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Clinical Trial Results:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of Tofacitinib (CP-690,550) in Subjects with Active Psoriatic Arthritis and an Inadequate Response to at Least One TNF Inhibitor

Summary
EudraCT number	2013-001368-46
Trial protocol	CZ BE ES SK DE PL
Global end of trial date	04 Apr 2016

Results information
Results version number	v1(current)
This version publication date	05 Mar 2017
First version publication date	05 Mar 2017
Other versions

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

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Trial information

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Sponsor protocol code

A3921125

ISRCTN number

US NCT number

NCT01882439

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer, Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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

04 May 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Apr 2016

Global end of trial reached?

Yes

Global end of trial date

04 Apr 2016

Was the trial ended prematurely?

Main objective of the trial

The main objectives of this trial were to compare efficacy of tofacitinib at doses of 5 mg twice daily (BID) and 10 mg BID versus placebo for treatment of rheumatological signs and symptoms of active psoriatic arthritis (PsA) in subjects who have had an inadequate response in PsA to at least 1 tumor necrosis factor inhibitor (TNFi); to compare physical function status after administration of tofacitinib at doses of 5 mg BID and 10 mg BID versus placebo in subjects with active PsA who have had an inadequate response in PsA to at least 1 TNFi; and to compare the safety and tolerability of tofacitinib at doses of 5 mg BID and 10 mg BID versus placebo in subjects with active PsA who have had an inadequate response in PsA to at least 1 TNFi.

Protection of trial subjects

This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants. The final protocol and any amendments were reviewed and approved by the Institutional Review Board(s) and/or Independent Ethics Committee(s) at each of the investigational centres participating in the study.

Background therapy

During the study, participants remained on a stable dose of 1 conventional synthetic (or non-biologic) Disease-Modifying Anti-Rheumatic Drug, eg, methotrexate, sulfasalazine, leflunomide, or other drug as approved by the Pfizer Study Clinician.

Evidence for comparator

Actual start date of recruitment

22 Aug 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 16

Country: Number of subjects enrolled

Belgium: 17

Country: Number of subjects enrolled

Brazil: 11

Country: Number of subjects enrolled

Czech Republic: 2

Country: Number of subjects enrolled

France: 2

Country: Number of subjects enrolled

Germany: 40

Country: Number of subjects enrolled

Mexico: 45

Country: Number of subjects enrolled

Poland: 54

Country: Number of subjects enrolled

Russian Federation: 31

Country: Number of subjects enrolled

Slovakia: 2

Country: Number of subjects enrolled

Spain: 23

Country: Number of subjects enrolled

Taiwan: 9

Country: Number of subjects enrolled

United Kingdom: 24

Country: Number of subjects enrolled

United States: 118

Worldwide total number of subjects

394

EEA total number of subjects

164

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)

355

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Data through End of Study (Month 6)

Screening details

Of 546 participants screened for entry into the study, 395 were enrolled and randomized, 394 received treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Tofacitinib, 5 mg twice daily

Arm description

Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

CP-690,550

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Tofacitinib 5 mg administered twice daily, with one placebo tablet administered twice daily.

Tofacitinib, 10 mg, twice daily

Arm description

Participants received two 5 mg tofacitinib tablets, twice daily.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

CP-690,550

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Two 5 mg tofacitinib tablets administered twice daily

Placebo/Tofacitinib, 5 mg, twice daily

Arm description

Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

CP-690,550

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Two placebo tablets administered twice daily, up to 3 months. At the end of this period, one 5 mg tofacitinib tablet administered twice daily, and one placebo tablet administered twice daily.

Placebo/Tofacitinib, 10 mg, twice daily

Arm description

Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.

Arm type

Experimental

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

CP-690,550

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Two placebo tablets administered twice daily, up to 3 months. At the end of this period, two 5 mg tofacitinib tablets administered twice daily.

Number of subjects in period 1	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily
Started	131	132	66	65
Completed	122	111	56	56
Not completed	9	21	10	9
Pregnancy	-	1	-	-
No longer willing to participate	1	4	2	3
Adverse event unrelated to study drug	2	2	1	1
Medication error with no associated AE	-	-	2	-
Adverse event related to study drug	3	8	1	2
Protocol deviation	2	2	-	1
Insufficient clinical response	1	4	4	2

Baseline characteristics

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Reporting group title

Tofacitinib, 5 mg twice daily

Reporting group description

Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.

Reporting group title

Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received two 5 mg tofacitinib tablets, twice daily.

Reporting group title

Placebo/Tofacitinib, 5 mg, twice daily

Reporting group description

Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.

Reporting group title

Placebo/Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.

