	0	99999	99999
Par 3, Day 113, General Health	99999	99999	-5	99999	99999
Par 3, Day 113, Vitality	99999	99999	-6.25	99999	99999
Par 3, Day 113, Social Functioning	99999	99999	99999	99999	99999
Par 3, Day 113, Role Emotional	99999	99999	0	99999	99999
Par 3, Day 113, Mental Health	99999	99999	-5	99999	99999
Par 3, Day 113, Physical Component Summary	99999	99999	-1.72	99999	99999
Par 3, Day 113, Mental Component Summary	99999	99999	-1.05	99999	99999
Par 4, Week 12, Physical Functioning	99999	15	99999	99999	99999
Par 4, Week 12, Role Physical	99999	6.25	99999	99999	99999
Par 4, Week 12, Bodily Pain	99999	33	99999	99999	99999
Par 4, Week 12, General Health	99999	-5	99999	99999	99999
Par 4, Week 12, Vitality	99999	0	99999	99999	99999
Par 4, Week 12, Social Functioning	99999	0	99999	99999	99999
Par 4, Week 12, Role Emotional	99999	0	99999	99999	99999
Par 4, Week 12, Mental Health	99999	5	99999	99999	99999
Par 4, Week 12, Physical Component Summary	99999	6.28	99999	99999	99999
Par 4, Week 12, Mental Component Summary	99999	-1.59	99999	99999	99999
Par 5, Week 12, Physical Functioning	99999	99999	99999	5	99999
Par 5, Week 12, Role Physical	99999	99999	99999	-18.75	99999
Par 5, Week 12, Bodily Pain	99999	99999	99999	-16	99999
Par 5, Week 12, General Health	99999	99999	99999	10	10
Par 5, Week 12, Vitality	99999	99999	99999	6.25	99999
Par 5, Week 12, Social Functioning	99999	99999	99999	-25	99999
Par 5, Week 12, Role Emotional	99999	99999	99999	-16.66	99999
Par 5, Week 12, Mental Health	99999	99999	99999	-5	99999
Par 5, Week 12, Physical Component Summary	99999	99999	99999	-0.34	99999
Par 5, Week 12, Mental Component Summary	99999	99999	99999	-5.35	99999
Par 5, Day 162, Physical Functioning	99999	99999	99999	10.01	99999
Par 5, Day 162, Role Physical	99999	99999	99999	-18.75	99999
Par 5, Day 162, Bodily Pain	99999	99999	99999	-16	99999
Par 5, Day 162, General Health	99999	99999	99999	-7	99999
Par 5, Day 162, Vitality	99999	99999	99999	-12.5	99999
Par 5, Day 162, Social Functioning	99999	99999	99999	-25	99999
Par 5, Day 162, Role Emotional	99999	99999	99999	-33.33	99999
Par 5, Day 162, Mental Health	99999	99999	99999	5	99999
Par 5, Day 162, Physical Component Summary	168	99999	99999	-1.62	99999
Par 5, Day 162, Mental Component Summary	99999	99999	99999	-8.24	99999
Par 6, Day 91, Physical Functioning	99999	99999	99999	-15	99999
Par 6, Day 91, Role Physical	99999	99999	99999	-25	99999
Par 6, Day 91, Bodily Pain	99999	99999	99999	22	99999
Par 6, Day 91, General Health	99999	99999	99999	0	99999
Par 6, Day 91, Vitality	99999	99999	99999	-6.25	99999
Par 6, Day 91, Social Functioning	99999	99999	99999	0	99999
Par 6, Day 91, Role Emotional	99999	99999	99999	0	99999
Par 6, Day 91, Mental Health	99999	99999	99999	20	99999
Par 6, Day 91, Physical Component Summary	99999	99999	99999	-5.17	99999
Par 6, Day 91, Mental Component Summary	99999	99999	99999	5.95	99999
Par 7, Day 85, Physical Functioning	99999	99999	99999	99999	-10.01
Par 7, Day 85, Role Physical	99999	99999	99999	99999	-6.25
Par 7, Day 85, Bodily Pain	99999	99999	99999	99999	-22
Par 7, Day 85, General Health	99999	99999	99999	99999	10
Par 7, Day 85, Vitality	99999	99999	99999	99999	-12.5
Par 7, Day 85, Social Functioning	99999	99999	99999	99999	99999
Par 7, Day 85, Role Emotional	99999	99999	99999	99999	99999
Par 7, Day 85, Mental Health	99999	99999	99999	99999	5
Par 7, Day 85, Physical Component Summary	99999	99999	99999	99999	-4.79
Par 7, Day 85, Mental Component Summary	99999	99999	99999	99999	1.82
Par 8, Day 87, Physical Functioning	99999	99999	99999	99999	0
Par 8, Day 87, Role Physical	99999	99999	99999	99999	6.25
Par 8, Day 87, Bodily Pain	99999	99999	99999	99999	21
Par 8, Day 87, General Health	99999	99999	99999	99999	0
Par 8, Day 87, Vitality	99999	99999	99999	99999	0
Par 8, Day 87, Social Functioning	99999	99999	99999	99999	12.5
Par 8, Day 87, Role Emotional	99999	99999	99999	99999	16.66
Par 8, Day 87, Mental Health	99999	99999	99999	99999	5
Par 8, Day 87, Physical Component Summary	99999	99999	99999	99999	1.52
Par 8, Day 87, Mental Component Summary	99999	99999	99999	99999	4.54

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in 36-item SF-36 v2 acute score over time for participants who never received 100 mg OL Sirukumab in Part B

End point description

SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12

End point values	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone
Number of subjects analysed	2	2	6	4	3
Units: Scores on scale
number (not applicable)
Par 1, Day 30, Physical Functioning	99999	99999	-5	99999	99999
Par 1, Day 30, Role Physical	99999	99999	0	99999	99999
Par 1, Day 30, Bodily Pain	99999	99999	-16	99999	99999
Par 1, Day 30, General health	99999	99999	10	99999	99999
Par 1, Day 30, Vitality	99999	99999	0	99999	99999
Par 1, Day 30, Social Functioning	99999	99999	0	99999	99999
Par 1, Day 30, Role emotional	99999	99999	0	99999	99999
Par 1, Day 30, Mental health	99999	99999	5	99999	99999
Par 1, Day 30, Physical Component Summary	99999	99999	-2.26	99999	99999
Par 1, Day 30, Mental Component Summary	99999	99999	2.26	99999	99999
Par 2, Day 29, Physical Functioning	99999	99999	0	99999	99999
Par 2, Day 29, Role Physical	99999	99999	0	99999	99999
Par 2, Day 29, Bodily Pain	99999	99999	0	99999	99999
Par 2, Day 29, General health	99999	99999	8	99999	99999
Par 2, Day 29, Vitality	99999	99999	6.25	99999	99999
Par 2, Day 29, Social Functioning	99999	99999	0	99999	99999
Par 2, Day 29, Role emotional	99999	99999	0	99999	99999
Par 2, Day 29, Mental health	99999	99999	10	99999	99999
Par 2, Day 29, Physical Component Summary	99999	99999	-0.12	99999	99999
Par 2, Day 29, Mental Component Summary	99999	99999	3.18	99999	99999
Par 3, Day 23, Physical Functioning	99999	99999	25	99999	99999
Par 3, Day 23, Role Physical	99999	99999	6.25	99999	99999
Par 3, Day 23, Bodily Pain	99999	99999	49	99999	99999
Par 3, Day 23, General health	99999	99999	10	99999	99999
Par 3, Day 23, Vitality	99999	99999	0	99999	99999
Par 3, Day 23, Social Functioning	99999	99999	0	99999	99999
Par 3, Day 23, Role emotional	99999	99999	0	99999	99999
Par 3, Day 23, Mental health	99999	99999	-5	99999	99999
Par 3, Day 23, Physical Component Summary	99999	99999	12.88	99999	99999
Par 3, Day 23, Mental Component Summary	99999	99999	-5.75	99999	99999
Par 4, Week 12, Physical Functioning	99999	99999	15	99999	99999
Par 4, Week 12, Role Physical	99999	99999	18.75	99999	99999
Par 4, Week 12, Bodily Pain	99999	99999	0	99999	99999
Par 4, Week 12, General health	99999	99999	0	99999	99999
Par 4, Week 12, Vitality	99999	99999	6.25	99999	99999
Par 4, Week 12, Social Functioning	99999	99999	0	99999	99999
Par 4, Week 12, Role emotional	99999	99999	0	99999	99999
Par 4, Week 12, Mental health	99999	99999	0	99999	99999
Par 4, Week 12, Physical Component Summary	99999	99999	4.88	99999	99999
Par 4, Week 12, Mental Component Summary	99999	99999	-1.45	99999	99999
Par 4, Day 113, Physical Functioning	99999	99999	15	99999	99999
Par 4, Day 113, Role Physical	99999	99999	0	99999	99999
Par 4, Day 113, Bodily Pain	99999	99999	0	99999	99999
Par 4, Day 113, General health	99999	99999	10	99999	99999
Par 4, Day 113, Vitality	99999	99999	0	99999	99999
Par 4, Day 113, Social Functioning	99999	99999	-12.5	99999	99999
Par 4, Day 113, Role emotional	99999	99999	0	99999	99999
Par 4, Day 113, Mental health	99999	99999	25	99999	99999
Par 4, Day 113, Physical Component Summary	99999	99999	0.77	99999	99999
Par 4, Day 113, Mental Component Summary	99999	99999	3.61	99999	99999
Par 5, Week 8, Physical Functioning	99999	99999	-5	99999	99999
Par 5, Week 8, Role Physical	99999	99999	0	99999	99999
Par 5, Week 8, Bodily Pain	99999	99999	10	99999	99999
Par 5, Week 8, General health	99999	99999	-10	99999	99999
Par 5, Week 8, Vitality	99999	99999	-6.25	99999	99999
Par 5, Week 8, Social Functioning	99999	99999	-12.5	99999	99999
Par 5, Week 8, Role emotional	99999	99999	16.67	99999	99999
Par 5, Week 8, Mental health	99999	99999	0	99999	99999
Par 5, Week 8, Physical Component Summary	99999	99999	-2.1	99999	99999
Par 5, Week 8, Mental Component Summary	99999	99999	1.1	99999	99999
Par 5, Day 85, Physical Functioning	99999	99999	5	99999	99999
Par 5, Day 85, Role Physical	99999	99999	-6.25	99999	99999
Par 5, Day 85, Bodily Pain	99999	99999	10	99999	99999
Par 5, Day 85, General health	99999	99999	-22	99999	99999
Par 5, Day 85, Vitality	99999	99999	-6.25	99999	99999
Par 5, Day 85, Social Functioning	99999	99999	-12.5	99999	99999
Par 5, Day 85, Role emotional	99999	99999	8.33	99999	99999
Par 5, Day 85, Mental health	99999	99999	10	99999	99999
Par 5, Day 85, Physical Component Summary	99999	99999	-3.17	99999	99999
Par 5, Day 85, Mental Component Summary	99999	99999	1.62	99999	99999
Par 6, Day 65, Physical Functioning	99999	99999	0	99999	99999
Par 6, Day 65, Role Physical	99999	99999	6.25	99999	99999
Par 6, Day 65, Bodily Pain	99999	99999	0	99999	99999
Par 6, Day 65, General health	99999	99999	0	99999	99999
Par 6, Day 65, Vitality	99999	99999	-6.25	99999	99999
Par 6, Day 65, Social Functioning	99999	99999	12.5	99999	99999
Par 6, Day 65, Role emotional	99999	99999	8.33	99999	99999
Par 6, Day 65, Mental health	99999	99999	0	99999	99999
Par 6, Day 65, Physical Component Summary	99999	99999	-0.01	99999	99999
Par 6, Day 65, Mental Component Summary	99999	99999	1.88	99999	99999
Par 7, Week 12, Physical Functioning	99999	99999	99999	0	99999
Par 7, Week 12, Role Physical	99999	99999	99999	6.25	99999
Par 7, Week 12, Bodily Pain	99999	99999	99999	16	99999
Par 7, Week 12, General health	99999	99999	99999	0	99999
Par 7, Week 12, Vitality	99999	99999	99999	-6.25	99999
Par 7, Week 12, Social Functioning	99999	99999	99999	0	99999
Par 7, Week 12, Role emotional	99999	99999	99999	0	99999
Par 7, Week 12, Mental health	99999	99999	99999	-5	99999
Par 7, Week 12, Physical Component Summary	99999	99999	99999	-3.33	99999
Par 7, Week 12, Mental Component Summary	99999	99999	99999	-2.88	99999
Par 7, Day 373, Physical Functioning	99999	99999	99999	15	99999
Par 7, Day 373, Role Physical	99999	99999	99999	6.25	99999
Par 7, Day 373, Bodily Pain	99999	99999	99999	16	99999
Par 7, Day 373, General health	99999	99999	99999	8	99999
Par 7, Day 373, Vitality	99999	99999	99999	0	99999
Par 7, Day 373, Social Functioning	99999	99999	99999	0	99999
Par 7, Day 373, Role emotional	99999	99999	99999	0	99999
Par 7, Day 373, Mental health	99999	99999	99999	-15	99999
Par 7, Day 373, Physical Component Summary	99999	99999	99999	7.95	99999
Par 7, Day 373, Mental Component Summary	99999	99999	99999	-6.1	99999
Par 8, Day 64, Physical Functioning	99999	99999	99999	5	99999
Par 8, Day 64, Role Physical	99999	99999	99999	-6.25	99999
Par 8, Day 64, Bodily Pain	99999	99999	99999	-22	99999
Par 8, Day 64, General health	99999	99999	99999	0	99999
Par 8, Day 64, Vitality	99999	99999	99999	-12.5	99999
Par 8, Day 64, Social Functioning	99999	99999	99999	0	99999
Par 8, Day 64, Role emotional	99999	99999	99999	25	99999
Par 8, Day 64, Mental health	99999	99999	99999	-15	99999
Par 8, Day 64, Physical Component Summary	99999	99999	99999	-3.24	99999
Par 8, Day 64, Mental Component Summary	99999	99999	99999	0.02	99999
Par 9, Day 29, Physical Functioning	99999	99999	99999	10	99999
Par 9, Day 29, Role Physical	99999	99999	99999	6.25	99999
Par 9, Day 29, Bodily Pain	99999	99999	99999	0	99999
Par 9, Day 29, General health	99999	99999	99999	-3	99999
Par 9, Day 29, Vitality	99999	99999	99999	0	99999
Par 9, Day 29, Social Functioning	99999	99999	99999	0	99999
Par 9, Day 29, Role emotional	99999	99999	99999	0	99999
Par 9, Day 29, Mental health	99999	99999	99999	-10	99999
Par 9, Day 29, Physical Component Summary	99999	99999	99999	3.22	99999
Par 9, Day 29, Mental Component Summary	99999	99999	99999	-3.68	99999
Par 10, Day 57, Physical Functioning	99999	99999	99999	0	99999
Par 10, Day 57, Role Physical	99999	99999	99999	12.5	99999
Par 10, Day 57, Bodily Pain	99999	99999	99999	0	99999
Par 10, Day 57, General health	99999	99999	99999	-5	99999
Par 10, Day 57, Vitality	99999	99999	99999	0	99999
Par 10, Day 57, Social Functioning	99999	99999	99999	12.5	99999
Par 10, Day 57, Role emotional	99999	99999	99999	0	99999
Par 10, Day 57, Mental health	99999	99999	99999	0	99999
Par 10, Day 57, Physical Component Summary	99999	99999	99999	0.95	99999
Par 10, Day 57, Mental Component Summary	99999	99999	99999	0.83	99999
Par 11, Week 12, Physical Functioning	99999	99999	99999	99999	-29.99
Par 11, Week 12, Role Physical	99999	99999	99999	99999	-18.75
Par 11, Week 12, Bodily Pain	99999	99999	99999	99999	0
Par 11, Week 12, General health	99999	99999	99999	99999	-13
Par 11, Week 12, Vitality	99999	99999	99999	99999	-6.25
Par 11, Week 12, Social Functioning	99999	99999	99999	99999	-25
Par 11, Week 12, Role emotional	99999	99999	99999	99999	0
Par 11, Week 12, Mental health	99999	99999	99999	99999	5
Par 11, Week 12, Physical Component Summary	99999	99999	99999	99999	-9.37
Par 11, Week 12, Mental Component Summary	99999	99999	99999	99999	1.44
Par 11, Day 163, Physical Functioning	99999	99999	99999	99999	-15.01
Par 11, Day 163, Role Physical	99999	99999	99999	99999	6.25
Par 11, Day 163, Bodily Pain	99999	99999	99999	99999	0
Par 11, Day 163, General health	99999	99999	99999	99999	-8
Par 11, Day 163, Vitality	99999	99999	99999	99999	0
Par 11, Day 163, Social Functioning	99999	99999	99999	99999	-37.5
Par 11, Day 163, Role emotional	99999	99999	99999	99999	9
Par 11, Day 163, Mental health	99999	99999	99999	99999	10
Par 11, Day 163, Physical Component Summary	99999	99999	99999	99999	-3.64
Par 11, Day 163, Mental Component Summary	99999	99999	99999	99999	-0.4
Par 12, Day 85, Physical Functioning	99999	99999	99999	99999	-5
Par 12, Day 85, Role Physical	99999	99999	99999	99999	-6.25
Par 12, Day 85, Bodily Pain	99999	99999	99999	99999	-11
Par 12, Day 85, General health	99999	99999	99999	99999	-5
Par 12, Day 85, Vitality	99999	99999	99999	99999	6.25
Par 12, Day 85, Social Functioning	99999	99999	99999	99999	0
Par 12, Day 85, Role emotional	99999	99999	99999	99999	-16.67
Par 12, Day 85, Mental health	99999	99999	99999	99999	5
Par 12, Day 85, Physical Component Summary	99999	99999	99999	99999	-2.76
Par 12, Day 85, Mental Component Summary	99999	99999	99999	99999	0.13
Par 13, Day 59, Physical Functioning	99999	99999	99999	99999	5
Par 13, Day 59, Role Physical	99999	99999	99999	99999	-12.5
Par 13, Day 59, Bodily Pain	99999	99999	99999	99999	0
Par 13, Day 59, General health	99999	99999	99999	99999	0
Par 13, Day 59, Vitality	99999	99999	99999	99999	0
Par 13, Day 59, Social Functioning	99999	99999	99999	99999	-12.5
Par 13, Day 59, Role emotional	99999	99999	99999	99999	0
Par 13, Day 59, Mental health	99999	99999	99999	99999	-25
Par 13, Day 59, Physical Component Summary	99999	99999	99999	99999	2.16
Par 13, Day 59, Mental Component Summary	99999	99999	99999	99999	-7.59
Par 14, Day 57, Physical Functioning	-5.01	99999	99999	99999	99999
Par 14, Day 57, Role Physical	-18.75	99999	99999	99999	99999
Par 14, Day 57, Bodily Pain	-32	99999	99999	99999	99999
Par 14, Day 57, General health	10	99999	99999	99999	99999
Par 14, Day 57, Vitality	12.5	99999	99999	99999	99999
Par 14, Day 57, Social Functioning	-37.5	99999	99999	99999	99999
Par 14, Day 57, Role emotional	0	99999	99999	99999	99999
Par 14, Day 57, Mental health	15	99999	99999	99999	99999
Par 14, Day 57, Physical Component Summary	-7.54	99999	99999	99999	99999
Par 14, Day 57, Mental Component Summary	3.62	99999	99999	99999	99999
Par 15, Day 169, Physical Functioning	4.99	99999	99999	99999	99999
Par 15, Day 169, Role Physical	50	99999	99999	99999	99999
Par 15, Day 169, Bodily Pain	33	99999	99999	99999	99999
Par 15, Day 169, General health	5	99999	99999	99999	99999
Par 15, Day 169, Vitality	6.25	99999	99999	99999	99999
Par 15, Day 169, Social Functioning	25	99999	99999	99999	99999
Par 15, Day 169, Role emotional	50	99999	99999	99999	99999
Par 15, Day 169, Mental health	0	99999	99999	99999	99999
Par 15, Day 169, Physical Component Summary	7.93	99999	99999	99999	99999
Par 15, Day 169, Mental Component Summary	8.48	99999	99999	99999	99999
Par 16, Week 12, Physical Functioning	99999	5	99999	99999	99999
Par 16, Week 12, Role Physical	99999	6.25	99999	99999	99999
Par 16, Week 12, Bodily Pain	99999	28	99999	99999	99999
Par 16, Week 12, General health	99999	0	99999	99999	99999
Par 16, Week 12, Vitality	99999	-6.25	99999	99999	99999
Par 16, Week 12, Social Functioning	99999	0	99999	99999	99999
Par 16, Week 12, Role emotional	99999	0	99999	99999	99999
Par 16, Week 12, Mental health	99999	0	99999	99999	99999
Par 16, Week 12, Physical Component Summary	99999	5.1	99999	99999	99999
Par 16, Week 12, Mental Component Summary	99999	-2.52	99999	99999	99999
Par 16, Day 112, Physical Functioning	99999	0	99999	99999	99999
Par 16, Day 112, Role Physical	99999	12.5	99999	99999	99999
Par 16, Day 112, Bodily Pain	99999	28	99999	99999	99999
Par 16, Day 112, General health	99999	-20	99999	99999	99999
Par 16, Day 112, Vitality	99999	-6.25	99999	99999	99999
Par 16, Day 112, Social Functioning	99999	0	99999	99999	99999
Par 16, Day 112, Role emotional	99999	0	99999	99999	99999
Par 16, Day 112, Mental health	99999	0	99999	99999	99999
Par 16, Day 112, Physical Component Summary	99999	2.71	99999	99999	99999
Par 16, Day 112, Mental Component Summary	99999	-2.21	99999	99999	99999
Par 17, Day 85, Physical Functioning	99999	-10	99999	99999	99999
Par 17, Day 85, Role Physical	99999	-25	99999	99999	99999
Par 17, Day 85, Bodily Pain	99999	-10	99999	99999	99999
Par 17, Day 85, General health	99999	0	99999	99999	99999
Par 17, Day 85, Vitality	99999	6.25	99999	99999	99999
Par 17, Day 85, Social Functioning	99999	-12.5	99999	99999	99999
Par 17, Day 85, Role emotional	99999	0	99999	99999	99999
Par 17, Day 85, Mental health	99999	5	99999	99999	99999
Par 17, Day 85, Physical Component Summary	99999	-6.51	99999	99999	99999
Par 17, Day 85, Mental Component Summary	99999	3.01	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no; 2: slight 3: moderate and 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant’s health state: e.g. state 11111 indicates no problem on any of the 5 dimensions, while state 12345 indicates no problems with Mobility, slight problems with Self-Care, moderate problems with doing Usual Activities, severe Pain or Discomfort and extreme Anxiety or Depression. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Scores on scale
number (not applicable)
Par 1, Week 12	-0.127	99999	99999	99999	99999
Par 1, Week 24	-0.098	99999	99999	99999	99999
Par 1, Day 339	-0.070	99999	99999	99999	99999
Par 2, Week 12	0.204	99999	99999	99999	99999
Par 2, Week 24	0.041	99999	99999	99999	99999
Par 2, Day 344	0.110	99999	99999	99999	99999
Par 3, Day 113	99999	99999	0.000	99999	99999
Par 4, Week 12	99999	0.097	99999	99999	99999
Par 5, Week 12	99999	99999	99999	0.028	99999
Par 5, Day 162	99999	99999	99999	0.028	99999
Par 6, Day 91	99999	99999	99999	0.000	99999
Par 7, Day 85	99999	99999	99999	99999	0.000
Par 8, Day 87	99999	99999	99999	99999	0.012

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who never received 100mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in EQ-5D-5L Index score over time for participants who never received 100mg OL Sirukumab in Part B

End point description

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant’s health state: e.g. state 11111 indicates no problem on any of the 5 dimensions, while state 12345 indicates no problems with Mobility, slight problems with Self-Care, moderate problems with doing Usual Activities, severe Pain or Discomfort and extreme Anxiety or Depression. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: Scores on scale
number (not applicable)
Par 1, Day 30	99999	-0.248	99999	99999	99999
Par 2, Day 29	99999	0.000	99999	99999	99999
Par 3, Day 29	99999	0.233	99999	99999	99999
Par 4, Week 12	99999	0.000	99999	99999	99999
Par 4, Day 113	99999	0.000	99999	99999	99999
Par 5, Day 85	99999	-0.015	99999	99999	99999
Par 6, Day 65	99999	0.163	99999	99999	99999
Par 7, Week 12	99999	99999	0.163	99999	99999
Par 7, Day 373	99999	99999	0.163	99999	99999
Par 8, Day 64	99999	99999	-0.016	99999	99999
Par 9, Day 29	99999	99999	0.212	99999	99999
Par 10, Day 57	99999	99999	0.000	99999	99999
Par 11, Week 12	99999	99999	99999	-0.069	99999
Par 11, Day 163	99999	99999	99999	0.042	99999
Par 12, Day 85	99999	99999	99999	-0.059	99999
Par 13, Day 59	99999	99999	99999	0.000	99999
Par 14, Day 57	99999	99999	99999	99999	0.000
Par 16, Day 169	99999	99999	99999	99999	0.232
Par 17,Week 12	0.163	99999	99999	99999	99999
Par 17, Day 112	0.163	99999	99999	99999	99999
Par 18, Day 85	-0.042	99999	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Scores on scale
number (not applicable)
Par 1, Week 12, I Feel Fatigued	-3	99999	99999	99999	99999
Par 1, Week 24, I Feel Fatigued	-4	99999	99999	99999	99999
Par 1, Day 339, I Feel Fatigued	3	99999	99999	99999	99999
Par 2, Week 12, I Feel Fatigued	8	99999	99999	99999	99999
Par 2, Week 24, I Feel Fatigued	2	99999	99999	99999	99999
Par 2, Day 344, I Feel Fatigued	6	99999	99999	99999	99999
Par 3, Day 113, I Feel Fatigued	99999	99999	2	99999	99999
Par 4, Week 12, I Feel Fatigued	99999	2	99999	99999	99999
Par 5, Week 12, I Feel Fatigued	99999	99999	99999	-5	99999
Par 5, Day 162, I Feel Fatigued	99999	99999	99999	-4	99999
Par 6, Day 91, I Feel Fatigued	99999	99999	99999	-12	99999
Par 7, Day 85, I Feel Fatigued	99999	99999	99999	99999	-7
Par 8, Day 87, I Feel Fatigued	99999	99999	99999	99999	-10

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who never received 100mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in FACIT-Fatigue scores over time for participants who never received 100mg OL Sirukumab in Part B