Reporting group values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Total
Number of subjects	131	132	66	65	394
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	119	119	61	56	355
From 65-84 years	12	13	5	9	39
85 years and over	0	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	49.5 ± 12.3	51.3 ± 10.9	48.7 ± 11.2	49.3 ± 14	-
Gender, Male/Female
Units: Subjects
Female	64	74	38	42	218
Male	67	58	28	23	176

End points

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Reporting group title

Tofacitinib, 5 mg twice daily

Reporting group description

Participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet twice daily.

Reporting group title

Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received two 5 mg tofacitinib tablets, twice daily.

Reporting group title

Placebo/Tofacitinib, 5 mg, twice daily

Reporting group description

Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet, twice daily, and one placebo tablet, twice daily.

Reporting group title

Placebo/Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received two placebo tablets, twice daily, up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets, twice daily.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received two placebo tablets twice daily up to 3 months.

Primary: Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Month 3

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End point title

Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Month 3 ^[1]

End point description

ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-reactive protein (CRP).

End point type

Primary

End point timeframe

Month 3

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	131	132	131
Units: Percentage of participants
number (not applicable)	49.62	46.97	23.66

Analysis of ACR20

Comparison groups

Tofacitinib, 5 mg twice daily v Placebo

Number of subjects included in analysis

262

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Large sample approximation

Parameter type

Risk difference (RD)

Point estimate

25.95

Confidence interval

level

95%

sides

2-sided

lower limit

14.72

upper limit

37.19

Variability estimate

Standard error of the mean

Dispersion value

5.73

Analysis of ACR20

Comparison groups

Tofacitinib, 10 mg, twice daily v Placebo

Number of subjects included in analysis

263

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Large sample approximation

Parameter type

Risk difference (RD)

Point estimate

23.31

Confidence interval

level

95%

sides

2-sided

lower limit

12.1

upper limit

34.51

Variability estimate

Standard error of the mean

Dispersion value

5.71

Primary: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3

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End point title

Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3 ^[2]

End point description

The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.

End point type

Primary

End point timeframe

Month 3

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	129	132	131
Units: Units on a scale
least squares mean (standard error)	-0.392 ± 0.04544	-0.354 ± 0.04579	-0.1391 ± 0.04573

Analysis of HAQ-DI

Comparison groups

Tofacitinib, 5 mg twice daily v Placebo

Number of subjects included in analysis

260

Analysis specification

Pre-specified

Analysis type

P-value

< 0.0001

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-0.2529

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3792

upper limit

-0.1266

Variability estimate

Standard error of the mean

Dispersion value

0.06422

Analysis of HAQ-DI

Comparison groups

Tofacitinib, 10 mg, twice daily v Placebo

Number of subjects included in analysis

263

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0009

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-0.215

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3419

upper limit

-0.0881

Variability estimate

Standard error of the mean

Dispersion value

0.06453

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6

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End point title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6

End point description

ACR50 was calculated as a ≥50% improvement from baseline in tender /painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Week 2 and Months 1, 2, 3, 4, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	131	132	66	65	131
Units: Percentage of participants
number (not applicable)
Week 2 (n=8,13,NA,NA,4)	6.11	9.85	9999	9999	3.05
Month 1 (n=23,14,NA,NA,8)	17.56	10.61	9999	9999	6.11
Month 2 (n=33,30,NA,NA,14)	25.19	22.73	9999	9999	10.69
Month 3 (n=39,37,NA,NA,19)	29.77	28.03	9999	9999	14.5
Month 4 (n=50,38,15,21,NA)	38.17	28.79	22.73	32.31	9999
Month 6 (n=50,39,21,23,NA)	38.17	29.55	31.82	35.38	9999

No statistical analyses for this end point

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6

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End point title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6

End point description

ACR70 was calculated as a ≥70% improvement from baseline in tender /painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Week 2 and Months 1, 2, 3, 4, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	131	132	66	65	131
Units: Percentage of participants
number (not applicable)
Week 2 (n=2,3,NA,NA,1)	1.53	2.27	9999	9999	0.76
Month 1 (n=7,5,NA,NA,3)	5.34	3.79	9999	9999	2.29
Month 2 (n=17,13,NA,NA,6)	12.98	9.85	9999	9999	4.58
Month 3 (n=22,19,NA,NA,13)	16.79	14.39	9999	9999	9.92
Month 4 (n=24,20,6,14,NA)	18.32	15.15	9.09	21.54	9999
Month 6 (n=28,19,10,12,NA)	21.37	14.39	15.15	18.46	9999