End point description

The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: Scores on scale
number (not applicable)
Par 1, Day 30, I Feel Fatigued	99999	-3	99999	99999	99999
Par 2, Day 29, I Feel Fatigued	99999	-1	99999	99999	99999
Par 3, Day 23, I Feel Fatigued	99999	0	99999	99999	99999
Par 4, Week 12, I Feel Fatigued	99999	2	99999	99999	99999
Par 4, Day 113, I Feel Fatigued	99999	-16	99999	99999	99999
Par 5, Week 8, I Feel Fatigued	99999	-1	99999	99999	99999
Par 5, Day 85, I Feel Fatigued	99999	-3	99999	99999	99999
Par 6, Day 65, I Feel Fatigued	99999	-1	99999	99999	99999
Par 7, Week 12, I Feel Fatigued	99999	99999	0	99999	99999
Par 7, Day 373, I Feel Fatigued	99999	99999	5	99999	99999
Par 8, Day 64, I Feel Fatigued	99999	99999	-3	99999	99999
Par 9, Day 29, I Feel Fatigued	99999	99999	0	99999	99999
Par 10, Day 57, I Feel Fatigued	99999	99999	13	99999	99999
Par 11, Week 12, I Feel Fatigued	99999	99999	99999	5	99999
Par 11, Day 163, I Feel Fatigued	99999	99999	99999	6	99999
Par 12, Day 85, I Feel Fatigued	99999	99999	99999	-1	99999
Par 13, Day 59, I Feel Fatigued	99999	99999	99999	7	99999
Par 14, Day 57, I Feel Fatigued	99999	99999	99999	99999	-11
Par 16, Day 169, I Feel Fatigued	99999	99999	99999	99999	0
Par 17, Week 12, I Feel Fatigued	6	99999	99999	99999	99999
Par 17, Day112, I Feel Fatigued	6	99999	99999	99999	99999
Par 18, Day 85, I Feel Fatigued	-1	99999	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in Pain NRS scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in Pain NRS scores over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, “no pain” to 10, “the worst pain imaginable”. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Scores on scale
number (not applicable)
Par 1, Week 2	4	99999	99999	99999	99999
Par 1, Week 4	-1	99999	99999	99999	99999
Par 1, Week 8	-1	99999	99999	99999	99999
Par 1, Week 12	4	99999	99999	99999	99999
Par 1, Week 24	0	99999	99999	99999	99999
Par 1, Day 339	-2	99999	99999	99999	99999
Par 2, Week 4	0	99999	99999	99999	99999
Par 2, Week 8	0	99999	99999	99999	99999
Par 2, Week 12	1	99999	0	99999	99999
Par 2, Week 24	0	99999	99999	99999	99999
Par 2, Week 38	1	99999	99999	99999	99999
Par 2, Week 40	1	99999	99999	99999	99999
Par 2, Day 344	0	99999	99999	99999	99999
Par 3, Day 113	99999	99999	-2	99999	99999
Par 4, Week 4	99999	-2	99999	99999	99999
Par 4, Week 8	99999	0	99999	99999	99999
Par 4, Week 12	99999	-3	99999	99999	99999
Par 5, Week 4	99999	99999	99999	0	99999
Par 5, Week 8	99999	99999	99999	1	99999
Par 5, Week 12	99999	99999	99999	0	99999
Par 5, Week 14	99999	99999	99999	1	99999
Par 5, Week 16	99999	99999	99999	0	99999
Par 5, Day 162	99999	99999	99999	1	99999
Par 6, Week 2	99999	99999	99999	2	99999
Par 6, Week 4	99999	99999	99999	-2	99999
Par 6, Week 8	99999	99999	99999	-2	99999
Par 6, Day 91	99999	99999	99999	-1	99999
Par 7, Week 2	99999	99999	99999	99999	-1
Par 7, Week 4	99999	99999	99999	99999	0
Par 7, Week 8	99999	99999	99999	99999	1
Par 7, Day 85	99999	99999	99999	99999	0
Par 8, Week 2	99999	99999	99999	99999	2
Par 8, Week 4	99999	99999	99999	99999	0
Par 8, Day 87	99999	99999	99999	99999	0

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in Pain NRS scores over time for participants who never received at least one dose of 100mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in Pain NRS scores over time for participants who never received at least one dose of 100mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: Scores on scale
number (not applicable)
Par 1, Day 30	99999	0	99999	99999	99999
Par 2, Day 29	99999	0	99999	99999	99999
Par 3, Day 23	99999	-1	99999	99999	99999
Par 4, Week 4	99999	0	99999	99999	99999
Par 4, Week 8	99999	0	99999	99999	99999
Par 4, Week 12	99999	0	99999	99999	99999
Par 4, Day 113	99999	0	99999	99999	99999
Par 5, Week 4	99999	0	99999	99999	99999
Par 5, Week 8	99999	0	99999	99999	99999
Par 5, Day 85	99999	2	99999	99999	99999
Par 6, Week 4	99999	0	99999	99999	99999
Par 6, Day 65	99999	0	99999	99999	99999
Par 7, Week 4	99999	99999	1	99999	99999
Par 7, Week 8	99999	99999	0	99999	99999
Par 7, Week 12	99999	99999	0	99999	99999
Par 7, Day 373	99999	99999	0	99999	99999
Par 8, Week 4	99999	99999	0	99999	99999
Par 8, Day 64	99999	99999	-1	99999	99999
Par 9, Day 29	99999	99999	0	99999	99999
Par 10, Week 4	99999	99999	0	99999	99999
Par 10, Day 57	99999	99999	-1	99999	99999
Par 11, Week 4	99999	99999	99999	0	99999
Par 11, Week 8	99999	99999	99999	0	99999
Par 11, Week 12	99999	99999	99999	1	99999
Par 11, Day 163	99999	99999	99999	1	99999
Par 12, Week 4	99999	99999	99999	0	99999
Par 12, Week 8	99999	99999	99999	-1	99999
Par 12, Day 85	99999	99999	99999	0	99999
Par 13, Week 4	99999	99999	99999	0	99999
Par 13, Day 59	99999	99999	99999	0	99999
Par 14, Week 4	99999	99999	99999	99999	0
Par 14, Day 57	99999	99999	99999	99999	-1
Par 16, Day 169	99999	99999	99999	99999	-3
Par 17, Week 4	-2	99999	99999	99999	99999
Par 17, Week 12	-2	99999	99999	99999	99999
Par 17, Day 112	-2	99999	99999	99999	99999
Par 18, Week 8	1	99999	99999	99999	99999
Par 18, Day 85	0	99999	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: HAQDI Score over Time for participants who received at least one Dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: HAQDI Score over Time for participants who received at least one Dose of 100 mg OL Sirukumab in Part B

End point description

The HAQ-DI indicates the extent of the participant's functional ability during the past week, and was assessed for the subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). The HAQ-DI included 20 questions in 8 categories of functioning – dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 to 3, representing “no difficulty” (0), “some difficulty” (1), “much difficulty” (2), and “unable to do” (3) where higher scores indicating worse disability. The functional areas assesed were: activities, arising, dressing and gooming, eating, grip, hygiene, reach and walking.The score for each of the 8 category scores is taken as the maximum score given to the related questions. If no questions within a given functional area were answered, no score was provided for that category.

End point type

Secondary

End point timeframe

Day 87, 339, 344, Week 12, 24

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	0 ^[23]	0 ^[24]	1 ^[25]
Units: Scores on scale
number (not applicable)
Par 1, Week 12, Able to Do Chores	1	99999			99999
Par 1, Week 12, Get In and Out of a car	0	99999			99999
Par 1, Week 12, Run Errands and Shop	0	99999			99999
Par 1, Week 12, Get In and Out of Bed	0	99999			99999
Par 1, Week 12, Stand Up From a Straight	1	99999			99999
Par 1, Week 12, Dress yourself	1	99999			99999
Par 1, Week 12, Shampoo your hair	0	99999			99999
Par 1, Week 12, Cut your meat	0	99999			99999
Par 1, Week 12, Lift a Full Cup/Glass to mouth	0	99999			99999
Par 1, Week 12, Open a New Milk Carton	1	99999			99999
Par 1, Week 12, Open car doors	0	99999			99999
Par 1, Week 12, Open Jars Previously Opened	1	99999			99999
Par 1, Week 12, Turn Faucets On And Off	1	99999			99999
Par 1, Week 12, Get On and Off The Toilet	0	99999			99999
Par 1, Week 12, Take a Tub Bath	3	99999			99999
Par 1, Week 12, Wash and Dry Your Body	0	99999			99999
Par 1, Week 12, Bend Down Pick Up Clothing-Floor	1	99999			99999
Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head	1	99999			99999
Par 1, Week 12, Climb Up Five Steps	0	99999			99999
Par 1, Week 12, Walk Outdoors on Flat Ground	0	99999			99999
Par 1, Week 24, Able to Do Chores	0	99999			99999
Par 1, Week 24, Get In and Out of a car	0	99999			99999
Par 1, Week 24, Run Errands and Shop	0	99999			99999
Par 1, Week 24, Get In and Out of Bed	0	99999			99999
Par 1, Week 24, Stand Up From a Straight	0	99999			99999
Par 1, Week 24, Dress yourself	0	99999			99999
Par 1, Week 24, Shampoo your hair	0	99999			99999
Par 1, Week 24, Cut your meat	0	99999			99999
Par 1, Week 24, Lift a Full Cup/Glass to mouth	0	99999			99999
Par 1, Week 24, Open a New Milk Carton	0	99999			99999
Par 1, Week 24, Open car doors	0	99999			99999
Par 1, Week 24, Open Jars Previously Opened	1	99999			99999
Par 1, Week 24, Turn Faucets On And Off	1	99999			99999
Par 1, Week 24, Get On and Off The Toilet	0	99999			99999
Par 1, Week 24, Take a Tub Bath	3	99999			99999
Par 1, Week 24, Wash and Dry Your Body	0	99999			99999
Par 1, Week 24, Bend Down Pick Up Clothing-Floor	0	99999			99999
Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head	0	99999			99999
Par 1, Week 24, Climb Up Five Steps	0	99999			99999
Par 1, Week 24, Walk Outdoors on Flat Ground	0	99999			99999
Par 1, Day 339, Able to Do Chores	0	99999			99999
Par 1, Day 339, Get In and Out of a car	0	99999			99999
Par 1, Day 339, Run Errands and Shop	0	99999			99999
Par 1, Day 339, Get In and Out of Bed	0	99999			99999
Par 1, Day 339, Stand Up From a Straight	0	99999			99999
Par 1, Day 339, Dress yourself	0	99999			99999
Par 1, Day 339, Shampoo your hair	0	99999			99999
Par 1, Day 339, Cut your meat	0	99999			99999
Par 1, Day 339, Lift a Full Cup/Glass to mouth	0	99999			99999
Par 1, Day 339, Open a New Milk Carton	1	99999			99999
Par 1, Day 339, Open car doors	0	99999			99999
Par 1, Day 339, Open Jars Previously Opened	0	99999			99999
Par 1, Day 339, Turn Faucets On And Off	0	99999			99999
Par 1, Day 339, Get On and Off The Toilet	0	99999			99999
Par 1, Day 339, Take a Tub Bath	3	99999			99999
Par 1, Day 339, Wash and Dry Your Body	0	99999			99999
Par 1, Day 339, Bend Down Pick Up Clothing-Floor	0	99999			99999
Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head	0	99999			99999
Par 1, Day 339, Climb Up Five Steps	0	99999			99999
Par 1, Day 339, Walk Outdoors on Flat Ground	0	99999			99999
Par 2, Week 12, Able to Do Chores	1	99999			99999
Par 2, Week 12, Get In and Out of a car	0	99999			99999
Par 2, Week 12, Run Errands and Shop	0	99999			99999
Par 2, Week 12, Get In and Out of Bed	0	99999			99999
Par 2, Week 12, Stand Up From a Straight	0	99999			99999
Par 2, Week 12, Dress yourself	0	99999			99999
Par 2, Week 12, Shampoo your hair	0	99999			99999
Par 2, Week 12, Cut your meat	0	99999			99999
Par 2, Week 12, Lift a Full Cup/Glass to mouth	0	99999			99999
Par 2, Week 12, Open a New Milk Carton	1	99999			99999
Par 2, Week 12, Open car doors	0	99999			99999
Par 2, Week 12, Open Jars Previously Opened	0	99999			99999
Par 2, Week 12, Turn Faucets On And Off	0	99999			99999
Par 2, Week 12, Get On and Off The Toilet	0	99999			99999
Par 2, Week 12, Take a Tub Bath	3	99999			99999
Par 2, Week 12, Wash and Dry Your Body	0	99999			99999
Par 2, Week 12, Bend Down Pick Up Clothing-Floor	1	99999			99999
Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head	2	99999			99999
Par 2, Week 12, Climb Up Five Steps	0	99999			99999
Par 2, Week 12, Walk Outdoors on Flat Ground	0	99999			99999
Par 2, Week 24, Able to Do Chores	0	99999			99999
Par 2, Week 24, Get In and Out of a car	0	99999			99999
Par 2, Week 24, Run Errands and Shop	0	99999			99999
Par 2, Week 24, Get In and Out of Bed	0	99999			99999
Par 2, Week 24, Stand Up From a Straight	0	99999			99999
Par 2, Week 24, Dress yourself	0	99999			99999
Par 2, Week 24, Shampoo your hair	0	99999			99999
Par 2, Week 24, Cut your meat	0	99999			99999
Par 2, Week 24, Lift a Full Cup/Glass to mouth	0	99999			99999
Par 2, Week 24, Open a New Milk Carton	0	99999			99999
Par 2, Week 24, Open car doors	0	99999			99999
Par 2, Week 24, Open Jars Previously Opened	0	99999			99999
Par 2, Week 24, Turn Faucets On And Off	0	99999			99999
Par 2, Week 24, Get On and Off The Toilet	0	99999			99999
Par 2, Week 24, Take a Tub Bath	0	99999			99999
Par 2, Week 24, Wash and Dry Your Body	0	99999			99999
Par 2, Week 24, Bend Down Pick Up Clothing-Floor	0	99999			99999
Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head	1	99999			99999
Par 2, Week 24, Climb Up Five Steps	0	99999			99999
Par 2, Week 24, Walk Outdoors on Flat Ground	0	99999			99999
Par 2, Day 344, Able to Do Chores	1	99999			99999
Par 2, Day 344, Get In and Out of a car	0	99999			99999
Par 2, Day 344, Run Errands and Shop	0	99999			99999
Par 2, Day 344, Get In and Out of Bed	0	99999			99999
Par 2, Day 344, Stand Up From a Straight	0	99999			99999
Par 2, Day 344, Dress yourself	0	99999			99999
Par 2, Day 344, Shampoo your hair	0	99999			99999
Par 2, Day 344, Cut your meat	0	99999			99999
Par 2, Day 344, Lift a Full Cup/Glass to mouth	0	99999			99999
Par 2, Day 344, Open a New Milk Carton	1	99999			99999
Par 2, Day 344, Open car doors	0	99999			99999
Par 2, Day 344,Open Jars Previously Opened	0	99999			99999
Par 2, Day 344, Turn Faucets On And Off	0	99999			99999
Par 2, Day 344, Get On and Off The Toilet	0	99999			99999
Par 2, Day 344, Take a Tub Bath	3	99999			99999
Par 2, Day 344, Wash and Dry Your Body	0	99999			99999
Par 2, Day 344, Bend Down Pick Up Clothing-Floor	0	99999			99999
Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head	1	99999			99999
Par 2, Day 344, Climb Up Five Steps	0	99999			99999
Par 2, Day 344, Walk Outdoors on Flat Ground	0	99999			99999
Par 3, Week 12, Able to Do Chores	99999	0			99999
Par 3, Week 12, Get In and Out of a car	99999	0			99999
Par 3, Week 12, Run Errands and Shop	99999	0			99999
Par 3, Week 12, Get In and Out of Bed	99999	0			99999
Par 3, Week 12, Stand Up From a Straight	99999	0			99999
Par 3, Week 12, Dress yourself	99999	0			99999
Par 3, Week 12, Shampoo your hair	99999	0			99999
Par 3, Week 12, Cut your meat	99999	0			99999
Par 3, Week 12, Lift a Full Cup/Glass to mouth	99999	0			99999
Par 3, Week 12, Open a New Milk Carton	99999	0			99999
Par 3, Week 12, Open car doors	99999	0			99999
Par 3, Week 12, Open Jars Previously Opened	99999	0			99999
Par 3, Week 12, Turn Faucets On And Off	99999	0			99999
Par 3, Week 12, Get On and Off The Toilet	99999	0			99999
Par 3, Week 12, Take a Tub Bath	99999	0			99999
Par 3, Week 12, Wash and Dry Your Body	99999	0			99999
Par 3, Week 12, Bend Down Pick Up Clothing-Floor	99999	0			99999
Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head	99999	0			99999
Par 3, Week 12, Climb Up Five Steps	99999	0			99999
Par 3, Week 12, Walk Outdoors on Flat Ground	99999	0			99999
Par 4, Day 87, Able to Do Chores	99999	99999			1
Par 4, Day 87, Get In and Out of a car	99999	99999			0
Par 4, Day 87, Run Errands and Shop	99999	99999			0
Par 4, Day 87, Get In and Out of Bed	99999	99999			0
Par 4, Day 87, Stand Up From a Straight	99999	99999			0
Par 4, Day 87, Dress yourself	99999	99999			0
Par 4, Day 87, Shampoo your hair	99999	99999			0
Par 4, Day 87, Cut your meat	99999	99999			0
Par 4, Day 87, Lift a Full Cup/Glass to mouth	99999	99999			0
Par 4, Day 87, Open a New Milk Carton	99999	99999			0
Par 4, Day 87, Open Jars Previously Opened	99999	99999			0
Par 4, Day 87, Turn Faucets On And Off	99999	99999			0
Par 4, Day 87, Get On and Off The Toilet	99999	99999			0
Par 4, Day 87, Take a Tub Bath	99999	99999			0
Par 4, Day 87, Wash and Dry Your Body	99999	99999			1
Par 4, Day 87, Bend Down Pick Up Clothing-Floor	99999	99999			0
Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head	99999	99999			1
Par 4, Day 87, Climb Up Five Steps	99999	99999			0
Par 4, Day 87, Walk Outdoors on Flat Ground	99999	99999			0

Notes
[23] - Data for number of participants in sustained remission over time for Part B is presented.
[24] - Data for number of participants in sustained remission over time for Part B is presented.
[25] - Data for number of participants in sustained remission over time for Part B is presented.

No statistical analyses for this end point

Secondary: Part B: HAQDI Score over time for participants who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: HAQDI Score over time for participants who never received 100 mg OL Sirukumab in Part B

End point description

The HAQ-DI indicates the extent of the participant's functional ability during the past week, and was assessed for the subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). The HAQ-DI included 20 questions in 8 categories of functioning – dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 to 3, representing “no difficulty” (0), “some difficulty” (1), “much difficulty” (2), and “unable to do” (3) where higher scores indicating worse disability. The functional areas assesed were: activities, arising, dressing and gooming, eating, grip, hygiene, reach and walking.The score for each of the 8 category scores is taken as the maximum score given to the related questions. If no questions within a given functional area were answered, no score was provided for that category.

End point type

Secondary

End point timeframe

Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12

End point values	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	1	1	3	1
Units: Scores on scale
number (not applicable)
Par 1, Day 29, Able to Do Chores	99999	99999	99999	0	99999
Par 1, Day 29, Get In and Out of a car	99999	99999	99999	0	99999
Par 1, Day 29, Run Errands and Shop	99999	99999	99999	0	99999
Par 1, Day 29, Get In and Out of Bed	99999	99999	99999	0	99999
Par 1, Day 29, Stand Up From a Straight Chair	99999	99999	99999	0	99999
Par 1, Day 29, Dress yourself	99999	99999	99999	0	99999
Par 1, Day 29, Shampoo your hair	99999	99999	99999	0	99999
Par 1, Day 29, Cut your meat	99999	99999	99999	0	99999
Par 1, Day 29, Lift a Full Cup or Glass to Mouth	99999	99999	99999	0	99999
Par 1, Day 29, Open a New Milk Carton	99999	99999	99999	0	99999
Par 1, Day 29, Open car doors	99999	99999	99999	0	99999
Par 1, Day 29, Open Jars Previously Opened	99999	99999	99999	0	99999
Par 1, Day 29, Turn Faucets On And Off	99999	99999	99999	0	99999
Par 1, Day 29, Get On and Off The Toilet	99999	99999	99999	0	99999
Par 1, Day 29, Take a Tub Bath	99999	99999	99999	0	99999
Par 1, Day 29, Wash and Dry Your Body	99999	99999	99999	0	99999
Par 1, Day 29, Bend Down Pick Up Clothing- Floor	99999	99999	99999	0	99999
Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head	99999	99999	99999	0	99999
Par 1, Day 29, Climb Up Five Steps	99999	99999	99999	0	99999
Par 1, Day 29, Walk Outdoors on Flat Ground	99999	99999	99999	0	99999
Par 2, Week 12, Able to Do Chores	99999	99999	99999	0	99999
Par 2, Week 12, Get In and Out of a car	99999	99999	99999	0	99999
Par 2, Week 12, Run Errands and Shop	99999	99999	99999	0	99999
Par 2, Week 12, Get In and Out of Bed	99999	99999	99999	0	99999
Par 2, Week 12, Stand Up From a Straight Chair	99999	99999	99999	0	99999
Par 2, Week 12, Dress yourself	99999	99999	99999	0	99999
Par 2, Week 12, Shampoo your hair	99999	99999	99999	0	99999
Par 2, Week 12, Cut your meat	99999	99999	99999	0	99999
Par 2, Week 12, Lift a Full Cup or Glass to Mouth	99999	99999	99999	0	99999
Par 2, Week 12, Open a New Milk Carton	99999	99999	99999	0	99999
Par 2, Week 12, Open r car doors	99999	99999	99999	0	99999
Par 2, Week 12, Open Jars Previously Opened	99999	99999	99999	0	99999
Par 2, Week 12, Turn Faucets On And Off	99999	99999	99999	0	99999
Par 2, Week 12, Get On and Off The Toilet	99999	99999	99999	0	99999
Par 2, Week 12, Take a Tub Bath	99999	99999	99999	0	99999
Par 2, Week 12, Wash and Dry Your Body	99999	99999	99999	0	99999
Par 2, Week 12, Bend Down Pick Up Clothing- Floor	99999	99999	99999	1	99999
Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head	99999	99999	99999	1	99999
Par 2, Week 12, Climb Up Five Steps	99999	99999	99999	0	99999
Par 2, Week 12, Walk Outdoors on Flat Ground	99999	99999	99999	0	99999
Par 2, Day 113, Able to Do Chores	99999	99999	99999	0	99999
Par 2, Day 113, Get In and Out of a car	99999	99999	99999	1	99999
Par 2, Day 113, Run Errands and Shop	99999	99999	99999	0	99999
Par 2, Day 113, Get In and Out of Bed	99999	99999	99999	0	99999
Par 2, Day 113, Stand Up From a Straight Chair	99999	99999	99999	1	99999
Par 2, Day 113, Dress yourself	99999	99999	99999	0	99999
Par 2, Day 113, Shampoo your hair	99999	99999	99999	0	99999
Par 2, Day 113, Cut your meat	99999	99999	99999	0	99999
Par 2, Day 113, Lift a Full Cup or Glass to Mouth	99999	99999	99999	0	99999
Par 2, Day 113, Open a New Milk Carton	99999	99999	99999	0	99999
Par 2, Day 113, Open car doors	99999	99999	99999	0	99999
Par 2, Day 113, Open Jars Previously Opened	99999	99999	99999	0	99999
Par 2, Day 113, Turn Faucets On And Off	99999	99999	99999	0	99999
Par 2, Day 113, Get On and Off The Toilet	99999	99999	99999	0	99999
Par 2, Day 113, Take a Tub Bath	99999	99999	99999	0	99999
Par 2, Day 113, Wash and Dry Your Body	99999	99999	99999	0	99999
Par 2, Day 113, Bend Down Pick Up Clothing- Floor	99999	99999	99999	0	99999
Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head	99999	99999	99999	1	99999
Par 2, Day 113, Climb Up Five Steps	99999	99999	99999	0	99999
Par 2, Day 113, Walk Outdoors on Flat Ground	99999	99999	99999	0	99999
Par 3, Day 65, Able to Do Chores	99999	99999	99999	0	99999
Par 3, Day 65, Get In and Out of a car	99999	99999	99999	0	99999
Par 3, Day 65, Run Errands and Shop	99999	99999	99999	0	99999
Par 3, Day 65, Get In and Out of Bed	99999	99999	99999	1	99999
Par 3, Day 65, Stand Up From a Straight Chair	99999	99999	99999	1	99999
Par 3, Day 65, Dress yourself	99999	99999	99999	0	99999
Par 3, Day 65, Shampoo your hair	99999	99999	99999	0	99999
Par 3, Day 65, Cut your meat	99999	99999	99999	0	99999
Par 3, Day 65, Lift a Full Cup or Glass to Mouth	99999	99999	99999	0	99999
Par 3, Day 65, Open a New Milk Carton	99999	99999	99999	0	99999
Par 3, Day 65, Open car doors	99999	99999	99999	0	99999
Par 3, Day 65, Open Jars Previously Opened	99999	99999	99999	0	99999
Par 3, Day 65, Turn Faucets On And Off	99999	99999	99999	0	99999
Par 3, Day 65, Get On and Off The Toilet	99999	99999	99999	0	99999
Par 3, Day 65, Take a Tub Bath	99999	99999	99999	0	99999
Par 3, Day 65, Wash and Dry Your Body	99999	99999	99999	0	99999
Par 3, Day 65, Bend Down Pick Up Clothing- Floor	99999	99999	99999	0	99999
Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head	99999	99999	99999	1	99999
Par 3, Day 65, Climb Up Five Steps	99999	99999	99999	0	99999
Par 3, Day 65, Walk Outdoors on Flat Ground	99999	99999	99999	0	99999
Par 4, Week 12, Able to Do Chores	0	99999	99999	99999	99999
Par 4, Week 12, Get In and Out of a car	0	99999	99999	99999	99999
Par 4, Week 12, Run Errands and Shop	0	99999	99999	99999	99999
Par 4, Week 12, Get In and Out of Bed	0	99999	99999	99999	99999
Par 4, Week 12, Stand Up From a Straight Chair	0	99999	99999	99999	99999
Par 4, Week 12, Dress yourself	0	99999	99999	99999	99999
Par 4, Week 12, Shampoo your hair	0	99999	99999	99999	99999
Par 4, Week 12, Cut your meat	0	99999	99999	99999	99999
Par 4, Week 12, Lift a Full Cup or Glass to Mouth	0	99999	99999	99999	99999
Par 4, Week 12, Open a New Milk Carton	0	99999	99999	99999	99999
Par 4, Week 12, Open car doors	0	99999	99999	99999	99999
Par 4, Week 12, Open Jars Previously Opened	0	99999	99999	99999	99999
Par 4, Week 12, Turn Faucets On And Off	0	99999	99999	99999	99999
Par 4, Week 12, Get On and Off The Toilet	0	99999	99999	99999	99999
Par 4, Week 12,Take a Tub Bath	0	99999	99999	99999	99999
Par 4, Week 12, Wash and Dry Your Body	0	99999	99999	99999	99999
Par 4, Week 12, Bend Down Pick Up Clothing- Floor	0	99999	99999	99999	99999
Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head	0	99999	99999	99999	99999
Par 4, Week 12, Climb Up Five Steps	0	99999	99999	99999	99999
Par 4, Week 12, Walk Outdoors on Flat Ground	0	99999	99999	99999	99999
Par 4, Day 373, Able to Do Chores	0	99999	99999	99999	99999
Par 4, Day 373, Get In and Out of a car	0	99999	99999	99999	99999
Par 4, Day 373, Run Errands and Shop	0	99999	99999	99999	99999
Par 4, Day 373, Get In and Out of Bed	0	99999	99999	99999	99999
Par 4, Day 373, Stand Up From a Straight Chair	0	99999	99999	99999	99999
Par 4, Day 373, Dress yourself	0	99999	99999	99999	99999
Par 4, Day 373, Shampoo your hair	0	99999	99999	99999	99999
Par 4, Day 373, Cut your meat	0	99999	99999	99999	99999
Par 4, Day 373, Lift a Full Cup or Glass to Mouth	0	99999	99999	99999	99999
Par 4, Day 373, Open a New Milk Carton	0	99999	99999	99999	99999
Par 4, Day 373, Open car doors	0	99999	99999	99999	99999
Par 4, Day 373, Open Jars Previously Opened	0	99999	99999	99999	99999
Par 4, Day 373, Turn Faucets On And Off	0	99999	99999	99999	99999
Par 4, Day 373, Get On and Off The Toilet	0	99999	99999	99999	99999
Par 4, Day 373,Take a Tub Bath	0	99999	99999	99999	99999
Par 4, Day 373, Wash and Dry Your Body	0	99999	99999	99999	99999
Par 4, Day 373, Bend Down Pick Up Clothing- Floor	0	99999	99999	99999	99999
Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head	0	99999	99999	99999	99999
Par 4, Day 373, Climb Up Five Steps	0	99999	99999	99999	99999
Par 4, Day 373, Walk Outdoors on Flat Ground	0	99999	99999	99999	99999
Par 5, Day 64, Able to Do Chores	0	99999	99999	99999	99999
Par 5, Day 64, Get In and Out of a car	0	99999	99999	99999	99999
Par 5, Day 64, Run Errands and Shop	0	99999	99999	99999	99999
Par 5, Day 64, Get In and Out of Bed	0	99999	99999	99999	99999
Par 5, Day 64, Stand Up From a Straight Chair	0	99999	99999	99999	99999
Par 5, Day 64, Dress yourself	1	99999	99999	99999	99999
Par 5, Day 64, Shampoo your hair	0	99999	99999	99999	99999
Par 5, Day 64, Cut your meat	0	99999	99999	99999	99999
Par 5, Day 64, Lift a Full Cup or Glass to Mouth	0	99999	99999	99999	99999
Par 5, Day 64, Open a New Milk Carton	0	99999	99999	99999	99999
Par 5, Day 64, Open car doors	0	99999	99999	99999	99999