No statistical analyses for this end point

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6

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End point title

Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6

End point description

ACR20 was calculated as a ≥20% improvement from baseline in tender /painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Week 2 and Months 1, 2, 4, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	131	132	66	65	131
Units: Percentage of participants
number (not applicable)
Week 2 (n=35,38,NA,NA,17)	26.72	28.79	9999	9999	12.98
Month 1 (n=45,56,NA,NA,29)	34.35	42.42	9999	9999	22.14
Month 2 (n=63,63,NA,NA,34)	48.09	47.73	9999	9999	25.95
Month 4 (n=78,69,30,33,NA)	59.54	52.27	45.45	50.77	9999
Month 6 (n=78,65,33,35,NA)	59.54	49.24	50	53.85	9999

No statistical analyses for this end point

Secondary: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6

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End point title

Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6

End point description

End point type

Secondary

End point timeframe

Week 2 and Months 1, 2, 4, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	129	132	66	65	131
Units: Units on scale
least squares mean (standard error)
Week 2 (n=129,130,NA,NA,128)	-0.2198 ± 0.03145	-0.1652 ± 0.0316	9999 ± 9999	9999 ± 9999	-0.0655 ± 0.03133
Month 1 (n=128,129,NA,NA,130)	-0.3229 ± 0.04074	-0.2279 ± 0.04073	9999 ± 9999	9999 ± 9999	-0.1481 ± 0.04038
Month 2 (n=125,126,NA,NA,121)	-0.4114 ± 0.04311	-0.3131 ± 0.04316	9999 ± 9999	9999 ± 9999	-0.162 ± 0.04317
Month 4 (n=125,121,57,58,NA)	-0.4455 ± 0.04489	-0.3305 ± 0.04523	-0.3836 ± 0.06443	-0.3918 ± 0.06418	9999 ± 9999
Month 6 (n=122,112,56,56,NA)	-0.4365 ± 0.04642	-0.3397 ± 0.0472	-0.4808 ± 0.0668	-0.4157 ± 0.06665	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3

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End point title

Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3 ^[3]

End point description

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

End point type

Secondary

End point timeframe

Month 3

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	130	132	131
Units: mg/L
least squares mean (standard error)	-5.4657 ± 1.80096	-5.9156 ± 1.83181	1.0233 ± 1.82879

No statistical analyses for this end point

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3

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End point title

Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3 ^[4]

End point description

Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

End point type

Secondary

End point timeframe

Month 3

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	129	132	131
Units: mm
least squares mean (standard error)	-21.66 ± 2.162	-20.88 ± 2.188	-7.72 ± 2.184

No statistical analyses for this end point

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3

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End point title

Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3 ^[5]

End point description

Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participant’s response was recorded using a 100 mm VAS.

End point type

Secondary

End point timeframe

Month 3

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	129	132	131
Units: mm
least squares mean (standard error)	-21.59 ± 2.228	-19.88 ± 2.248	-7.14 ± 2.247

No statistical analyses for this end point

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3

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End point title

Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3 ^[6]

End point description

The blinded investigator or qualified assessor assessed how the participant’s overall arthritis appeared at the time of the visit. This was an evaluation based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS.

End point type

Secondary

End point timeframe

Month 3

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	128
Units: mm
least squares mean (standard error)	-27.25 ± 1.893	-28.95 ± 1.916	-15.88 ± 1.929

No statistical analyses for this end point

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3

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End point title

Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3 ^[7]

End point description

Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.

End point type

Secondary

End point timeframe

Month 3

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	130	132	131
Units: Joints
least squares mean (standard error)	-7.6 ± 0.59	-6.7 ± 0.6	-2.7 ± 0.6

No statistical analyses for this end point

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3

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End point title

Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3 ^[8]

End point description

Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.

End point type

Secondary

End point timeframe

Month 3

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Since participants received only Placebo up to 3 months in the ‘Placebo/Tofacitinib, 5 mg, twice daily’ and ‘Placebo/Tofacitinib, 10 mg, twice daily’ treatment groups, data up to and including 3 months are combined into one ‘Placebo’ subject analysis set.

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	130	132	131
Units: Joints
least squares mean (standard error)	-9.9 ± 0.97	-9.7 ± 0.98	-4.5 ± 0.98

No statistical analyses for this end point

Secondary: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6

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End point title

Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6

End point description

The PsARC covers 4 measures: Tender joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. n=number of responders, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Week 2, Months 1, 2, 3, 4, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	131	132	66	65	131
Units: Percentage of participants
number (not applicable)
Week 2 (n=43,45,NA,NA,23)	32.82	34.09	9999	9999	17.56
Month 1 (n=56,66,NA,NA,45)	42.75	50	9999	9999	34.35
Month 2 (n=67,72,NA,NA,43)	51.15	54.55	9999	9999	32.82
Month 3 (n=77,64,NA,NA,38)	58.78	48.48	9999	9999	29.01
Month 4 (n=74,75,34,38.NA)	56.49	56.82	51.52	58.46	9999
Month 6 (n=77,68,34,36,NA)	58.78	51.52	51.52	55.38	9999