Par 5, Day 64, Open Jars Previously Opened	0	99999	99999	99999	99999
Par 5, Day 64, Turn Faucets On And Off	0	99999	99999	99999	99999
Par 5, Day 64, Get On and Off The Toilet	0	99999	99999	99999	99999
Par 5, Day 64,Take a Tub Bath	0	99999	99999	99999	99999
Par 5, Day 64, Wash and Dry Your Body	0	99999	99999	99999	99999
Par 5, Day 64, Bend Down Pick Up Clothing- Floor	1	99999	99999	99999	99999
Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head	1	99999	99999	99999	99999
Par 5, Day 64, Climb Up Five Steps	1	99999	99999	99999	99999
Par 5, Day 64, Walk Outdoors on Flat Ground	1	99999	99999	99999	99999
Par 6, Day 85 Able to Do Chores	99999	1	99999	99999	99999
Par 6, Day 85, Get In and Out of a car	99999	0	99999	99999	99999
Par 6, Day 85, Run Errands and Shop	99999	0	99999	99999	99999
Par 6, Day 85, Get In and Out of Bed	99999	0	99999	99999	99999
Par 6, Day 85, Stand Up From a Straight Chair	99999	0	99999	99999	99999
Par 6, Day 85, Dress yourself	99999	0	99999	99999	99999
Par 6, Day 85,Shampoo your hair	99999	0	99999	99999	99999
Par 6, Day 85, Cut your meat	99999	0	99999	99999	99999
Par 6, Day 85, Lift a Full Cup or Glass to Mouth	99999	0	99999	99999	99999
Par 6, Day 85, Open a New Milk Carton	99999	0	99999	99999	99999
Par 6, Day 85, Open car doors	99999	0	99999	99999	99999
Par 6, Day 85, Open Jars Previously Opened	99999	1	99999	99999	99999
Par 6, Day 85, Turn Faucets On And Off	99999	0	99999	99999	99999
Par 6, Day 85, Get On and Off The Toilet	99999	0	99999	99999	99999
Par 6, Day 85,Take a Tub Bath	99999	1	99999	99999	99999
Par 6, Day 85, Wash and Dry Your Body	99999	0	99999	99999	99999
Par 6, Day 85, Bend Down Pick Up Clothing- Floor	99999	0	99999	99999	99999
Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head	99999	0	99999	99999	99999
Par 6, Day 85, Climb Up Five Steps	99999	0	99999	99999	99999
Par 6, Day 85, Walk Outdoors on Flat Ground	99999	0	99999	99999	99999
Par 7, Day 169, Able to Do Chores	99999	99999	99999	99999	0
Par 7, Day 169, Get In and Out of a car	99999	99999	99999	99999	0
Par 7, Day 169, Run Errands and Shop	99999	99999	99999	99999	0
Par 7, Day 169, Get In and Out of Bed	99999	99999	99999	99999	0
Par 7, Day 169, Stand Up From a Straight Chair	99999	99999	99999	99999	0
Par 7, Day 169, Dress yourself	99999	99999	99999	99999	0
Par 7, Day 169,Shampoo your hair	99999	99999	99999	99999	0
Par 7, Day 169, Cut your meat	99999	99999	99999	99999	0
Par 7, Day 169, Lift a Full Cup or Glass to Mouth	99999	99999	99999	99999	0
Par 7, Day 169, Open a New Milk Carton	99999	99999	99999	99999	0
Par 7, Day 169, Open car doors	99999	99999	99999	99999	0
Par 7, Day 169, Open Jars Previously Opened	99999	99999	99999	99999	0
Par 7, Day 169, Turn Faucets On And Off	99999	99999	99999	99999	0
Par 7, Day 169, Get On and Off The Toilet	99999	99999	99999	99999	0
Par 7, Day 169,Take a Tub Bath	99999	99999	99999	99999	0
Par 7, Day 169, Wash and Dry Your Body	99999	99999	99999	99999	0
Par 7, Day 169, Bend Down Pick Up Clothing- Floor	99999	99999	99999	99999	0
Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head	99999	99999	99999	99999	0
Par 7, Day 169, Climb Up Five Steps	99999	99999	99999	99999	0
Par 7, Day 169, Walk Outdoors on Flat Ground	99999	99999	99999	99999	0
Par 8, Week 12, Able to Do Chores	99999	99999	0	99999	99999
Par 8, Week 12, Get In and Out of a car	99999	99999	0	99999	99999
Par 8, Week 12, Run Errands and Shop	99999	99999	0	99999	99999
Par 8, Week 12, Get In and Out of Bed	99999	99999	0	99999	99999
Par 8, Week 12, Stand Up From a Straight Chair	99999	99999	0	99999	99999
Par 8, Week 12, Dress yourself	99999	99999	0	99999	99999
Par 8, Week 12,Shampoo your hair	99999	99999	0	99999	99999
Par 8, Week 12, Cut your meat	99999	99999	0	99999	99999
Par 8, Week 12, Lift a Full Cup or Glass to Mouth	99999	99999	0	99999	99999
Par 8, Week 12, Open a New Milk Carton	99999	99999	0	99999	99999
Par 8, Week 12, Open car doors	99999	99999	0	99999	99999
Par 8, Week 12, Open Jars Previously Opened	99999	99999	0	99999	99999
Par 8, Week 12, Turn Faucets On And Off	99999	99999	0	99999	99999
Par 8, Week 12, Get On and Off The Toilet	99999	99999	0	99999	99999
Par 8, Week 12,Take a Tub Bath	99999	99999	0	99999	99999
Par 8, Week 12, Wash and Dry Your Body	99999	99999	0	99999	99999
Par 8, Week 12, Bend Down Pick Up Clothing- Floor	99999	99999	0	99999	99999
Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head	99999	99999	0	99999	99999
Par 8, Week 12, Climb Up Five Steps	99999	99999	0	99999	99999
Par 8, Week 12, Walk Outdoors on Flat Ground	99999	99999	0	99999	99999
Par 8, Day 112, Able to Do Chores	99999	99999	0	99999	99999
Par 8, Day 112, Get In and Out of a car	99999	99999	0	99999	99999
Par 8, Day 112, Run Errands and Shop	99999	99999	0	99999	99999
Par 8, Day 112, Get In and Out of Bed	99999	99999	0	99999	99999
Par 8, Day 112, Stand Up From a Straight Chair	99999	99999	0	99999	99999
Par 8, Day 112, Dress yourself	99999	99999	0	99999	99999
Par 8, Day 112, Shampoo your hair	99999	99999	0	99999	99999
Par 8, Day 112, Cut your meat	99999	99999	0	99999	99999
Par 8, Day 112, Lift a Full Cup or Glass to Mout	99999	99999	0	99999	99999
Par 8, Day 112, Open a New Milk Carton	99999	99999	0	99999	99999
Par 8, Day 112, Open car doors	99999	99999	0	99999	99999
Par 8, Day 112, Open Jars Previously Opened	99999	99999	0	99999	99999
Par 8, Day 112, Turn Faucets On And Off	99999	99999	0	99999	99999
Par 8, Day 112, Get On and Off The Toilet	99999	99999	0	99999	99999
Par 8, Day 112, Take a Tub Bath	99999	99999	0	99999	99999
Par 8, Day 112, Wash and Dry Your Body	99999	99999	0	99999	99999
Par 8, Day 112, Bend Down Pick Up Clothing- Floor	99999	99999	0	99999	99999
Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head	99999	99999	0	99999	99999
Par 8, Day 112, Climb Up Five Steps	99999	99999	0	99999	99999
Par 8, Day 112, Walk Outdoors on Flat Ground	99999	99999	0	99999	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in PtGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in PtGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

The Patient’s Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (“very well) to 10 (“very poor”). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Scores on scale
number (not applicable)
Par 1, Week 2	4.3	99999	99999	99999	99999
Par 1, Week 4	2.3	99999	99999	99999	99999
Par 1, Week 8	-0.2	99999	99999	99999	99999
Par 1, Week 12	4.0	99999	99999	99999	99999
Par 1, Week 16	4.7	99999	99999	99999	99999
Par 1, Week 24	2.2	99999	99999	99999	99999
Par 1, Week 36	0.4	99999	99999	99999	99999
Par 1, Day 339	-0.7	99999	99999	99999	99999
Par 2, Week 4	-1.0	99999	99999	99999	99999
Par 2, Week 8	-0.3	99999	99999	99999	99999
Par 2, Week 12	-0.6	99999	99999	99999	99999
Par 2, Week 16	-0.7	99999	99999	99999	99999
Par 2, Week 24	0.5	99999	99999	99999	99999
Par 2, Week 36	-0.6	99999	99999	99999	99999
Par 2, Week 38	0.9	99999	99999	99999	99999
Par 2, Week 40	-0.3	99999	99999	99999	99999
Par 2, Day 344	-0.7	99999	99999	99999	99999
Par 3,Par 3,, Day 113	99999	99999	2.1	99999	99999
Par 4, Week 4	99999	-1.0	99999	99999	99999
Par 4, Week 8	99999	4.9	99999	99999	99999
Par 4, Week 12	99999	0.4	99999	99999	99999
Par 5, Week 4	99999	99999	99999	2.0	99999
Par 5, Week 8	99999	99999	99999	99999	0.4
Par 5, Week 12	99999	99999	99999	0.2	99999
Par 5, Week 14	99999	99999	99999	1.0	99999
Par 5, Week 16	99999	99999	99999	1.0	99999
Par 5, Day 162	99999	99999	99999	0.8	99999
Par 6, Week 4	99999	99999	99999	-3.1	99999
Par 6, Week 8	99999	99999	99999	-3.2	99999
Par 6, Day 91	99999	99999	99999	-3.5	99999
Par 7, Week 2	99999	99999	99999	99999	-0.7
Par 7, Week 4	99999	99999	99999	99999	0.7
Par 7, Week 8	99999	99999	99999	99999	0.8
Par 7, Day 85	99999	99999	99999	99999	-0.4
Par 8, Week 2	99999	99999	99999	99999	-0.1
Par 8, Week 4	99999	99999	99999	99999	-3.7
Par 8, Day 87	99999	99999	99999	99999	-3.1
Par 6, Week 2	99999	99999	99999	-0.1	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in PtGA score for participants who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in PtGA score for participants who never received 100 mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373

End point values	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone
Number of subjects analysed	2	2	6	4	3
Units: Scores on scale
number (not applicable)
Par 1, Day 30	99999	99999	0.2	99999	99999
Par 2, Day 29	99999	99999	-0.1	99999	99999
Par 3, Day 23	99999	99999	0.0	99999	99999
Par 4, Week 4	99999	99999	-0.2	99999	99999
Par 4, Week 8	99999	99999	0.1	99999	99999
Par 4, Week 12	99999	99999	0.0	99999	99999
Par 4, Day 113	99999	99999	0.0	99999	99999
Par 5, Week 4	99999	99999	0.1	99999	99999
Par 5, Week 8	99999	99999	0.4	99999	99999
Par 5, Day 85	99999	99999	2.3	99999	99999
Par 6, Week 4	99999	99999	-1.0	99999	99999
Par 6, Day 65	99999	99999	0.5	99999	99999
Par 7, Week 4	99999	99999	99999	1.0	99999
Par 7, Week 8	99999	99999	99999	0.0	99999
Par 7, Week 12	99999	99999	99999	0.0	99999
Par 7, Week 16	99999	99999	99999	0.2	99999
Par 7, Week 36	99999	99999	99999	0.2	99999
Par 7, Day 373	99999	99999	99999	0.9	99999
Par 8, Week 4	99999	99999	99999	-0.2	99999
Par 8, Day 64	99999	99999	99999	-0.4	99999
Par 9, Day 29	99999	99999	99999	0.1	99999
Par 10, Week 4	99999	99999	99999	0.0	99999
Par 10, Day 57	99999	99999	99999	-0.3	99999
Par 11, Week 4	99999	99999	99999	99999	-0.1
Par 11, Week 8	99999	99999	99999	99999	0.2
Par 11, Week 12	99999	99999	99999	99999	0.2
Par 11, Week 16	99999	99999	99999	99999	1.2
Par 11, Day 163	99999	99999	99999	99999	0.3
Par 12, Day 4	99999	99999	99999	99999	-0.8
Par 12, Week 8	99999	99999	99999	99999	-0.7
Par 12, Day 85	99999	99999	99999	99999	0.9
Par 12, Week 4	99999	99999	99999	99999	-0.7
Par 12, Day 59	99999	99999	99999	99999	1.0
Par 13, Week 4	-0.4	99999	99999	99999	99999
Par 13, Day 57	-0.9	99999	99999	99999	99999
Par 14, Day 169	-1.1	99999	99999	99999	99999
Par 15, Week 4	99999	-0.3	99999	99999	99999
Par 15, Week 12	99999	-0.3	99999	99999	99999
Par 15, Day 112	99999	-0.1	99999	99999	99999
Par 16, Week 8	99999	0.2	99999	99999	99999
Par 16, Day 85	99999	-0.1	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in PhGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in PhGA score for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