No statistical analyses for this end point

Secondary: Change from Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) response: Months 1, 3, and 6

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End point title

Change from Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) response: Months 1, 3, and 6

End point description

The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine the PGA-PsO. Analysis: all participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO >0, and were evaluable. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	121	124	63	62	125
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=120,122,NA,NA,125)	-0.5 ± 0.07	-0.8 ± 0.07	9999 ± 9999	9999 ± 9999	-0.2 ± 0.07
Month 3 (n=112,116,NA,NA,112)	-0.7 ± 0.08	-1.1 ± 0.08	9999 ± 9999	9999 ± 9999	-0.4 ± 0.08
Month 6 (n=116,108,55,51,NA)	-0.9 ± 0.08	-1.1 ± 0.09	-1 ± 0.12	-1 ± 0.13	9999 ± 9999

No statistical analyses for this end point

Secondary: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6

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End point title

Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6

End point description

PASI determines psoriasis severity based on lesion severity & % of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration & scaling; each evaluated separately for head & neck, upper limbs, trunk & lower limbs then rated for each body area on a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is given a numerical score. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the 4 body areas is the PASI. PASI75 defined as 75% reduction from baseline in PASI. Analysis: all participants with PASI >0 and BSA ≥3% at baseline. n=number of responders, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	80	81	42	44	86
Units: Percentage of participants
number (not applicable)
Month 1 (n=12,15,NA,NA,5)	15	18.52	9999	9999	5.81
Month 3 (n=17,35,NA,NA,12)	21.25	43.21	9999	9999	13.95
Month 6 (n=27,37,11,14,NA)	33.75	45.68	26.19	31.82	9999

No statistical analyses for this end point

Secondary: Change from Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6

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End point title

Change from Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6

End point description

Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. Analysis population: all participants who were randomized, received at least 1 dose of study drug with baseline DSS >0, and were evaluable. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	65	64	29	33	62
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=65,64,NA,NA,62)	-2.8 ± 0.63	-4 ± 0.65	9999 ± 9999	9999 ± 9999	-1.1 ± 0.64
Month 3 (n=64,58,NA,NA,55)	-5.2 ± 0.73	-5.4 ± 0.78	9999 ± 9999	9999 ± 9999	-1.9 ± 0.78
Month 6 (n=61,55,25,26,NA)	-6 ± 0.84	-6 ± 0.9	-5.4 ± 1.33	-5.2 ± 1.26	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6

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End point title

Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6

End point description

The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. Analysis population: All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Index >0, and were evaluable. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	95	105	47	51	98
Units: Units of scale
least squares mean (standard error)
Month 1 (n=94,104,NA,NA,98)	-1.9 ± 0.31	-1.9 ± 0.3	9999 ± 9999	9999 ± 9999	-1 ± 0.3
Month 3 (n=92,96,NA,NA,87)	-2.5 ± 0.34	-2.8 ± 0.33	9999 ± 9999	9999 ± 9999	-1.3 ± 0.34
Month 6 (n=91,93,40,43,NA)	-2.6 ± 0.36	-3.1 ± 0.35	-2.6 ± 0.53	-2.4 ± 0.51	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6

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End point title

Change from Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6

End point description

Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for a total score of 0-6. Higher score indicates greater severity of enthesitis. Analysis population: all participants who were randomized, received at least 1 dose of study drug with baseline LEI >0, and were evaluable. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, and 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	82	96	45	46	91
Units: Units of scale
least squares mean (standard error)
Month 1 (n=82,95,NA,NA,91)	-1 ± 0.19	-0.8 ± 0.18	9999 ± 9999	9999 ± 9999	-0.5 ± 0.18
Month 3 (n=79,86,NA,NA,82)	-1.3 ± 0.19	-1.3 ± 0.18	9999 ± 9999	9999 ± 9999	-0.5 ± 0.19
Month 6 (n=77,84,38,41,NA)	-1.5 ± 0.19	-1.6 ± 0.18	-1.4 ± 0.26	-1.3 ± 0.26	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical Component Summary Score: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical Component Summary Score: Months 1, 3, 6

End point description

The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary score and the mental component summary score. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	124	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=124,127,NA,NA,129)	4.65 ± 0.543	3.98 ± 0.542	9999 ± 9999	9999 ± 9999	1.7 ± 0.534
Month 3 (n=121,120,NA,NA,117)	5.18 ± 0.684	5.34 ± 0.687	9999 ± 9999	9999 ± 9999	1.77 ± 0.689
Month 6 (n=118,110,56,56,NA)	5.71 ± 0.751	5 ± 0.768	6.45 ± 1.076	6.98 ± 1.074	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Component Summary Score: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Component Summary Score: Months 1, 3, 6

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	124	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=124,127,NA,NA,129)	4.09 ± 0.74	4.19 ± 0.738	9999 ± 9999	9999 ± 9999	2.33 ± 0.725
Month 3 (n=121,120,NA,NA,117)	4.94 ± 0.875	4.28 ± 0.879	9999 ± 9999	9999 ± 9999	2.97 ± 0.88
Month 6 (n=118,110,56,56,NA)	5.36 ± 0.878	5.37 ± 0.902	5.37 ± 1.265	6.47 ± 1.259	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical functioning Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical functioning Domain: Months 1, 3, 6

End point description

The 10 items of the physical functioning scale represent levels and kinds of limitations between the extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture both the presence and extent of physical limitations using a 3-level response continuum. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,129,NA,NA,129)	3.97 ± 0.583	3.1 ± 0.587	9999 ± 9999	9999 ± 9999	1.55 ± 0.58
Month 3 (n=124,120,NA,NA,117)	5 ± 0.721	4.08 ± 0.732	9999 ± 9999	9999 ± 9999	1.69 ± 0.734
Month 6 (n=121,112,56,56,NA)	5.39 ± 0.795	3.88 ± 0.818	5.89 ± 1.153	5.6 ± 1.149	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-physical Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-physical Domain: Months 1, 3, 6

End point description

The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role-physical scale are answered on a 5-point scale. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	126	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=126,128,NA,NA,129)	4.22 ± 0.63	3.55 ± 0.633	9999 ± 9999	9999 ± 9999	2.24 ± 0.623
Month 3 (n=122,120,NA,NA,117)	4.99 ± 0.805	5.44 ± 0.814	9999 ± 9999	9999 ± 9999	2.85 ± 0.814
Month 6 (n=120,112,56,56,NA)	5.58 ± 0.857	5.24 ± 0.881	7.01 ± 1.241	7.21 ± 1.239	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Bodily Pain Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Bodily Pain Domain: Months 1, 3, 6

End point description

The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	127	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=127,128,NA,NA,129)	6.86 ± 0.634	6.39 ± 0.638	9999 ± 9999	9999 ± 9999	2.31 ± 0.633
Month 3 (n=124,120,NA,NA,117)	7 ± 0.786	7.59 ± 0.799	9999 ± 9999	9999 ± 9999	2.1 ± 0.804
Month 6 (n=121,112,56,56,NA)	7.6 ± 0.848	7.69 ± 0.876	8.15 ± 1.234	10.48 ± 1.236	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): General Health Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): General Health Domain: Months 1, 3, 6

End point description

The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent’s view and expectations of his or her health. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,128,NA,NA,129)	3.24 ± 0.529	3.74 ± 0.535	9999 ± 9999	9999 ± 9999	2.29 ± 0.527
Month 3 (n=124,120,NA,NA,117)	3.67 ± 0.639	3.92 ± 0.651	9999 ± 9999	9999 ± 9999	2.45 ± 0.651
Month 6 (n=121,111,56,56,NA)	3.88 ± 0.695	4.46 ± 0.719	6 ± 1.01	5.34 ± 1.01	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Vitality Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Vitality Domain: Months 1, 3, 6

End point description

This 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,128,NA,NA,129)	4.52 ± 0.678	4.3 ± 0.684	9999 ± 9999	9999 ± 9999	1.73 ± 0.674
Month 3 (n=124,120,NA,NA,117)	4.95 ± 0.828	4.75 ± 0.842	9999 ± 9999	9999 ± 9999	2.41 ± 0.843
Month 6 (n=122,111,56,56,NA)	5.94 ± 0.859	5.15 ± 0.894	5.75 ± 1.256	7.06 ± 1.256	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Social Functioning Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Social Functioning Domain: Months 1, 3, 6

End point description

This 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,129,NA,NA,129)	4.93 ± 0.748	4.92 ± 0.754	9999 ± 9999	9999 ± 9999	2.33 ± 0.744
Month 3 (n=124,120,NA,NA,117)	6.25 ± 0.844	5.46 ± 0.861	9999 ± 9999	9999 ± 9999	2.89 ± 0.861
Month 6 (n=122,112,56,56,NA)	5.92 ± 0.896	5.58 ± 0.93	5.96 ± 1.309	7.9 ± 1.305	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-emotional Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-emotional Domain: Months 1, 3, 6

End point description

The 3-item role-emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	125	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=125,128,NA,NA,129)	4.44 ± 0.894	3.64 ± 0.892	9999 ± 9999	9999 ± 9999	3.25 ± 0.878
Month 3 (n=121,120,NA,NA,117)	5.44 ± 0.998	4.84 ± 1.003	9999 ± 9999	9999 ± 9999	3.85 ± 1.002
Month 6 (n=119,111,56,56,NA)	6.17 ± 1.01	5.69 ± 1.04	7.05 ± 1.461	8 ± 1.455	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Health Domain: Months 1, 3, 6