In PhGA was based on “What is physician's assessment of the participant's current disease activity”. PhGA used a 10 cm VAS ranging from 0 (“none”) to 10 (“extremely active”). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Scores on scale
number (not applicable)
Par 1, Week 2	0.0	99999	99999	99999	99999
Par 1, Week 4	-0.5	99999	99999	99999	99999
Par 1, Week 8	-1.2	99999	99999	99999	99999
Par 1, Week 12	-0.6	99999	99999	99999	99999
Par 1, Week 16	-0.9	99999	99999	99999	99999
Par 1, Week 24	-0.6	99999	99999	99999	99999
Par 1, Week 36	-1.1	99999	99999	99999	99999
Par 1, Day 339	-1.2	99999	99999	99999	99999
Par 2, Week 4	0.0	99999	99999	99999	99999
Par 2, Week 8	0.1	99999	99999	99999	99999
Par 2, Week 12	0.4	99999	99999	99999	99999
Par 2, Week 16	0.1	99999	99999	99999	99999
Par 2, Week 24	0.0	99999	99999	99999	99999
Par 2, Week 36	0.1	99999	99999	99999	99999
Par 2, Week 38	0.7	99999	99999	99999	99999
Par 2, Week 40	0.4	99999	99999	99999	99999
Par 2, Day 344	0.2	99999	99999	99999	99999
Par 3, Day 113	99999	99999	-0.2	99999	99999
Par 4, Week 4	99999	-0.2	99999	99999	99999
Par 4, Week 12	99999	0.1	99999	99999	99999
Par 5, Week 4	99999	99999	99999	1.8	99999
Par 5, Week 8	99999	99999	99999	-1.1	99999
Par 5, Week 12	99999	99999	99999	-0.7	99999
Par 5, Week 14	99999	99999	99999	1.5	99999
Par 5, Week 16	99999	99999	99999	-1.1	99999
Par 5, Day 162	99999	99999	99999	-0.4	99999
Par 6, Day 203	99999	99999	99999	7.6	99999
Par 7, Week 2	99999	99999	99999	99999	0.0
Par 7, Week 4	99999	99999	99999	99999	0.1
Par 7, Week 8	99999	99999	99999	99999	0.0
Par 7, Day 85	99999	99999	99999	99999	0.0
Par 8, Week 2	99999	99999	99999	99999	-6.0
Par 8, Week 4	99999	99999	99999	99999	-6.3

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in PhGA score for participants who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in PhGA score for participants who never received 100 mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373

End point values	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone
Number of subjects analysed	2	2	6	4	3
Units: Scores on scale
number (not applicable)
Par 1, Day 30	99999	99999	0.0	99999	99999
Par 2, Day 29	99999	99999	0.1	99999	99999
Par 3, Day 23	99999	99999	0.0	99999	99999
Par 3, Week 12	99999	99999	0.7	99999	99999
Par 4, Day 113	99999	99999	0.0	99999	99999
Par 5, Week 4	99999	99999	-0.3	99999	99999
Par 5, Day 85	99999	99999	0.3	99999	99999
Par 6, Week 4	99999	99999	-0.2	99999	99999
Par 6, Day 65	99999	99999	-0.3	99999	99999
Par 7, Week 4	99999	99999	99999	0.2	99999
Par 7, Week 8	99999	99999	99999	0.0	99999
Par 7, Week 12	99999	99999	99999	0.2	99999
Par 7, Week 16	99999	99999	99999	0.4	99999
Par 7, Week 36	99999	99999	99999	0.2	99999
Par 7, Day 373	99999	99999	99999	0.0	99999
Par 8, Week 4	99999	99999	99999	0.4	99999
Par 8, Day 64	99999	99999	99999	0.1	99999
Par 9, Day 29	99999	99999	99999	0.2	99999
Par 10, Week 4	99999	99999	99999	0.0	99999
Par 10, Day 57	99999	99999	99999	0.1	99999
Par 11, Week 12	99999	99999	99999	99999	0.9
Par 11, Week 16	99999	99999	99999	99999	0.9
Par 11, Day 163	99999	99999	99999	99999	0.4
Par 12, Week 4	99999	99999	99999	99999	-0.1
Par 12, Week 8	99999	99999	99999	99999	0.1
Par 12, Day 85	99999	99999	99999	99999	-0.1
Par 13, Week 4	99999	99999	99999	99999	-0.6
Par 13, Day 59	99999	99999	99999	99999	-0.3
Par 14, Week 4	-0.3	99999	99999	99999	99999
Par 14, Day 57	0.3	99999	99999	99999	99999
Par 15, Day 169	-0.5	99999	99999	99999	99999
Par 16, Week 4	99999	-0.1	99999	99999	99999
Par 16, Week 12	99999	0.0	99999	99999	99999
Par 16, Day 112	99999	0.4	99999	99999	99999
Par 17, Week 8	99999	0.1	99999	99999	99999
Par 17, Day 85	99999	0.2	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: Number of participants with PGIC Score over time who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Number of participants with PGIC Score over time who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1), Days 103 and 271

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Participants
number (not applicable)
Par 1, Day 1: Much Better	1	99999	99999	99999	99999
Par 2, Day 1: Much Better	1	99999	99999	99999	99999
Par 2, Day 271: Worse	1	99999	99999	99999	99999
Par 3, Day 1: Much Better	99999	99999	1	99999	99999
Par 4, Day 1: Much Better	99999	1	99999	99999	99999
Par 5,Day 1: Slightly Better	99999	99999	99999	1	99999
Par 5, Day 103: No change	99999	99999	99999	1	99999
Par 6, Day 1: Better	99999	99999	99999	1	99999
Par 7, Day 1: Much Better	99999	99999	99999	99999	1
Par 8, Day 1: Slightly Better	99999	99999	99999	99999	1

No statistical analyses for this end point

Secondary: Part B: Number of participants with PGIC Score over time who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Number of participants with PGIC Score over time who never received 100 mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1)

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: Participants
number (not applicable)
Par 1, Day 1: No change	99999	1	99999	99999	99999
Par 2, Day 1: Much Better	99999	1	99999	99999	99999
Par 3, Day 1: Much Better	99999	1	99999	99999	99999
Par 4, Day 1: Much Better	99999	1	99999	99999	99999
Par 5, Day 1: Better	99999	1	99999	99999	99999
Par 6, Day 1: Much Better	99999	1	99999	99999	99999
Par 7, Day 1: Much Better	99999	99999	1	99999	99999
Par 8, Day 1: Better	99999	99999	1	99999	99999
Par 9, Day 1: Much Better	99999	99999	1	99999	99999
Par 10, Day 1: Better	99999	99999	1	99999	99999
Par 11, Day 1: Much Better	99999	99999	99999	1	99999
Par 12, Day 1: Much Better	99999	99999	99999	1	99999
Par 13, Day 1: Better	99999	99999	99999	1	99999
Par 14, Day 1: Better	99999	99999	99999	99999	1
Par 15, Day 1: Much Better	99999	99999	99999	99999	1
Par 16, Day 1: Much Better	99999	99999	99999	99999	1
Par 17, Day 1: Much Better	1	99999	99999	99999	99999
Par 18, Day 1: Much Better	1	99999	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in CRP over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in CRP over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Milligram per liter (mg/L)
arithmetic mean (standard deviation)
Week 2, n=1,1,0,1,2	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 2.970
Week 4, n=2,1,1,2,2	99999 ± 0.000	99999 ± 99999	99999 ± 99999	99999 ± 1.909	99999 ± 2.828
Week 8, n=2,1,1,2,1	99999 ± 0.000	99999 ± 99999	99999 ± 99999	99999 ± 6.010	99999 ± 99999
Week 12, n=2,1,1,1,0	99999 ± 0.000	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 14, n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 16, n=2,0,0,1,0	99999 ± 0.424	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 24, n=2,0,0,0,0	99999 ± 2.546	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 36, n=2,0,0,0,0	99999 ± 0.849	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 38, n=1,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 40, n=1,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in CRP over time for participants who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in CRP over time for participants who never received 100 mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: mg/L
arithmetic mean (standard deviation)
Week 4, n=3,3,2,1,2	99999 ± 1.202	99999 ± 0.361	99999 ± 0.252	99999 ± 0.071	99999 ± 99999
Week 8, n=2,1,2,0,2	99999 ± 0.636	99999 ± 0.778	99999 ± 99999	99999 ± 0.000	99999 ± 99999
Week 12, n=1,1,1,1,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 16, n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 24, n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 36, n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in ESR over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in ESR over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Millimeter per hour (mm/h)
arithmetic mean (standard deviation)
Week 2, n=1,1,0,1,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 4, n=2,1,1,2,2	99999 ± 2.12	99999 ± 99999	99999 ± 99999	99999 ± 16.97	99999 ± 31.82
Week 8, n=2,1,0,2,1	99999 ± 7.07	99999 ± 99999	99999 ± 99999	99999 ± 15.56	99999 ± 99999
Week 12, n=2,1,1,1,0	99999 ± 1.41	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 14, n=0,0,0,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 16, n=2,0,0,1,0	99999 ± 2.12	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 24, n=2,0,0,0,0	± 0.71	± 99999	± 99999	± 99999	± 99999
Week 36, n=2,0,0,0,0	99999 ± 11.31	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 38, n=1,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 40, n=1,0,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in ESR over time for participants who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in ESR over time for participants who never received 100 mg OL Sirukumab in Part B

End point description

End point type

Secondary

End point timeframe

Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: mm/h
arithmetic mean (standard deviation)
Week 36, n=0,1,0,0,0	99999 ± 99999	99999 ± 5.03	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 4, n=3,3,3,1,2	99999 ± 5.66	99999 ± 5.03	99999 ± 1.53	99999 ± 1.00	99999 ± 99999
Week 8, n=2,1,3,0,2	99999 ± 2.83	99999 ± 7.07	99999 ± 99999	99999 ± 0.00	99999 ± 99999
Week 12, n=1,1,1,1,1	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 16, n=0,1,1,1,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999
Week 24, n=0,1,0,0,0	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who received at least one dose of 100 mg OL Sirukumab in Part B

End point description

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent’s self-rated health on a vertical line, VAS where the endpoints are ‘Best imaginable health state’ and ‘Worst imaginable health state’. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24

End point values	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:Placebo SC q2w + 6 month prednisone	PartB:Placebo SC q2w + 12 month prednisone
Number of subjects analysed	2	1	1	2	2
Units: Scores on scale
number (not applicable)
Par 2, Day 344	-1	99999	99999	99999	99999
Par 3, Day 113	99999	99999	1	99999	99999
Par 4, Week 12	99999	-4	99999	99999	99999
Par 5, Week 12	99999	99999	99999	9	99999
Par 5, Day 162	99999	99999	99999	-15	99999
Par 6, Day 91	99999	99999	99999	20	99999
Par 7, Day 85	99999	99999	99999	99999	4
Par 8, Day 87	99999	99999	99999	99999	21
Par 1, Week 12	-12	99999	99999	99999	99999
Par 1, Week 24	1	99999	99999	99999	99999
Par 1, Day 339	8	99999	99999	99999	99999
Par 2, Week 12	3	99999	99999	99999	99999
Par 2, Week 24	14	99999	99999	99999	99999

No statistical analyses for this end point

Secondary: Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who never received 100 mg OL Sirukumab in Part B

Top of page

End point title

Part B: Change from Baseline in EQ-5D-5L VAS over time for participants who never received 100 mg OL Sirukumab in Part B

End point description

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent’s self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12

End point values	PartB:Placebo SC q2w + 12 month prednisone	PartB:SIR 100 mg SC q2w+6 month prednisone	PartB:SIR 100 mg SC q2w+3 month prednisone	PartB:SIR 50 mg SC q4w+6 month prednisone	PartB:Placebo SC q2w + 6 month prednisone
Number of subjects analysed	2	6	4	3	3
Units: Scores on scale
number (not applicable)
Par 5, Day 85	99999	-1	99999	99999	99999
Par 6, Day 65	99999	20	99999	99999	99999
Par 7, Week 12	99999	99999	4	99999	99999
Par 7, Day 373	99999	99999	8	99999	99999
Par 8, Day 64	99999	99999	-2	99999	99999
Par 9, Day 29	99999	99999	-1	99999	99999
Par 10, Day 57	99999	99999	5	99999	99999
Par 11, Week 12	99999	99999	99999	-10	99999
Par 11, Day 163	99999	99999	99999	-12	99999
Par 12, Day 85	99999	99999	99999	-8	99999
Par 13, Day 59	99999	99999	99999	10	99999
Par 14, Day 57	99999	99999	99999	99999	-42
Par 16, Day 169	99999	99999	99999	99999	62
Par 17, Week 12	9	99999	99999	99999	99999
Par 17, Day 112	7	99999	99999	99999	99999
Par 18, Day 85	-4	99999	99999	99999	99999
Par 1, Day 30	99999	2	99999	99999	99999
Par 2, Day 29	99999	0	99999	99999	99999
Par 3, Day 23	99999	1	99999	99999	99999
Par 4, Week 12	99999	-2	99999	99999	99999
Par 4, Day 113	99999	-47	99999	99999	99999

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 104 in Part B.

Adverse event reporting additional description

Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.1

Reporting group title

Part A:SIR 100 mg SC q2w+6 month prednisone

Reporting group description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen

Reporting group title

Part A:SIR 100 mg SC q2w+3 month prednisone

Reporting group description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Reporting group title

Part A: SIR 50 mg SC q4w+6 month prednisone

Reporting group description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen

Reporting group title

Part A:Placebo SC q2w + 6 month prednisone

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen

Reporting group title

Part A:Placebo SC q2w + 12 month prednisone

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen

Reporting group title

Part B:SIR 100 mg SC q2w+6 month Prednisone+100mg OL SIR

Reporting group description

Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

Reporting group title

Part B:SIR 100 mg SC q2w+3 month Prednisone+100mg OL SIR

Reporting group description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

Reporting group title

Part B:SIR 50 mg SC q4w+6 month Prednisone+100mg OL SIR

Reporting group description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

Reporting group title

Part B:Placebo SC q2w + 6 month Prednisone+100mg OL SIR

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

Reporting group title

Part B:Placebo SC q2w + 12 month Prednisone+100mg OL SIR

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.

Reporting group title

Part B:SIR 100 mg SC q2w+6 month Prednisone/ No 100mg OL SIR

Reporting group description

Reporting group title

Part B:SIR 100 mg SC q2w+3 month Prednisone/ No 100mg OL SIR

Reporting group description

Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

Reporting group title

Part B:SIR 50 mg SC q4w+6 month Prednisone/ No 100mg OL SIR

Reporting group description

Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

Reporting group title

Part B:Placebo SC q2w + 6 month Prednisone/ No 100mg OL SIR

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

Reporting group title

Part B:Placebo SC q2w + 12 month Prednisone/ No 100mg OL SIR

Reporting group description

Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.

Part A:SIR 100 mg SC q2w+6 month prednisone

Part A:SIR 100 mg SC q2w+3 month prednisone

Part A: SIR 50 mg SC q4w+6 month prednisone

Part A:Placebo SC q2w + 6 month prednisone

Part A:Placebo SC q2w + 12 month prednisone

Part B:SIR 100 mg SC q2w+6 month Prednisone+100mg OL SIR

Part B:SIR 100 mg SC q2w+3 month Prednisone+100mg OL SIR

Part B:SIR 50 mg SC q4w+6 month Prednisone+100mg OL SIR

Part B:Placebo SC q2w + 6 month Prednisone+100mg OL SIR

Part B:Placebo SC q2w + 12 month Prednisone+100mg OL SIR

Part B:SIR 100 mg SC q2w+6 month Prednisone/ No 100mg OL SIR

Part B:SIR 100 mg SC q2w+3 month Prednisone/ No 100mg OL SIR

Part B:SIR 50 mg SC q4w+6 month Prednisone/ No 100mg OL SIR

Part B:Placebo SC q2w + 6 month Prednisone/ No 100mg OL SIR

Part B:Placebo SC q2w + 12 month Prednisone/ No 100mg OL SIR

Total subjects affected by serious adverse events

subjects affected / exposed

8 / 42 (19.05%)

6 / 39 (15.38%)

6 / 26 (23.08%)

5 / 27 (18.52%)

6 / 27 (22.22%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma in situ

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Squamous cell carcinoma

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Temporal arteritis

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

1 / 27 (3.70%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Asthenia

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chest discomfort

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Bronchiectasis

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Alcohol withdrawal syndrome

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Brain contusion

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fall

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rib fracture

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

1 / 26 (3.85%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal compression fracture

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subdural haematoma

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Angina pectoris

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial fibrillation

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Headache

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

2 / 26 (7.69%)

1 / 27 (3.70%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Transient ischaemic attack

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

Vertigo

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

1 / 26 (3.85%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Retinal artery occlusion

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Large intestine polyp

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Hepatitis cholestatic

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Hypersensitivity vasculitis

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

1 / 26 (3.85%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin ulcer

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Nephrolithiasis

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

1 / 26 (3.85%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

1 / 27 (3.70%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal osteoarthritis

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

1 / 26 (3.85%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Synovial cyst

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

1 / 27 (3.70%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Tenosynovitis

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Clostridium difficile colitis

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

1 / 26 (3.85%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Escherichia sepsis

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metapneumovirus infection

subjects affected / exposed

1 / 42 (2.38%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

1 / 26 (3.85%)

1 / 27 (3.70%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vestibular neuronitis

subjects affected / exposed

0 / 42 (0.00%)

1 / 39 (2.56%)

0 / 26 (0.00%)

0 / 27 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Electrolyte imbalance

subjects affected / exposed

0 / 42 (0.00%)

0 / 39 (0.00%)

0 / 26 (0.00%)

0 / 27 (0.00%)

1 / 27 (3.70%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 6 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Part A:SIR 100 mg SC q2w+6 month prednisone	Part A:SIR 100 mg SC q2w+3 month prednisone	Part A: SIR 50 mg SC q4w+6 month prednisone	Part A:Placebo SC q2w + 6 month prednisone	Part A:Placebo SC q2w + 12 month prednisone	Part B:SIR 100 mg SC q2w+6 month Prednisone+100mg OL SIR	Part B:SIR 100 mg SC q2w+3 month Prednisone+100mg OL SIR	Part B:SIR 50 mg SC q4w+6 month Prednisone+100mg OL SIR	Part B:Placebo SC q2w + 6 month Prednisone+100mg OL SIR	Part B:Placebo SC q2w + 12 month Prednisone+100mg OL SIR	Part B:SIR 100 mg SC q2w+6 month Prednisone/ No 100mg OL SIR	Part B:SIR 100 mg SC q2w+3 month Prednisone/ No 100mg OL SIR	Part B:SIR 50 mg SC q4w+6 month Prednisone/ No 100mg OL SIR	Part B:Placebo SC q2w + 6 month Prednisone/ No 100mg OL SIR	Part B:Placebo SC q2w + 12 month Prednisone/ No 100mg OL SIR
Total subjects affected by non serious adverse events
subjects affected / exposed	41 / 42 (97.62%)	36 / 39 (92.31%)	25 / 26 (96.15%)	26 / 27 (96.30%)	24 / 27 (88.89%)	2 / 2 (100.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)	2 / 2 (100.00%)	2 / 2 (100.00%)	4 / 6 (66.67%)	3 / 4 (75.00%)	2 / 3 (66.67%)	1 / 3 (33.33%)	0 / 2 (0.00%)
Vascular disorders
Hypertension
subjects affected / exposed	4 / 42 (9.52%)	2 / 39 (5.13%)	4 / 26 (15.38%)	0 / 27 (0.00%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	3	4	0	2	0	0	0	0	0	0	1	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	3 / 42 (7.14%)	1 / 39 (2.56%)	1 / 26 (3.85%)	1 / 27 (3.70%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	2	1	1	2	0	0	0	0	0	0	0	0	0	0
Fatigue
subjects affected / exposed	2 / 42 (4.76%)	3 / 39 (7.69%)	4 / 26 (15.38%)	2 / 27 (7.41%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	41	5	2	0	0	0	0	0	0	0	0	1	0	0
Injection site erythema
subjects affected / exposed	9 / 42 (21.43%)	4 / 39 (10.26%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	29	4	5	0	0	1	0	0	0	0	0	0	0	0	0
Injection site pain
subjects affected / exposed	2 / 42 (4.76%)	3 / 39 (7.69%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	3	6	0	0	0	0	0	0	0	0	0	0	0	0
Injection site pruritus
subjects affected / exposed	3 / 42 (7.14%)	4 / 39 (10.26%)	1 / 26 (3.85%)	0 / 27 (0.00%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	19	7	2	0	0	3	0	0	0	0	0	0	0	0	0
Injection site reaction
subjects affected / exposed	6 / 42 (14.29%)	2 / 39 (5.13%)	4 / 26 (15.38%)	0 / 27 (0.00%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	9	6	13	0	0	1	0	0	0	0	0	0	0	0	0
Injection site swelling
subjects affected / exposed	4 / 42 (9.52%)	4 / 39 (10.26%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	6	4	8	0	0	1	0	0	0	0	0	0	0	0	0
Injection site warmth
subjects affected / exposed	1 / 42 (2.38%)	2 / 39 (5.13%)	1 / 26 (3.85%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	2	1	0	0	0	0	0	0	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	5 / 42 (11.90%)	8 / 39 (20.51%)	3 / 26 (11.54%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	14	4	0	0	0	0	0	0	0	0	0	0	0	0
Pain
subjects affected / exposed	1 / 42 (2.38%)	1 / 39 (2.56%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	11	2	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	8 / 42 (19.05%)	2 / 39 (5.13%)	2 / 26 (7.69%)	2 / 27 (7.41%)	3 / 27 (11.11%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	8	3	2	3	5	0	0	0	0	1	0	0	0	0	0
Dyspnoea
subjects affected / exposed	2 / 42 (4.76%)	2 / 39 (5.13%)	1 / 26 (3.85%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	8	1	0	2	0	0	0	0	0	0	0	0	0	0
Epistaxis
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	2	2	0	0	0	0	0	0	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	4 / 42 (9.52%)	1 / 39 (2.56%)	4 / 26 (15.38%)	0 / 27 (0.00%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	1	4	0	1	0	0	0	0	0	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	2 / 26 (7.69%)	1 / 27 (3.70%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	4	2	1	1	0	0	0	0	0	0	0	0	0	0
Nervousness
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
C-reactive protein abnormal
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	2 / 27 (7.41%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	3	0	1	0	0	0	0	0	0	0	0	0
Low density lipoprotein increased
subjects affected / exposed	1 / 42 (2.38%)	0 / 39 (0.00%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	0	2	0	0	0	0	0	0	0	1	0	0	0	0
Platelet count decreased
subjects affected / exposed	1 / 42 (2.38%)	0 / 39 (0.00%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	1 / 42 (2.38%)	1 / 39 (2.56%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	1	2	0	0	0	0	0	0	0	0	0	0	0	0
Contusion
subjects affected / exposed	3 / 42 (7.14%)	1 / 39 (2.56%)	2 / 26 (7.69%)	2 / 27 (7.41%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	1	2	2	0	0	0	0	0	0	0	0	0	0	0
Fall
subjects affected / exposed	4 / 42 (9.52%)	2 / 39 (5.13%)	0 / 26 (0.00%)	0 / 27 (0.00%)	3 / 27 (11.11%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	8	2	0	0	3	0	0	0	0	0	0	0	0	0	0
Joint dislocation
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0
Ligament sprain
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	2 / 27 (7.41%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0
Limb injury
subjects affected / exposed	4 / 42 (9.52%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Road traffic accident
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Tendon rupture
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Foot fracture
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Laceration
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Limb traumatic amputation
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Procedural pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	3 / 42 (7.14%)	4 / 39 (10.26%)	2 / 26 (7.69%)	1 / 27 (3.70%)	3 / 27 (11.11%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	5	3	1	3	1	0	0	0	0	0	0	0	0	0
Headache
subjects affected / exposed	13 / 42 (30.95%)	7 / 39 (17.95%)	8 / 26 (30.77%)	7 / 27 (25.93%)	8 / 27 (29.63%)	0 / 2 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	20	14	16	7	13	0	0	1	1	0	0	0	1	0	0
Hypoaesthesia
subjects affected / exposed	1 / 42 (2.38%)	2 / 39 (5.13%)	0 / 26 (0.00%)	1 / 27 (3.70%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	3	0	4	0	0	0	0	0	0	0	0	0	0	0
Paraesthesia
subjects affected / exposed	1 / 42 (2.38%)	2 / 39 (5.13%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Tremor
subjects affected / exposed	3 / 42 (7.14%)	3 / 39 (7.69%)	1 / 26 (3.85%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	3	1	0	0	0	0	0	0	0	0	0	0	0	0
Syncope
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	1 / 42 (2.38%)	4 / 39 (10.26%)	1 / 26 (3.85%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	5	1	0	0	0	0	0	0	0	0	0	0	0	0
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	1 / 42 (2.38%)	1 / 39 (2.56%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	1	3	0	0	0	0	0	0	0	0	0	0	0	0
Eye disorders
Blepharitis
subjects affected / exposed	0 / 42 (0.00%)	2 / 39 (5.13%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Cataract
subjects affected / exposed	0 / 42 (0.00%)	1 / 39 (2.56%)	1 / 26 (3.85%)	1 / 27 (3.70%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	1	1	3	0	0	0	0	0	0	0	0	0	0
Eye pain
subjects affected / exposed	1 / 42 (2.38%)	0 / 39 (0.00%)	1 / 26 (3.85%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	0	1	0	2	0	0	0	0	0	0	0	0	0	0
Chalazion
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 42 (0.00%)	2 / 39 (5.13%)	3 / 26 (11.54%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	2	3	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal pain upper
subjects affected / exposed	2 / 42 (4.76%)	2 / 39 (5.13%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	4	3	0	0	0	0	0	0	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	5 / 42 (11.90%)	2 / 39 (5.13%)	5 / 26 (19.23%)	2 / 27 (7.41%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	2	12	3	0	0	0	0	0	0	0	0	0	0	0
Faeces discoloured
subjects affected / exposed	0 / 42 (0.00%)	2 / 39 (5.13%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastritis
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	1 / 26 (3.85%)	2 / 27 (7.41%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 42 (0.00%)	1 / 39 (2.56%)	2 / 26 (7.69%)	2 / 27 (7.41%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	2	2	0	0	0	0	3	0	0	0	0	0	0
Haemorrhoids
subjects affected / exposed	0 / 42 (0.00%)	2 / 39 (5.13%)	0 / 26 (0.00%)	1 / 27 (3.70%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	3	0	1	1	0	0	0	0	0	0	0	0	0	0
Nausea
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	2 / 26 (7.69%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	2	2	0	2	0	0	0	0	0	0	0	1	0	0
Toothache
subjects affected / exposed	4 / 42 (9.52%)	1 / 39 (2.56%)	1 / 26 (3.85%)	2 / 27 (7.41%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	1	1	2	0	0	0	0	0	0	0	0	0	0	0
Abdominal hernia
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Eructation
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Noninfective gingivitis
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Rectal haemorrhage
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Dyspepsia
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Abdominal distension
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	2 / 26 (7.69%)	0 / 27 (0.00%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	2	2	0	1	0	0	0	0	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	5 / 42 (11.90%)	1 / 39 (2.56%)	1 / 26 (3.85%)	1 / 27 (3.70%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	5	5	1	1	0	0	0	0	0	0	0	0	0	0	0
Night sweats
subjects affected / exposed	2 / 42 (4.76%)	1 / 39 (2.56%)	2 / 26 (7.69%)	1 / 27 (3.70%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	1	2	1	0	0	0	0	0	0	0	0	0	0	0
Pruritus
subjects affected / exposed	1 / 42 (2.38%)	0 / 39 (0.00%)	2 / 26 (7.69%)	1 / 27 (3.70%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	0	2	1	1	0	0	0	1	0	0	0	0	0	0
Swelling face
subjects affected / exposed	1 / 42 (2.38%)	1 / 39 (2.56%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	1	2	0	0	0	0	0	0	0	0	0	0	0	0
Macule
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Rash
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0
Purpura
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Endocrine disorders
Cushingoid
subjects affected / exposed	1 / 42 (2.38%)	2 / 39 (5.13%)	0 / 26 (0.00%)	1 / 27 (3.70%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	2	0	1	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	5 / 42 (11.90%)	4 / 39 (10.26%)	5 / 26 (19.23%)	1 / 27 (3.70%)	4 / 27 (14.81%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	7	36	6	1	6	0	0	0	0	0	0	0	1	0	0
Back pain
subjects affected / exposed	7 / 42 (16.67%)	3 / 39 (7.69%)	3 / 26 (11.54%)	2 / 27 (7.41%)	4 / 27 (14.81%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	7	9	5	2	5	0	0	0	0	0	0	0	0	0	0
Bursitis
subjects affected / exposed	1 / 42 (2.38%)	2 / 39 (5.13%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Muscle spasms
subjects affected / exposed	3 / 42 (7.14%)	5 / 39 (12.82%)	3 / 26 (11.54%)	1 / 27 (3.70%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	6	6	3	2	0	0	0	0	0	0	0	0	0	0	0
Muscular weakness
subjects affected / exposed	1 / 42 (2.38%)	3 / 39 (7.69%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	4	0	0	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal chest pain
subjects affected / exposed	2 / 42 (4.76%)	2 / 39 (5.13%)	2 / 26 (7.69%)	1 / 27 (3.70%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	3	2	1	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal pain
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	1 / 26 (3.85%)	2 / 27 (7.41%)	4 / 27 (14.81%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	7	2	2	5	0	0	0	0	0	0	0	0	0	0
Myalgia
subjects affected / exposed	0 / 42 (0.00%)	1 / 39 (2.56%)	2 / 26 (7.69%)	0 / 27 (0.00%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	2	0	1	0	0	0	0	0	0	0	0	0	0
Neck pain
subjects affected / exposed	1 / 42 (2.38%)	2 / 39 (5.13%)	1 / 26 (3.85%)	0 / 27 (0.00%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	5	1	0	0	1	0	0	0	0	0	0	0	0	0
Osteoarthritis
subjects affected / exposed	2 / 42 (4.76%)	1 / 39 (2.56%)	0 / 26 (0.00%)	0 / 27 (0.00%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	1	0	0	3	0	0	0	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	3 / 26 (11.54%)	2 / 27 (7.41%)	3 / 27 (11.11%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	6	5	2	3	0	0	0	0	0	0	0	0	0	0
Pain in jaw
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	0 / 26 (0.00%)	0 / 27 (0.00%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	3	0	0	1	0	0	0	0	0	0	0	0	0	0
Polymyalgia rheumatica
subjects affected / exposed	1 / 42 (2.38%)	1 / 39 (2.56%)	0 / 26 (0.00%)	1 / 27 (3.70%)	2 / 27 (7.41%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	1	0	1	2	0	0	0	0	0	1	0	0	0	0
Synovial cyst
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Intervertebral disc protrusion
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	1 / 42 (2.38%)	3 / 39 (7.69%)	0 / 26 (0.00%)	2 / 27 (7.41%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	3	0	2	1	0	0	0	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	1 / 42 (2.38%)	2 / 39 (5.13%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 2 (0.00%)
occurrences all number	1	2	2	0	0	0	0	0	0	1	0	0	0	1	0
Nasopharyngitis
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	3 / 26 (11.54%)	1 / 27 (3.70%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	2	4	1	1	0	0	0	0	0	1	0	1	0	0
Onychomycosis
subjects affected / exposed	0 / 42 (0.00%)	2 / 39 (5.13%)	0 / 26 (0.00%)	0 / 27 (0.00%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	3	0	0	1	0	0	0	0	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 42 (0.00%)	2 / 39 (5.13%)	1 / 26 (3.85%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 39 (0.00%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	3 / 42 (7.14%)	3 / 39 (7.69%)	2 / 26 (7.69%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	3	3	2	0	0	0	0	0	0	0	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	2 / 42 (4.76%)	8 / 39 (20.51%)	2 / 26 (7.69%)	4 / 27 (14.81%)	1 / 27 (3.70%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	2	8	2	5	1	0	0	0	0	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	3 / 42 (7.14%)	2 / 39 (5.13%)	2 / 26 (7.69%)	2 / 27 (7.41%)	4 / 27 (14.81%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	4	2	2	2	10	0	0	0	0	1	0	0	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Metabolism and nutrition disorders
Hypercholesterolaemia
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 6 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Gout
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 6 (16.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Vitamin D deficiency
subjects affected / exposed	0 / 42 (0.00%)	0 / 39 (0.00%)	0 / 26 (0.00%)	0 / 27 (0.00%)	0 / 27 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 6 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