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End point title

Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Health Domain: Months 1, 3, 6

End point description

The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,128,NA,NA,129)	3.8 ± 0.737	4.41 ± 0.743	9999 ± 9999	9999 ± 9999	1.73 ± 0.732
Month 3 (n=124,120,NA,NA,117)	4.36 ± 0.852	4.11 ± 0.867	9999 ± 9999	9999 ± 9999	2.11 ± 0.868
Month 6 (n=122,112,56,56,NA)	4.38 ± 0.854	4.98 ± 0.884	5.06 ± 1.245	5.67 ± 1.241	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6

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End point title

Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6

End point description

The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,128,NA,NA,129)	-0.15 ± 0.035	-0.1 ± 0.036	9999 ± 9999	9999 ± 9999	-0.08 ± 0.035
Month 3 (n=124,120,NA,NA,117)	-0.17 ± 0.038	-0.15 ± 0.039	9999 ± 9999	9999 ± 9999	-0.05 ± 0.039
Month 6 (n=122,112,56,55,NA)	-0.15 ± 0.04	-0.15 ± 0.042	-0.23 ± 0.059	-0.32 ± 0.059	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6

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End point title

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	127	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=127,128,NA,NA,129)	-0.11 ± 0.039	-0.14 ± 0.039	9999 ± 9999	9999 ± 9999	-0.03 ± 0.038
Month 3 (n=122,120,NA,NA,117)	-0.15 ± 0.039	-0.15 ± 0.04	9999 ± 9999	9999 ± 9999	-0.04 ± 0.039
Month 6 (n=120,112,56,55,NA)	-0.19 ± 0.04	-0.15 ± 0.042	-0.19 ± 0.058	-0.17 ± 0.059	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6

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End point title

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,128,NA,NA,129)	-0.22 ± 0.039	-0.19 ± 0.039	9999 ± 9999	9999 ± 9999	-0.17 ± 0.039
Month 3 (n=124,120,NA,NA,117)	-0.23 ± 0.042	-0.22 ± 0.042	9999 ± 9999	9999 ± 9999	-0.15 ± 0.043
Month 6 (n=122,112,56,55,NA)	-0.3 ± 0.047	-0.25 ± 0.048	-0.39 ± 0.068	-0.34 ± 0.068	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6

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End point title

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,128,NA,NA,129)	-0.26 ± 0.038	-0.25 ± 0.039	9999 ± 9999	9999 ± 9999	-0.11 ± 0.038
Month 3 (n=124,120,NA,NA,117)	-0.32 ± 0.043	-0.29 ± 0.044	9999 ± 9999	9999 ± 9999	-0.12 ± 0.044
Month 6 (n=121,112,56,55,NA)	-0.34 ± 0.045	-0.31 ± 0.047	-0.42 ± 0.066	-0.34 ± 0.067	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6

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End point title

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,128,NA,NA,129)	-0.13 ± 0.043	-0.21 ± 0.043	9999 ± 9999	9999 ± 9999	-0.1 ± 0.042
Month 3 (n=124,120,NA,NA,117)	-0.19 ± 0.044	-0.2 ± 0.045	9999 ± 9999	9999 ± 9999	-0.12 ± 0.045
Month 6 (n=122,112,56,55,NA)	-0.16 ± 0.046	-0.2 ± 0.048	-0.17 ± 0.068	-0.31 ± 0.068	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6

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End point title

Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: mm
least squares mean (standard error)
Month 1 (n=127,128,NA,NA,128)	9.76 ± 1.565	9.58 ± 1.574	9999 ± 9999	9999 ± 9999	3.59 ± 1.557
Month 3 (n=124,119,NA,NA,117)	8.62 ± 1.853	12.33 ± 1.896	9999 ± 9999	9999 ± 9999	2.64 ± 1.896
Month 6 (n=122,112,56,55,NA)	12.14 ± 1.87	12.63 ± 1.945	15.68 ± 2.736	15.32 ± 2.748	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6

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End point title

Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6

End point description

FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,129,NA,NA,129)	6 ± 0.66	4.4 ± 0.67	9999 ± 9999	9999 ± 9999	2.2 ± 0.66
Month 3 (n=124,120,NA,NA,117)	7 ± 0.81	5.8 ± 0.82	9999 ± 9999	9999 ± 9999	3 ± 0.82
Month 6 (n=122,113,56,56,NA)	7.1 ± 0.87	6.2 ± 0.9	7.6 ± 1.28	8.5 ± 1.28	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6

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End point title

Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,129,NA,NA,129)	2.7 ± 0.31	2.3 ± 0.31	9999 ± 9999	9999 ± 9999	1 ± 0.3
Month 3 (n=124,120,NA,NA,117)	3.1 ± 0.38	2.6 ± 0.39	9999 ± 9999	9999 ± 9999	1.5 ± 0.39
Month 6 (n=122,113,56,56,NA)	2.9 ± 0.4	2.8 ± 0.41	3.2 ± 0.58	4.1 ± 0.58	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6

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End point title

Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6

End point description

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	128	130	64	65	129
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=128,129,NA,NA,129)	3.3 ± 0.4	2.1 ± 0.41	9999 ± 9999	9999 ± 9999	1.2 ± 0.4
Month 3 (n=124,120,NA,NA,117)	3.9 ± 0.48	3.2 ± 0.49	9999 ± 9999	9999 ± 9999	1.6 ± 0.49
Month 6 (n=122,113,56,56,NA)	4.2 ± 0.52	3.5 ± 0.54	4.3 ± 0.76	4.5 ± 0.76	9999 ± 9999

No statistical analyses for this end point

Secondary: Change from Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6

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End point title

Change from Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6

End point description

BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participants answered 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averaged the individual assessments for a final score ranging 0-10. Analysis population: all participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score >0 cm, and were evaluable. n=number of participants evaluable, NA=not applicable, 9999=results not reported for this group.

End point type

Secondary

End point timeframe

Months 1, 3, 6

End point values	Tofacitinib, 5 mg twice daily	Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	26	25	10	12	22
Units: cm
least squares mean (standard error)
Month 1 (n=26,25,NA,NA,22)	-2.04 ± 0.4	-1.26 ± 0.412	9999 ± 9999	9999 ± 9999	-0.34 ± 0.415
Month 3 (n=26,22,NA,NA,19)	-2.26 ± 0.465	-1.92 ± 0.49	9999 ± 9999	9999 ± 9999	-1 ± 0.506
Month 6 (n=25,22,8,10,NA)	-2.02 ± 0.463	-1.56 ± 0.489	-2.26 ± 0.756	-3.05 ± 0.701	9999 ± 9999

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events (AEs) were assessed from first administration of study treatment through last visit. Serious AEs (SAEs) were assessed from informed consent through and including 28 calendar days after last administration of investigational product.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Tofacitinib, 5 mg twice daily

Reporting group description

Participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.

Reporting group title

Placebo/Tofacitinib, 5 mg, twice daily

Reporting group description

Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received one 5 mg tofacitinib tablet twice daily and one placebo tablet twice daily.

Reporting group title

Placebo/Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received two placebo tablets twice daily up to 3 months. At the end of this period, participants received two 5 mg tofacitinib tablets twice daily.

Reporting group title

Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received two 5 mg tofacitinib tablets twice daily.

Serious adverse events	Tofacitinib, 5 mg twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Tofacitinib, 10 mg, twice daily
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 131 (3.82%)	2 / 66 (3.03%)	1 / 65 (1.54%)	8 / 132 (6.06%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertensive crisis
subjects affected / exposed	0 / 131 (0.00%)	1 / 66 (1.52%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypotension
subjects affected / exposed	1 / 131 (0.76%)	0 / 66 (0.00%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 131 (0.76%)	0 / 66 (0.00%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	1 / 131 (0.76%)	0 / 66 (0.00%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	0 / 131 (0.00%)	1 / 66 (1.52%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	1 / 65 (1.54%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Inguinal hernia
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 131 (0.00%)	1 / 66 (1.52%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Hyperthyroidism
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Oral candidiasis
subjects affected / exposed	1 / 131 (0.76%)	0 / 66 (0.00%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Parotitis
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 131 (0.76%)	0 / 66 (0.00%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 131 (0.00%)	0 / 66 (0.00%)	0 / 65 (0.00%)	1 / 132 (0.76%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 131 (0.76%)	0 / 66 (0.00%)	0 / 65 (0.00%)	0 / 132 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Tofacitinib, 5 mg twice daily	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Tofacitinib, 10 mg, twice daily
Total subjects affected by non serious adverse events
subjects affected / exposed	49 / 131 (37.40%)	19 / 66 (28.79%)	19 / 65 (29.23%)	48 / 132 (36.36%)
Vascular disorders
Hypertension
subjects affected / exposed	8 / 131 (6.11%)	2 / 66 (3.03%)	2 / 65 (3.08%)	5 / 132 (3.79%)
occurrences all number	8	2	2	5
Nervous system disorders
Dizziness
subjects affected / exposed	7 / 131 (5.34%)	0 / 66 (0.00%)	1 / 65 (1.54%)	1 / 132 (0.76%)
occurrences all number	8	0	1	1
Headache
subjects affected / exposed	10 / 131 (7.63%)	3 / 66 (4.55%)	4 / 65 (6.15%)	12 / 132 (9.09%)
occurrences all number	11	3	5	13
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	10 / 131 (7.63%)	2 / 66 (3.03%)	2 / 65 (3.08%)	8 / 132 (6.06%)
occurrences all number	10	2	2	8
Nausea
subjects affected / exposed	5 / 131 (3.82%)	5 / 66 (7.58%)	4 / 65 (6.15%)	7 / 132 (5.30%)
occurrences all number	5	5	4	7
Infections and infestations
Bronchitis
subjects affected / exposed	3 / 131 (2.29%)	1 / 66 (1.52%)	2 / 65 (3.08%)	7 / 132 (5.30%)
occurrences all number	3	1	2	7
Nasopharyngitis
subjects affected / exposed	14 / 131 (10.69%)	4 / 66 (6.06%)	1 / 65 (1.54%)	12 / 132 (9.09%)
occurrences all number	18	8	1	16
Sinusitis
subjects affected / exposed	3 / 131 (2.29%)	4 / 66 (6.06%)	2 / 65 (3.08%)	5 / 132 (3.79%)
occurrences all number	3	4	2	5
Upper respiratory tract infection
subjects affected / exposed	12 / 131 (9.16%)	4 / 66 (6.06%)	7 / 65 (10.77%)	7 / 132 (5.30%)
occurrences all number	14	4	7	7

More information

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Were there any global substantial amendments to the protocol? Yes

14 May 2013

Included country specific requirement for participants in Taiwan to be ≥20 years of age for inclusion; increased absolute lymphocyte count to <1.0 × 10^9/L (<1000 mm^3) as exclusion criterion per regulatory feedback; replaced “target plaque lesion” with “site of enthesitis” for photography; added “Opportunistic Infections” as a criteria for participant discontinuation; updated Safety Event Review text; clarified need for radiologist or pulmonologist to read chest radiograph per local standard of care; in Czech Republic, included need for pulmonologist to review TB tests.

13 Dec 2013

Updated Introduction to reflect revised Investigator’s Brochure; included certolizumab minimum treatment duration and washout information since recent marketing approval for PsA; standardized text for washout period for other biologic agents per regulatory request; added ‘localized’ infection to exclusion criteria #15 and added new exclusion criterion (#28) for participants at risk of gastrointestinal tract perforation per regulatory request; clarified use of sexual abstinence as contraceptive method only when consistent with preferred and usual participant lifestyle, per regulatory request; modified rater qualifications for Physician’s Global Assessments to include healthcare professionals competent to perform the assessments; clarified expectation for pharmacokinetic sampling; included template language regarding protocol-specified serious adverse events.

03 Oct 2014

Clarified prohibited medications, per Brazil regulatory request; clarified rescue medication use prior to study visit per Brazil regulatory request; included updated Sponsor protocol template language.

01 Feb 2015

Additional contraceptive requirement was added for women of childbearing potential in Canada based upon Health Canada Guidance document; clarification of washout of prohibited medications was added, per Brazil regulatory request; language was updated for Adjudicated Safety Events and Safety Event Review Committees.

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

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Clinical trials

Clinical Trial Results: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of Tofacitinib (CP-690,550) in Subjects with Active Psoriatic Arthritis and an Inadequate Response to at Least One TNF Inhibitor

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Month 3

Primary: Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Month 3

Primary: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3

Primary: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria greater than or equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6

Secondary: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6

Secondary: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3

Secondary: Change from Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3

Secondary: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6

Secondary: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6

Secondary: Change from Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) response: Months 1, 3, and 6

Secondary: Change from Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) response: Months 1, 3, and 6

Secondary: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6

Secondary: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6

Secondary: Change from Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6

Secondary: Change from Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6

Secondary: Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6

Secondary: Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6

Secondary: Change from Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6

Secondary: Change from Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical Component Summary Score: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical Component Summary Score: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Component Summary Score: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Component Summary Score: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical functioning Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Physical functioning Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-physical Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-physical Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Bodily Pain Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Bodily Pain Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): General Health Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): General Health Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Vitality Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Vitality Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Social Functioning Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Social Functioning Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-emotional Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Role-emotional Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Health Domain: Months 1, 3, 6

Secondary: Change from Baseline in the Short-Form-36 Health Survey Version 2, Acute (SF-36v2 acute): Mental Health Domain: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6

Secondary: Change from Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6

Secondary: Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6

Secondary: Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6

Clinical Trial Results:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of Tofacitinib (CP-690,550) in Subjects with Active Psoriatic Arthritis and an Inadequate Response to at Least One TNF Inhibitor