15 Oct 2015

Amendment No. 1: Protocol has been updated to clarify the secondary objectives and endpoints of characterization of sustained remission in Parts A and B, collection of patient and physician reported outcomes, including correction of the version of the EQ-5D version that will be administered and pain assessment using a numeric rating scale. Further clarifications have been included in updates to the potential signs and symptoms of GCA, prednisone use during screening and taper initiation, participant eligibility for receiving open-label sirukumab in Part B and investigator consideration of the individual participant benefit-risk of continuing sirukumab in Part B. This amendment includes additional information on risk mitigation for GI perforations and serious allergic/hypersensitivity events. The inclusion criteria for GCA diagnostic criteria for temporal artery biopsy and imaging and symptoms of active GCA have been updated. Other changes include removal of restrictions on the use of NSAIDs, clarification of circumstances requiring discontinuation of study treatment but not study withdrawal, and circumstances in which subjects may withdraw from the study. The Time and Events table has been updated and corrections included. Other additions include guidance to investigators related to treatment of glucocorticoid-induced osteoporosis. Clarification of protocol-specified exploratory biomarkers and optional exploratory biomarkers, updated information on the study number for the exploratory imaging sub-study, randomization system and correction of typographical errors.

31 Mar 2016

Amendment No. 2: Amendment has been updated to include the assessment of the utility of ultrasound imaging as an indicator of disease activity in an exploratory cohort of participants. Other modifications include updates to the inclusion criteria for diagnosis of GCA to allow for diagnosis by ultrasound imaging in sites qualified to participate in the ultrasound imaging portion of the study, to further clarify features consistent with GCA or PMR flares, and to clarify requirements for the prednisone dose at Screening. The inclusion criteria have also been amended to include the acceptability of a single view of chest radiographs if consistent with local guidelines. Updated information on the pre-filled syringes has been included. Other modifications include the clarification that the daily prednisone dose should be taken in a single daily administration in the morning. Country-specific requirements have been included for Germany, the Netherlands, and Australia and New Zealand. These include a requirement to discontinue study drug administration in the event of a serious infection (Germany), a requirement for participants to discontinue the study at the conclusion of Part A after completing the 16-week follow up phase (the Netherlands) and a requirement to notify investigators when the value of the ESR result is > 40 mm/hr or has increased > 10 mm/hr from baseline or previous result (Australia and New Zealand).

17 Nov 2016

Amendment No. 3: Amendment has been updated to include the implementation of the Columbia-Suicide Severity Rating Scale to prospectively monitor suicidal ideation and behavior. Other modifications include revision of the endpoints for the exploratory imaging cohort, further clarifications regarding the initiation of the prednisone taper and prednisone sourcing information, and inclusion of malignancies as a potential risk of clinical significance. In addition, a requirement for male contraception and restrictions on sperm donation, amendment of QTc exclusion and stopping criteria, revision of criteria to allow prior anti-IL-6 use if not associated with intolerance or inadequate response, and addition of an exclusion criterion related to suicidality are included. Pregnancy testing is now required at 4-weekly intervals while participants are receiving study drug during Parts A and B and during the 16-week follow up period after drug discontinuation. Additional clarification of reflex testing for hepatitis and tuberculosis testing have been included. Updated information regarding database locks and unblinding and treatment comparisons has also been included.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Part A: Number of participants in sustained remission at Week 52

Primary: Part A: Number of participants in sustained remission at Week 52

Secondary: Part B: Number of participants who remained in sustained remission without requirement for rescue therapy or treatment change at Week 24

Secondary: Part B: Number of participants who remained in sustained remission without requirement for rescue therapy or treatment change at Week 24

Secondary: Part A: Cumulative prednisone dose over time

Secondary: Part A: Cumulative prednisone dose over time

Secondary: Part B: Number of participants in sustained remission over time

Secondary: Part B: Number of participants in sustained remission over time

Secondary: Part A: Time to first disease flare after clinical remission

Secondary: Part A: Time to first disease flare after clinical remission

Secondary: Part B: Time to first disease flare for participants in sustained remission

Secondary: Part B: Time to first disease flare for participants in sustained remission

Secondary: Part A: Number of disease flares over time

Secondary: Part A: Number of disease flares over time

Secondary: Part A: Number of participants with at least one hospitalization for disease flare

Secondary: Part A: Number of participants with at least one hospitalization for disease flare

Secondary: Part A: Number of hospitalizations for disease flare over time

Secondary: Part A: Number of hospitalizations for disease flare over time

Secondary: Part A: Mean 36-item Short Form health survey version 2 (SF-36 v2) acute score over time

Secondary: Part A: Mean 36-item Short Form health survey version 2 (SF-36 v2) acute score over time

Secondary: Part A: Mean EuroQol – 5 dimensions, 5 levels (EQ-5D-5L) Index score over time

Secondary: Part A: Mean EuroQol – 5 dimensions, 5 levels (EQ-5D-5L) Index score over time

Secondary: Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) over time

Secondary: Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) over time

Secondary: Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) scores over time

Secondary: Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) scores over time

Secondary: Part A: Mean Pain Numeric Rating Scale (NRS) scores over time

Secondary: Part A: Mean Pain Numeric Rating Scale (NRS) scores over time

Secondary: Part A: Mean Health Assessment Questionnaire – Disability Index (HAQDI) Score over Time

Secondary: Part A: Mean Health Assessment Questionnaire – Disability Index (HAQDI) Score over Time

Secondary: Part A: Number of participants with Patient Global Impression of Change (PGIC) Score over time

Secondary: Part A: Number of participants with Patient Global Impression of Change (PGIC) Score over time

Secondary: Part A: Mean Patient Global Assessment of disease activity (PtGA) score over time

Secondary: Part A: Mean Patient Global Assessment of disease activity (PtGA) score over time

Secondary: Part A: Mean Physician Global Assessment of disease activity (PhGA) score over time

Secondary: Part A: Mean Physician Global Assessment of disease activity (PhGA) score over time

Secondary: Part A: Change from Baseline in serum C Reactive Protein (CRP) over time

Secondary: Part A: Change from Baseline in serum C Reactive Protein (CRP) over time

Secondary: Part A: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) over time

Secondary: Part A: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) over time

Secondary: Part A: Number of participants with adverse events (AEs), serious AEs (SAEs) and corticosteroid related AEs

Secondary: Part A: Number of participants with adverse events (AEs), serious AEs (SAEs) and corticosteroid related AEs

Secondary: Part A: Change from Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Secondary: Part A: Change from Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Secondary: Part A: Change from Baseline in Pulse Rate

Secondary: Part A: Change from Baseline in Pulse Rate

Secondary: Part A: Change from Baseline in Temperature

Secondary: Part A: Change from Baseline in Temperature

Secondary: Part A: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets

Secondary: Part A: Change from Baseline in hematology parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets

Secondary: Part A: Change from Baseline in hematology parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin

Secondary: Part A: Change from Baseline in hematology parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin

Secondary: Part A: Change from Baseline in hematology parameter-Hematocrit

Secondary: Part A: Change from Baseline in hematology parameter-Hematocrit

Secondary: Part A: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume

Secondary: Part A: Change from Baseline in hematology parameter -Erythrocytes Mean Corpuscular Volume

Secondary: Part A:Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin

Secondary: Part A:Change from Baseline in hematology parameter-Erythrocytes Mean Corpuscular Hemoglobin

Secondary: Part A:Change from Baseline in hematology parameter- Erythrocytes

Secondary: Part A:Change from Baseline in hematology parameter- Erythrocytes

Secondary: Part A: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea

Secondary: Part A: Change from Baseline in clinical chemistry parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Albumin and Protein

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Albumin and Protein

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin

Secondary: Part A: Change from Baseline in clinical chemistry parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin

Secondary: Part A: Mean Serum concentrations of sirukumab

Secondary: Part A: Mean Serum concentrations of sirukumab

Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis