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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) or Adalimumab in Subjects With Active Psoriatic Arthritis

Summary
EudraCT number	2011-003668-55
Trial protocol	BE CZ ES SK HU DE PL BG
Global end of trial date	18 Dec 2015

Results information
Results version number	v1(current)
This version publication date	22 Dec 2016
First version publication date	22 Dec 2016
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

A3921091

ISRCTN number

US NCT number

NCT01877668

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., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, 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

18 Dec 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Dec 2015

Global end of trial reached?

Yes

Global end of trial date

18 Dec 2015

Was the trial ended prematurely?

Main objective of the trial

The main objectives of this trail were to compare the efficacy of tofacitinib at doses of 5 mg twice daily (BID) and 10 mg BID versus placebo for the treatment of rheumatological signs and symptoms of psoriatic arthritis (PsA), to compare physical function status, and to compare the safety and tolerability of 2 doses (5 mg BID and 10 mg BID) of tofacitinib versus placebo in participants with active PsA who have had an inadequate response to conventional synthetic disease modifying anti rheumatic drugs.

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

Eligible participants remained on a stable dose of 1 conventional synthetic disease-modifying anti-rheumatic drug treatment (ie, methotrexate, sulfasalazine, leflunomide, or others as approved by the Pfizer study clinician) as background therapy.

Evidence for comparator

Adalimumab was included in a reference arm as an active control. An adalimumab dose of 40 mg subcutaneously administered every 2 weeks is the approved dose for rheumatoid arthritis and psoriasis and was the dose used in this study.

Actual start date of recruitment

20 Jan 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 12

Country: Number of subjects enrolled

Belgium: 3

Country: Number of subjects enrolled

Bulgaria: 28

Country: Number of subjects enrolled

Canada: 5

Country: Number of subjects enrolled

Czech Republic: 18

Country: Number of subjects enrolled

France: 1

Country: Number of subjects enrolled

Germany: 11

Country: Number of subjects enrolled

Hungary: 31

Country: Number of subjects enrolled

Mexico: 15

Country: Number of subjects enrolled

Poland: 160

Country: Number of subjects enrolled

Russian Federation: 39

Country: Number of subjects enrolled

Slovakia: 12

Country: Number of subjects enrolled

Spain: 19

Country: Number of subjects enrolled

Taiwan: 6

Country: Number of subjects enrolled

United Kingdom: 15

Country: Number of subjects enrolled

United States: 47

Worldwide total number of subjects

422

EEA total number of subjects

298

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)

384

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Of 611 participants screened for entry into the study, 422 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

Investigator, Subject

Are arms mutually exclusive

Yes

Tofacitinib, 5 mg, twice daily

Arm description

Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.

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 1 matching placebo tablet) and subcutaneous placebo every 2 weeks during the placebo controlled period (up to Month 3) and the active extension period (from Month 3 to Month 12).

Tofacitinib, 10 mg, twice daily

Arm description

Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.

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 10 mg administered twice daily and subcutaneous placebo every 2 weeks during the placebo controlled period (up to Month 3) and the active extension period (from Month 3 to Month 12).

Adalimumab, 40 mg, every 2 weeks

Arm description

Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.

Arm type

Active comparator

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo tablets administered twice daily and subcutaneous adalimumab 40 mg every 2 weeks during the placebo controlled period (up to Month 3) and the active extension period (from Month 3 to Month 12).

Placebo/Tofacitinib, 5 mg, twice daily

Arm description

Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo every 2 weeks.

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

Placebo tablets administered twice daily and subcutaneous placebo every 2 weeks during the placebo controlled period (up to Month 3) followed by tofacitinib 5 mg administered twice daily (with 1 matching placebo tablet) during the active extension period (from Month 3 to Month 12).

Placebo/Tofacitinib, 10 mg, twice daily

Arm description

Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months. At the end of this period, participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.

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

Placebo tablets administered twice daily and subcutaneous placebo every 2 weeks during the placebo controlled period (up to Month 3) followed by tofacitinib 10 mg administered twice daily during the active extension period (from Month 3 to Month 12).

Number of subjects in period 1	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily
Started	107	104	106	52	53
Completed	96	96	94	44	43
Not completed	11	8	12	8	10
Adverse event, serious fatal	-	-	-	1	-
No longer met study criteria	1	-	1	-	-
Consent withdrawn by subject	2	-	3	2	2
Not specified	1	1	1	1	3
Adverse event unrelated to study drug	4	1	2	-	1
Lost to follow-up	-	2	1	-	-
Adverse event related to study drug	2	2	2	2	1
Protocol deviation	1	1	-	-	3
Insufficient clinical response	-	1	2	2	-

Baseline characteristics

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Reporting group title

Tofacitinib, 5 mg, twice daily

Reporting group description

Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.

Reporting group title

Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.

Reporting group title

Adalimumab, 40 mg, every 2 weeks

Reporting group description

Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.

Reporting group title

Placebo/Tofacitinib, 5 mg, twice daily

Reporting group description

Reporting group title

Placebo/Tofacitinib, 10 mg, twice daily

Reporting group description

Reporting group values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Total
Number of subjects	107	104	106	52	53	422
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0
Adults (18-64 years)	95	96	99	50	44	384
From 65-84 years	12	8	7	2	9	38
85 years and over	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	49.4 ( 12.6 )	46.9 ( 12.4 )	47.4 ( 11.3 )	46.1 ( 10.4 )	49.3 ( 13.8 )	-
Gender, Male/Female
Units: Subjects
Female	57	62	50	28	28	225
Male	50	42	56	24	25	197

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.

Subject analysis sets values	Placebo
Number of subjects	105
Age categorical
Units: Subjects
In utero	0
Preterm newborn infants (gestational age < 37 wks)	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	94
From 65-84 years	11
85 years and over	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	47.7 ( 12.3 )
Gender, Male/Female
Units: Subjects
Female	56
Male	49

End points

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Reporting group title

Tofacitinib, 5 mg, twice daily

Reporting group description

Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.

Reporting group title

Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.

Reporting group title

Adalimumab, 40 mg, every 2 weeks

Reporting group description

Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.

Reporting group title

Placebo/Tofacitinib, 5 mg, twice daily

Reporting group description

Reporting group title

Placebo/Tofacitinib, 10 mg, twice daily

Reporting group description

Subject analysis set title

Placebo

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.

Primary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3

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End point title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥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

At end of 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	107	104	106	105
Units: Percentage or participants
number (not applicable)	50.47	60.58	51.89	33.33

Analysis of ACR20

Comparison groups

Tofacitinib, 5 mg, twice daily v Placebo

Number of subjects included in analysis

212

Analysis specification

Pre-specified

Analysis type

^[2]

P-value

= 0.0102

Method

Large sample approximation

Parameter type

Risk difference (RD)

Point estimate

17.13

Confidence interval

level

95%

sides

2-sided

lower limit

4.06

upper limit

30.21

Variability estimate

Standard error of the mean

Dispersion value

6.67

Notes
[2] - Missing response (MR) = non-response (NR)

Analysis of ACR20

Comparison groups

Tofacitinib, 10 mg, twice daily v Placebo

Number of subjects included in analysis

209

Analysis specification

Pre-specified

Analysis type

^[3]

P-value

< 0.0001

Method

Large sample approximation

Parameter type

Risk difference (RD)

Point estimate

27.24

Confidence interval

level

95%

sides

2-sided

lower limit

14.22

upper limit

40.26

Variability estimate

Standard error of the mean

Dispersion value

6.64

Notes
[3] - MR = NR

Analysis of ACR20

Comparison groups

Adalimumab, 40 mg, every 2 weeks v Placebo

Number of subjects included in analysis

211

Analysis specification

Pre-specified

Analysis type

^[4]

P-value

= 0.0055

Method

Large sample approximation

Parameter type

Risk difference (RD)

Point estimate

18.55

Confidence interval

level

95%

sides

2-sided

lower limit

5.45

upper limit

31.66

Variability estimate

Standard error of the mean

Dispersion value

6.69

Notes
[4] - MR = NR

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 ^[5]

End point description

The HAQ-DI assesses the difficulty a participant 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

From Baseline to 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	107	104	106	104
Units: Units on a scale
least squares mean (standard error)	-0.3499 ( 0.04665 )	-0.3998 ( 0.04716 )	-0.3808 ( 0.04767 )	-0.1802 ( 0.05031 )

Analysis of HAQ-DI

Comparison groups

Tofacitinib, 5 mg, twice daily v Placebo

Number of subjects included in analysis

211

Analysis specification

Pre-specified

Analysis type

^[6]

P-value

= 0.0062

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-0.1697

Confidence interval

level

95%

sides

2-sided

lower limit

-0.291

upper limit

-0.0483

Variability estimate

Standard error of the mean

Dispersion value

0.06173

Notes
[6] - No imputation.

Analysis of HAQ-DI

Comparison groups

Tofacitinib, 10 mg, twice daily v Placebo

Number of subjects included in analysis

208

Analysis specification

Pre-specified

Analysis type

^[7]

P-value

= 0.0004

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-0.2196

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3411

upper limit

-0.098

Variability estimate

Standard error of the mean

Dispersion value

0.06184

Notes
[7] - No imputation.

Analysis of HAQ-DI

Comparison groups

Adalimumab, 40 mg, every 2 weeks v Placebo

Number of subjects included in analysis

210

Analysis specification

Pre-specified

Analysis type

^[8]

P-value

= 0.0012

Method

Mixed models analysis

Parameter type

Mean difference (net)

Point estimate

-0.2005

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3213

upper limit

-0.0797

Variability estimate

Standard error of the mean

Dispersion value

0.06145

Notes
[8] - No imputation.

Secondary: Change From Baseline in the Van der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis at Month 12

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End point title

Change From Baseline in the Van der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis at Month 12

End point description

Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.

End point type

Secondary

End point timeframe

From Baseline to Month 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily
Number of subjects analysed	98	99	95	48	45
Units: Units on a scale
least squares mean (standard error)	0.01 ( 0.067 )	-0.01 ( 0.067 )	-0.07 ( 0.069 )	0 ( 0.094 )	0.09 ( 0.099 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12

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End point title

Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12

End point description

Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline.

End point type

Secondary

End point timeframe

At Month 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily
Number of subjects analysed	98	99	95	48	45
Units: Percentage of participants
number (not applicable)	4.08	5.05	2.11	4.17	8.89

No statistical analyses for this end point

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

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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, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of responders.

End point type

Secondary

End point timeframe

At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	107	104	106	52	53	105
Units: Percentage of participants
number (not applicable)
Week 2 (n=7, 7, 5, NA, NA, 1)	6.54	6.73	4.72	9999	9999	0.95
Month 1 (n=13, 20,12, NA, NA, 5)	12.15	19.23	11.32	9999	9999	4.76
Month 2 (n=23, 34, 24, NA, NA, 8)	21.5	32.69	22.64	9999	9999	7.62
Month 3 (n=30, 42, 35, NA, NA, 10)	28.04	40.38	33.02	9999	9999	9.52
Month 4 (n=38, 39, 34, 11, 17, NA)	35.51	37.5	32.08	21.15	32.08	9999
Month 6 (n=41, 48, 45, 17, 14, NA)	38.32	46.15	42.45	32.69	26.42	9999
Month 9 (n=45, 48, 49, 22, 23, NA)	42.06	46.15	46.23	42.31	43.4	9999
Month 12 (n=48, 50, 43, 21, 19, NA)	44.86	48.08	40.57	40.38	35.85	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, 6, 9, and 12

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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, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of responders.

End point type

Secondary

End point timeframe

At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	107	104	106	52	53	105
Units: Percentage of participants
number (not applicable)
Week 2 (n=0, 3, 1, NA, NA, 0)	0	2.88	0.94	9999	9999	0
Month 1 (n=5, 8, 4, NA, NA, 1)	4.67	7.69	3.77	9999	9999	0.95
Month 2 (n=10, 14, 13, NA, NA, 2)	9.35	13.46	12.26	9999	9999	1.9
Month 3 (n=18, 15, 20, NA, NA, 5)	16.82	14.42	18.87	9999	9999	4.76
Month 4 (n=24, 23, 21, 7, 8, NA)	22.43	22.12	19.81	13.46	15.09	9999
Month 6 (n=19, 33, 32, 10, 7, NA)	17.76	31.73	30.19	19.23	13.21	9999
Month 9 (n=21, 31, 30, 15, 12, NA)	19.63	29.81	28.3	28.85	22.64	9999
Month 12 (n=25, 32, 31, 12, 12, NA)	23.36	30.77	29.25	23.08	22.64	9999

No statistical analyses for this end point

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12

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End point title

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of responders.

End point type

Secondary

End point timeframe

At Week 2 and Months 1, 2, 4, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	107	104	106	52	53	105
Units: Percentage of participants
number (not applicable)
Week 2 (n=24, 33, 23, NA, NA, 6)	22.43	31.73	21.7	9999	9999	5.71
Month 1 (n=37, 50, 30, NA, NA, 11)	34.58	48.08	28.3	9999	9999	10.48
Month 2 (n=47, 57, 62, NA, NA, 28)	43.93	54.81	58.49	9999	9999	26.67
Month 4 (n=65, 60, 61, 27, 28, NA)	60.75	57.69	57.55	51.92	52.83	9999
Month 6 (n=63, 70, 68, 31, 30, NA)	58.88	67.31	64.15	59.62	56.6	9999
Month 9 (n=73, 76, 73, 35, 37, NA)	68.22	73.08	68.87	67.31	69.81	9999
Month 12 (n=73, 73, 64, 35, 31, NA)	68.22	70.19	60.38	67.31	58.49	9999

No statistical analyses for this end point

Secondary: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 2 and Months 1, 2, 4, 6, 9, and 12

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End point title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 2 and Months 1, 2, 4, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	107	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Week 2 (n=106, 102, 103, NA, NA, 102)	-0.1842 ( 0.04131 )	-0.2089 ( 0.04208 )	-0.2129 ( 0.04246 )	9999 ( 9999 )	9999 ( 9999 )	-0.0837 ( 0.04549 )
Month 1 (n=105, 103, 104, NA, NA, 103)	-0.2048 ( 0.04363 )	-0.2676 ( 0.04426 )	-0.3028 ( 0.04465 )	9999 ( 9999 )	9999 ( 9999 )	-0.1224 ( 0.04755 )
Month 2 (n=104, 104, 104, NA, NA, 102)	-0.2713 ( 0.04626 )	-0.4009 ( 0.04678 )	-0.3736 ( 0.04719 )	9999 ( 9999 )	9999 ( 9999 )	-0.1682 ( 0.04998 )
Month 4 (n=102, 100, 102, 50, 50, NA)	-0.4231 ( 0.04982 )	-0.4407 ( 0.05039 )	-0.3643 ( 0.05069 )	-0.285 ( 0.07075 )	-0.3302 ( 0.07128 )	9999 ( 9999 )
Month 6 (n=100, 100, 99, 48, 48, NA)	-0.4471 ( 0.05136 )	-0.4611 ( 0.05179 )	-0.4259 ( 0.05227 )	-0.3142 ( 0.07315 )	-0.3841 ( 0.07369 )	9999 ( 9999 )
Month 9 (n=99, 96, 96, 47, 45, NA)	-0.5119 ( 0.05038 )	-0.4847 ( 0.05096 )	-0.4304 ( 0.05143 )	-0.3843 ( 0.07185 )	-0.4839 ( 0.07276 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	-0.5391 ( 0.05324 )	-0.5104 ( 0.05365 )	-0.4478 ( 0.05426 )	-0.4104 ( 0.07646 )	-0.4569 ( 0.07704 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels at Month 3

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End point title

Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels at Month 3 ^[9]

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

From Baseline to end of Month 3

Notes
[9] - 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	101	103	99	101
Units: mg/L
least squares mean (standard error)	-5.5981 ( 0.80656 )	-6.6004 ( 0.80822 )	-7.8955 ( 0.82547 )	-0.8643 ( 0.86304 )

No statistical analyses for this end point

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain at Month 3

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End point title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain at Month 3 ^[10]

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

From Baseline to end of Month 3

Notes
[10] - 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	103	103	100	102
Units: mm
least squares mean (standard error)	-21.49 ( 2.325 )	-27.1 ( 2.342 )	-21.87 ( 2.389 )	-10.22 ( 2.499 )

No statistical analyses for this end point

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis at Month 3

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End point title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis at Month 3 ^[11]

End point description

Participant 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

From Baseline to end of Month 3

Notes
[11] - 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	103	103	101	102
Units: mm
least squares mean (standard error)	-20.08 ( 2.275 )	-25.5 ( 2.291 )	-21.47 ( 2.328 )	-11.4 ( 2.439 )

No statistical analyses for this end point

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis at Month 3

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End point title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis at Month 3 ^[12]

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

From Baseline to end of Month 3

Notes
[12] - 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	103	101	101	102
Units: mm
least squares mean (standard error)	-27.44 ( 1.998 )	-33.74 ( 2.021 )	-29.02 ( 2.043 )	-22.26 ( 2.121 )

No statistical analyses for this end point

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count at Month 3

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End point title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count at Month 3 ^[13]

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 assesed by a blinded assessor to determine the number of joints that were considered swelling.

End point type

Secondary

End point timeframe

From Baseline to end of Month 3

Notes
[13] - 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	103	103	101	102
Units: Joints
least squares mean (standard error)	-6.5 ( 0.58 )	-7.6 ( 0.58 )	-6.5 ( 0.59 )	-4.8 ( 0.62 )

No statistical analyses for this end point

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count at Month 3

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End point title

Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count at Month 3 ^[14]

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

From Baseline to end of Month 3

Notes
[14] - 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	Adalimumab, 40 mg, every 2 weeks	Placebo
Number of subjects analysed	103	103	101	102
Units: Joints
least squares mean (standard error)	-8.7 ( 1.04 )	-11 ( 1.05 )	-7.6 ( 1.07 )	-6.9 ( 1.1 )

No statistical analyses for this end point

Secondary: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

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End point title

Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of responders.

End point type

Secondary

End point timeframe

At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	107	104	106	52	53	105
Units: Percentage of participants
number (not applicable)
Week 2 (n=34, 42, 23, NA, NA, 10)	31.78	40.38	21.7	9999	9999	9.52
Month 1 (n=45, 51, 43, NA, NA, 23)	42.06	49.04	40.57	9999	9999	21.9
Month 2 (n=54, 69, 62, NA, NA, 36)	50.47	66.35	58.49	9999	9999	34.29
Month 3 (n=55, 73, 65, NA, NA, 47)	51.4	70.19	61.32	9999	9999	44.76
Month 4 (n=68, 68, 71, 32, 30, NA)	63.55	65.38	66.98	61.54	56.6	9999
Month 6 (n=61, 75, 71, 35, 35, NA)	57.01	72.12	66.98	67.31	66.04	9999
Month 9 (n=75, 73, 71, 36, 37, NA)	70.09	70.19	66.98	69.23	69.81	9999
Month 12 (n=69, 76, 69, 39, 33, NA)	64.49	73.08	65.09	75	62.26	9999

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	101	98	102	50	50	100
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=100, 96, 100, NA, NA, 99)	-0.7 ( 0.07 )	-0.8 ( 0.08 )	-0.5 ( 0.08 )	9999 ( 9999 )	9999 ( 9999 )	-0.2 ( 0.08 )
Month 3 (n=98, 97, 98, NA, NA, 98)	-1 ( 0.08 )	-1.2 ( 0.08 )	-1 ( 0.09 )	9999 ( 9999 )	9999 ( 9999 )	-0.4 ( 0.09 )
Month 6 (n=96, 94, 96, 46, 46, NA)	-0.9 ( 0.09 )	-1.3 ( 0.09 )	-1.2 ( 0.09 )	-0.7 ( 0.12 )	-0.9 ( 0.13 )	9999 ( 9999 )
Month 9 (n=95, 91, 94, 45, 44, NA)	-1 ( 0.09 )	-1.5 ( 0.09 )	-1.2 ( 0.09 )	-0.7 ( 0.12 )	-1.3 ( 0.13 )	9999 ( 9999 )
Month 12 (n=91, 90, 92, 41, 43, NA)	-1.2 ( 0.09 )	-1.5 ( 0.09 )	-1.2 ( 0.09 )	-0.9 ( 0.13 )	-1.3 ( 0.13 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12

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End point title

Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12

End point description

PASI determines psoriasis severity based on lesion severity & percentage 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: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. 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 is defined as a 75% reduction from baseline in PASI. NA = not applicable, 9999 = results not reported for this group, n=number of responders.

End point type

Secondary

End point timeframe

At Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	82	70	77	42	40	82
Units: Percentage of participants
number (not applicable)
Month 1 (n=19, 19, 11, NA, NA, 4)	23.17	27.14	14.29	9999	9999	4.88
Month 3 (n=35, 31, 30, NA, NA, 12)	42.68	44.29	38.96	9999	9999	14.63
Month 6 (n=38, 42, 42, 12, 17, NA)	46.34	60	54.55	28.57	42.5	9999
Month 9 (n=36, 48, 45, 14, 20, NA)	43.9	68.57	58.44	33.33	50	9999
Month 12 (n=46, 47, 43, 15, 21, NA)	56.1	67.14	55.84	35.71	52.5	9999

No statistical analyses for this end point

Secondary: Change From Baseline in Dactylitis Severity Score (DSS) at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Dactylitis Severity Score (DSS) at Months 1, 3, 6, 9, and 12

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=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	60	60	58	29	28	57
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=58, 59, 56, NA, NA, 56)	-1.8 ( 0.91 )	-3.1 ( 0.87 )	-2.1 ( 0.93 )	9999 ( 9999 )	9999 ( 9999 )	0.6 ( 1.02 )
Month 3 (n=58, 60 , 56, NA, NA, 55)	-3.5 ( 0.95 )	-5.5 ( 0.91 )	-4 ( 0.97 )	9999 ( 9999 )	9999 ( 9999 )	-2 ( 1.06 )
Month 6 (n=58, 59, 55, 28, 25, NA)	-5.2 ( 1.01 )	-6.4 ( 0.99 )	-5.4 ( 1.03 )	-5.9 ( 1.45 )	-5.2 ( 1.5 )	9999 ( 9999 )
Month 9 (n=57, 59, 53, 27, 25, NA)	-7 ( 0.6 )	-7.2 ( 0.58 )	-6.5 ( 0.63 )	-5.3 ( 0.87 )	-7.9 ( 0.89 )	9999 ( 9999 )
Month 12 (n=54, 58, 52, 26, 24, NA)	-7.4 ( 0.65 )	-7.5 ( 0.62 )	-6.1 ( 0.67 )	-6.7 ( 0.93 )	-7.7 ( 0.96 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	80	81	82	38	41	79
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=79, 80, 80, NA, NA, 78)	-0.83 ( 0.317 )	-1.27 ( 0.321 )	-0.95 ( 0.336 )	9999 ( 9999 )	9999 ( 9999 )	-0.58 ( 0.355 )
Month 3 (n=77, 79, 79, NA, NA, 78)	-1.84 ( 0.363 )	-2.41 ( 0.364 )	-1.9 ( 0.375 )	9999 ( 9999 )	9999 ( 9999 )	-1.17 ( 0.393 )
Month 6 (n=76, 78, 76, 33, 39, NA)	-2.4 ( 0.34 )	-2.6 ( 0.34 )	-2.3 ( 0.35 )	-2.4 ( 0.5 )	-2.5 ( 0.48 )	9999 ( 9999 )
Month 9 (n=75, 75, 73, 34, 37, NA)	-2.9 ( 0.31 )	-2.6 ( 0.32 )	-3 ( 0.33 )	-2.8 ( 0.46 )	-3.2 ( 0.44 )	9999 ( 9999 )
Month 12 (n=72, 73, 72, 31, 37, NA)	-3.2 ( 0.33 )	-3.1 ( 0.33 )	-2.8 ( 0.35 )	-2.5 ( 0.49 )	-3.2 ( 0.46 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Leeds Enthesitis Index (LEI) at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Leeds Enthesitis Index (LEI) at Months 1, 3, 6, 9, and 12

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 an total score of 0–6. Higher score indicates a greater number of sites affected by enthesis. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	74	64	76	31	34	65
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=74, 63, 75, NA, NA, 65)	-0.41 ( 0.192 )	-0.57 ( 0.213 )	-0.42 ( 0.203 )	9999 ( 9999 )	9999 ( 9999 )	-0.26 ( 0.219 )
Month 3 (n=70, 63, 73, NA, NA, 63)	-0.82 ( 0.221 )	-1.46 ( 0.24 )	-1.1 ( 0.228 )	9999 ( 9999 )	9999 ( 9999 )	-0.43 ( 0.246 )
Month 6 (n=72, 61, 71, 27, 31, NA)	-1.3 ( 0.21 )	-1.2 ( 0.23 )	-1.3 ( 0.22 )	-1 ( 0.32 )	-1.3 ( 0.3 )	9999 ( 9999 )
Month 9 (n=70, 58, 68, 27, 29, NA)	-1.4 ( 0.2 )	-1.3 ( 0.23 )	-1.5 ( 0.21 )	-1.4 ( 0.31 )	-1.7 ( 0.3 )	9999 ( 9999 )
Month 12 (n=67, 56, 67, 24, 29, NA)	-1.7 ( 0.19 )	-1.6 ( 0.21 )	-1.6 ( 0.2 )	-1.4 ( 0.3 )	-1.9 ( 0.28 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	3.39 ( 0.638 )	4.66 ( 0.645 )	4 ( 0.655 )	9999 ( 9999 )	9999 ( 9999 )	1.54 ( 0.7 )
Month 3 (n=102, 103,100, NA, NA, 102)	5.51 ( 0.733 )	5.69 ( 0.735 )	6.23 ( 0.748 )	9999 ( 9999 )	9999 ( 9999 )	2.68 ( 0.785 )
Month 6 (n=100, 100, 98, 48, 48, NA)	6.72 ( 0.773 )	6.7 ( 0.777 )	6.26 ( 0.788 )	5.86 ( 1.101 )	6.07 ( 1.112 )	9999 ( 9999 )
Month 9 (n=99, 97, 95, 47, 46, NA)	7.52 ( 0.781 )	7.21 ( 0.787 )	6.91 ( 0.798 )	6.16 ( 1.115 )	7.15 ( 1.13 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 43, NA)	7.61 ( 0.806 )	7.67 ( 0.81 )	6.74 ( 0.822 )	5.82 ( 1.16 )	5.72 ( 1.177 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104,NA, NA, 103)	4.12 ( 0.841 )	3.63 ( 0.849 )	2.13 ( 0.871 )	9999 ( 9999 )	9999 ( 9999 )	3.19 ( 0.917 )
Month 3 (n=102, 103,100, NA, NA, 102)	4.35 ( 0.909 )	4.2 ( 0.909 )	3.13 ( 0.938 )	9999 ( 9999 )	9999 ( 9999 )	3.27 ( 0.976 )
Month 6 (n=100, 100, 98, 48, 48, NA)	5.7 ( 0.927 )	5.51 ( 0.93 )	4.58 ( 0.955 )	4.5 ( 1.319 )	3.62 ( 1.331 )	9999 ( 9999 )
Month 9 (n=99, 97, 95, 47, 46, NA)	5.07 ( 0.974 )	6.2 ( 0.982 )	3.68 ( 1.005 )	4.61 ( 1.391 )	6.03 ( 1.409 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 43, NA)	4.82 ( 1.012 )	6.26 ( 1.016 )	4.81 ( 1.039 )	4.51 ( 1.455 )	4.43 ( 1.474 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	2.43 ( 0.768 )	3.89 ( 0.776 )	2.81 ( 0.787 )	9999 ( 9999 )	9999 ( 9999 )	1.1 ( 0.84 )
Month 3 (n=102, 103,101, NA, NA, 102)	5.17 ( 0.846 )	5.23 ( 0.848 )	5.22 ( 0.862 )	9999 ( 9999 )	9999 ( 9999 )	2.06 ( 0.91 )
Month 6 (n=100, 100, 99, 48, 48, NA)	7.02 ( 0.897 )	6.15 ( 0.9 )	6.36 ( 0.912 )	5.22 ( 1.276 )	5.22 ( 1.291 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	7.43 ( 0.902 )	6.67 ( 0.909 )	7.01 ( 0.921 )	5.69 ( 1.285 )	6.25 ( 1.306 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	7.67 ( 0.899 )	7.11 ( 0.903 )	6.81 ( 0.917 )	6.49 ( 1.292 )	4.77 ( 1.308 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	4.05 ( 0.751 )	3.72 ( 0.759 )	4.09 ( 0.77 )	9999 ( 9999 )	9999 ( 9999 )	1.98 ( 0.82 )
Month 3 (n=102, 103, 100, NA, NA, 102)	4.45 ( 0.801 )	4.79 ( 0.803 )	5.21 ( 0.82 )	9999 ( 9999 )	9999 ( 9999 )	3.63 ( 0.862 )
Month 6 (n=100, 100, 99, 48, 48, NA)	6.02 ( 0.824 )	5.21 ( 0.828 )	5.48 ( 0.84 )	4.97 ( 1.172 )	5.03 ( 1.185 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	6.24 ( 0.853 )	6.56 ( 0.861 )	5.79 ( 0.872 )	4.68 ( 1.217 )	6.7 ( 1.234 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	6.21 ( 0.888 )	7.11 ( 0.892 )	6.37 ( 0.906 )	2.98 ( 1.279 )	5.03 ( 1.291 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	5.53 ( 0.777 )	7.16 ( 0.786 )	6.42 ( 0.802 )	9999 ( 9999 )	9999 ( 9999 )	3.44 ( 0.851 )
Month 3 (n=102, 103, 101, NA, NA, 102)	7.75 ( 0.838 )	8.05 ( 0.84 )	7.52 ( 0.859 )	9999 ( 9999 )	9999 ( 9999 )	3.77 ( 0.903 )
Month 6 (n=100, 100, 99, 48, 48, NA)	7.76 ( 0.985 )	10.65 ( 0.989 )	7.76 ( 1.004 )	8.55 ( 1.405 )	8.98 ( 1.425 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	9.03 ( 0.953 )	10.13 ( 0.96 )	8.59 ( 0.977 )	8.46 ( 1.362 )	10.81 ( 1.389 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 43, NA)	9.15 ( 0.961 )	11.38 ( 0.965 )	9.18 ( 0.984 )	8.59 ( 1.384 )	8.61 ( 1.413 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	3.29 ( 0.61 )	3.87 ( 0.616 )	1.96 ( 0.625 )	9999 ( 9999 )	9999 ( 9999 )	2.15 ( 0.666 )
Month 3 (n=102, 103,101, NA, NA, 102 )	4.09 ( 0.7 )	3.95 ( 0.701 )	4.73 ( 0.713 )	9999 ( 9999 )	9999 ( 9999 )	2.64 ( 0.748 )
Month 6 (n=100, 100, 99, 48, 48, NA)	5.96 ( 0.72 )	4.12 ( 0.722 )	4.81 ( 0.733 )	4.39 ( 1.022 )	3.92 ( 1.033 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	5.93 ( 0.773 )	5.18 ( 0.778 )	4.09 ( 0.788 )	4.72 ( 1.102 )	4.85 ( 1.117 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	5.7 ( 0.811 )	4.63 ( 0.815 )	4.21 ( 0.825 )	4.5 ( 1.164 )	4.12 ( 1.175 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	3.64 ( 0.802 )	4.59 ( 0.806 )	2.42 ( 0.826 )	9999 ( 9999 )	9999 ( 9999 )	2.16 ( 0.877 )
Month 3 (n=102, 103, 101, NA, NA, 102)	5.5 ( 0.889 )	5.9 ( 0.887 )	4.93 ( 0.909 )	9999 ( 9999 )	9999 ( 9999 )	3.05 ( 0.954 )
Month 6 (n=100, 100, 99, 48, 48, NA)	6.81 ( 0.969 )	7.41 ( 0.97 )	5.05 ( 0.989 )	5.34 ( 1.378 )	4.62 ( 1.394 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	6.09 ( 1.017 )	7.82 ( 1.023 )	5.27 ( 1.041 )	6.61 ( 1.451 )	6.39 ( 1.472 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	7.01 ( 1.022 )	7.02 ( 1.024 )	5.12 ( 1.043 )	5.62 ( 1.465 )	5.15 ( 1.481 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain at Months 1, 3, 6, 9, and 12

End point description

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

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	4.51 ( 0.827 )	4.46 ( 0.838 )	3.34 ( 0.852 )	9999 ( 9999 )	9999 ( 9999 )	2.96 ( 0.901 )
Month 3 (n=102, 103, 101, NA, NA, 102)	5.95 ( 0.897 )	5.22 ( 0.898 )	5.26 ( 0.918 )	9999 ( 9999 )	9999 ( 9999 )	3.63 ( 0.961 )
Month 6 (n=100, 100, 99, 48, 48, NA)	6.97 ( 0.955 )	7.08 ( 0.959 )	7.1 ( 0.975 )	5.44 ( 1.362 )	6.05 ( 1.373 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	7.66 ( 0.947 )	7.74 ( 0.957 )	5.69 ( 0.972 )	5.95 ( 1.355 )	8.93 ( 1.373 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	6.13 ( 0.989 )	8.42 ( 0.995 )	6.32 ( 1.012 )	6.19 ( 1.427 )	6.41 ( 1.445 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103,104, NA, NA, 103)	4.77 ( 0.96 )	3.87 ( 0.971 )	2.93 ( 0.991 )	9999 ( 9999 )	9999 ( 9999 )	4.52 ( 1.042 )
Month 3 (n=102, 103, 100, NA, NA, 102)	4.21 ( 1.01 )	4.82 ( 1.011 )	3.35 ( 1.04 )	9999 ( 9999 )	9999 ( 9999 )	3.68 ( 1.083 )
Month 6 (n=100, 100, 98, 48, 48, NA)	5.67 ( 1.024 )	4.68 ( 1.027 )	4.77 ( 1.051 )	6.34 ( 1.458 )	4.56 ( 1.473 )	9999 ( 9999 )
Month 9 (n=99, 97, 95, 47, 46, NA)	5.13 ( 1.021 )	6.13 ( 1.03 )	4.87 ( 1.052 )	5.89 ( 1.456 )	6.52 ( 1.478 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	5.15 ( 1.048 )	6.73 ( 1.053 )	6.03 ( 1.075 )	4.77 ( 1.509 )	4.94 ( 1.525 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain at Months 1, 3, 6, 9, and 12

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 behavioural/emotional control, and psychological well-being. All items are answered on a 5-point scale. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	3.32 ( 0.867 )	3.87 ( 0.874 )	2.79 ( 0.895 )	9999 ( 9999 )	9999 ( 9999 )	1.57 ( 0.952 )
Month 3 (n=102, 103, 101, NA, NA, 102)	4.45 ( 0.934 )	4.23 ( 0.932 )	3.95 ( 0.956 )	9999 ( 9999 )	9999 ( 9999 )	2.62 ( 1.009 )
Month 6 (n=100, 100, 99, 48, 48, NA)	6.11 ( 0.951 )	6.38 ( 0.953 )	5.35 ( 0.974 )	3.7 ( 1.354 )	3.41 ( 1.372 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	5.79 ( 1.022 )	6.43 ( 1.028 )	4.62 ( 1.048 )	3.57 ( 1.461 )	5.45 ( 1.483 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	5.86 ( 1.019 )	6.58 ( 1.022 )	5.86 ( 1.044 )	4.72 ( 1.467 )	4.48 ( 1.483 )	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 at Months 1, 3, 6, 9, and 12

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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 at Months 1, 3, 6, 9, and 12

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 visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	-0.07 ( 0.042 )	-0.19 ( 0.043 )	-0.15 ( 0.043 )	9999 ( 9999 )	9999 ( 9999 )	-0.1 ( 0.046 )
Month 3 (n=101, 103, 101, NA, NA, 102)	-0.28 ( 0.047 )	-0.27 ( 0.047 )	-0.29 ( 0.048 )	9999 ( 9999 )	9999 ( 9999 )	-0.11 ( 0.05 )
Month 6 (n=100, 100, 99, 48, 48, NA)	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.2 ( 0.05 )	-0.3 ( 0.07 )	-0.2 ( 0.07 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.07 )	-0.3 ( 0.07 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44,44, NA)	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.4 ( 0.07 )	-0.3 ( 0.07 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Self-care at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Self-care at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	103	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 102, 104, NA, NA, 103)	-0.11 ( 0.046 )	-0.16 ( 0.047 )	-0.16 ( 0.047 )	9999 ( 9999 )	9999 ( 9999 )	-0.09 ( 0.05 )
Month 3 (n=101, 102, 101, NA, NA, 102)	-0.19 ( 0.047 )	-0.11 ( 0.047 )	-0.18 ( 0.048 )	9999 ( 9999 )	9999 ( 9999 )	-0.12 ( 0.051 )
Month 6 (n=100, 99, 99, 48, 48, NA)	-0.2 ( 0.04 )	-0.3 ( 0.05 )	-0.2 ( 0.05 )	-0.2 ( 0.06 )	-0.3 ( 0.06 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	-0.2 ( 0.05 )	-0.2 ( 0.05 )	-0.3 ( 0.05 )	-0.2 ( 0.06 )	-0.3 ( 0.07 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	-0.2 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.07 )	-0.2 ( 0.07 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Usual Activities at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Usual Activities at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	103	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 102, 104, NA, NA, 103)	-0.17 ( 0.043 )	-0.19 ( 0.043 )	-0.21 ( 0.044 )	9999 ( 9999 )	9999 ( 9999 )	-0.06 ( 0.047 )
Month 3 (n=101, 102, 101, NA, NA, 102)	-0.24 ( 0.049 )	-0.29 ( 0.049 )	-0.29 ( 0.049 )	9999 ( 9999 )	9999 ( 9999 )	-0.17 ( 0.052 )
Month 6 (n=100, 99, 99, 48, 47, NA)	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.4 ( 0.05 )	-0.3 ( 0.07 )	-0.3 ( 0.07 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 ( 0.05 )	-0.4 ( 0.05 )	-0.4 ( 0.05 )	-0.3 ( 0.07 )	-0.4 ( 0.07 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	-0.3 ( 0.05 )	-0.4 ( 0.05 )	-0.4 ( 0.05 )	-0.3 ( 0.07 )	-0.3 ( 0.07 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Pain/Discomfort at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Pain/Discomfort at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	-0.14 ( 0.039 )	-0.25 ( 0.04 )	-0.19 ( 0.04 )	9999 ( 9999 )	9999 ( 9999 )	-0.08 ( 0.043 )
Month 3 (n=101, 103, 101, NA, NA, 102)	-0.25 ( 0.044 )	-0.27 ( 0.044 )	-0.28 ( 0.045 )	9999 ( 9999 )	9999 ( 9999 )	-0.08 ( 0.047 )
Month 6 (n=100, 100, 99, 48, 48, NA)	-0.3 ( 0.05 )	-0.4 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.07 )	-0.4 ( 0.07 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.4 ( 0.07 )	-0.4 ( 0.07 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	-0.3 ( 0.05 )	-0.4 ( 0.05 )	-0.3 ( 0.05 )	-0.2 ( 0.07 )	-0.3 ( 0.07 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Anxiety/Depression at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Anxiety/Depression at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	-0.25 ( 0.051 )	-0.22 ( 0.052 )	-0.27 ( 0.053 )	9999 ( 9999 )	9999 ( 9999 )	-0.21 ( 0.056 )
Month 3 (n=101, 103, 100, NA, NA, 102)	-0.25 ( 0.055 )	-0.17 ( 0.055 )	-0.32 ( 0.056 )	9999 ( 9999 )	9999 ( 9999 )	-0.21 ( 0.059 )
Month 6 (n=100, 100, 99, 48, 48, NA)	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.05 )	-0.3 ( 0.08 )	-0.2 ( 0.08 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	-0.3 ( 0.05 )	-0.4 ( 0.05 )	-0.4 ( 0.06 )	-0.2 ( 0.08 )	-0.3 ( 0.08 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	-0.3 ( 0.05 )	-0.4 ( 0.05 )	-0.4 ( 0.06 )	-0.2 ( 0.08 )	-0.3 ( 0.08 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Patient's Health State Today at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Patient's Health State Today at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: mm
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	10.75 ( 1.859 )	10.81 ( 1.88 )	10.27 ( 1.917 )	9999 ( 9999 )	9999 ( 9999 )	6.59 ( 2.027 )
Month 3 (n=101, 103, 101, NA, NA, 101)	14 ( 2.1 )	15.83 ( 2.092 )	13.1 ( 2.138 )	9999 ( 9999 )	9999 ( 9999 )	6.37 ( 2.242 )
Month 6 (n=100, 100, 99, 48, 48, NA)	19.5 ( 2.08 )	15.7 ( 2.09 )	15.5 ( 2.12 )	14.7 ( 2.97 )	16.6 ( 3 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	19.2 ( 2.21 )	15.9 ( 2.23 )	18.2 ( 2.26 )	12.8 ( 3.16 )	21.5 ( 3.21 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	20.7 ( 2.09 )	19.8 ( 2.09 )	16.5 ( 2.14 )	16 ( 3.02 )	19.8 ( 3.05 )	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 at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score at Months 1, 3, 6, 9, and 12

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. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	5.2 ( 0.77 )	4.4 ( 0.78 )	4.2 ( 0.79 )	9999 ( 9999 )	9999 ( 9999 )	2.7 ( 0.84 )
Month 3 (n=102, 102, 101, NA, NA, 102)	7 ( 0.85 )	6 ( 0.85 )	6 ( 0.87 )	9999 ( 9999 )	9999 ( 9999 )	3.3 ( 0.91 )
Month 6 (n=100, 100, 99,48, 48, NA)	7.9 ( 0.89 )	8 ( 0.89 )	6.5 ( 0.91 )	6.5 ( 1.26 )	7.2 ( 1.28 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	7.9 ( 0.92 )	7.4 ( 0.92 )	6.5 ( 0.94 )	5.5 ( 1.31 )	8.4 ( 1.33 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	8.5 ( 0.95 )	8.4 ( 0.95 )	6.9 ( 0.97 )	5.7 ( 1.36 )	7.6 ( 1.38 )	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 at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	2.4 ( 0.35 )	2.1 ( 0.35 )	2.1 ( 0.36 )	9999 ( 9999 )	9999 ( 9999 )	1.2 ( 0.38 )
Month 3 (n=102, 102, 101, NA, NA, 102)	3.3 ( 0.38 )	2.8 ( 0.38 )	2.9 ( 0.39 )	9999 ( 9999 )	9999 ( 9999 )	1.6 ( 0.41 )
Month 6 (n=100, 100, 99,48, 48, NA)	3.6 ( 0.4 )	3.3 ( 0.4 )	3.2 ( 0.41 )	3 ( 0.57 )	3.3 ( 0.58 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	3.6 ( 0.42 )	3.3 ( 0.42 )	3.3 ( 0.43 )	2.7 ( 0.59 )	3.9 ( 0.6 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	3.9 ( 0.44 )	3.7 ( 0.44 )	3.2 ( 0.45 )	2.7 ( 0.63 )	3.4 ( 0.63 )	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 at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score at Months 1, 3, 6, 9, and 12

End point description

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	106	104	106	52	52	104
Units: Units on a scale
least squares mean (standard error)
Month 1 (n=105, 103, 104, NA, NA, 103)	2.9 ( 0.47 )	2.3 ( 0.48 )	2.1 ( 0.49 )	9999 ( 9999 )	9999 ( 9999 )	1.5 ( 0.52 )
Month 3 (n=102, 102, 101, NA, NA, 102)	3.8 ( 0.52 )	3.2 ( 0.52 )	3.2 ( 0.53 )	9999 ( 9999 )	9999 ( 9999 )	1.8 ( 0.56 )
Month 6 (n=100, 100, 99,48, 48, NA)	4.3 ( 0.53 )	4.7 ( 0.53 )	3.4 ( 0.54 )	3.5 ( 0.75 )	4 ( 0.76 )	9999 ( 9999 )
Month 9 (n=99, 97, 96, 47, 46, NA)	4.3 ( 0.55 )	4.1 ( 0.55 )	3.3 ( 0.56 )	2.8 ( 0.78 )	4.6 ( 0.8 )	9999 ( 9999 )
Month 12 (n=96, 96, 94, 44, 44, NA)	4.6 ( 0.57 )	4.7 ( 0.57 )	3.7 ( 0.58 )	2.9 ( 0.82 )	4.3 ( 0.82 )	9999 ( 9999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) at Months 1, 3, 6, 9, and 12

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End point title

Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) at Months 1, 3, 6, 9, and 12

End point description

BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-10 (0=none and 10=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10. NA = not applicable, 9999 = results not reported for this group, n=number of participants evaluable.

End point type

Secondary

End point timeframe

From Baseline to Months 1, 3, 6, 9, and 12

End point values	Tofacitinib, 5 mg, twice daily	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Placebo/Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo
Number of subjects analysed	24	21	10	10	12	22
Units: cm
least squares mean (standard error)
Month 1 (n=24, 21, 10, NA, NA, 22)	-1.23 ( 0.537 )	-1.6 ( 0.508 )	-2.3 ( 0.673 )	9999 ( 9999 )	9999 ( 9999 )	-1.27 ( 0.581 )
Month 3 (n=24, 21, 10, NA, NA, 22)	-1.83 ( 0.579 )	-2.78 ( 0.559 )	-2.93 ( 0.753 )	9999 ( 9999 )	9999 ( 9999 )	-1.6 ( 0.624 )
Month 6 (n=23, 21, 10, 9, 11, NA)	-2.24 ( 0.58 )	-2.35 ( 0.56 )	-3.58 ( 0.758 )	-2.85 ( 0.778 )	-3.31 ( 0.744 )	9999 ( 9999 )
Month 9 (n=23, 20, 10, 9, 9, NA)	-2.06 ( 0.575 )	-2.71 ( 0.558 )	2.66 ( 0.747 )	-3 ( 0.77 )	-3.35 ( 0.761 )	9999 ( 9999 )
Month 12 (n=23, 19, 10, 9, 9, NA)	-2.5 ( 0.594 )	-3.3 ( 0.587 )	-2.42 ( 0.779 )	-2.31 ( 0.808 )	-2.67 ( 0.806 )	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

18.1

Reporting group title

Tofacitinib, 10 mg, twice daily

Reporting group description

Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.

Reporting group title

Adalimumab, 40 mg, every 2 weeks

Reporting group description

Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.

Reporting group title

Tofacitinib, 5 mg, twice daily

Reporting group description

Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.

Reporting group title

Placebo/Tofacitinib, 10 mg, twice daily

Reporting group description

Reporting group title

Placebo/Tofacitinib, 5 mg, twice daily

Reporting group description

Serious adverse events	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 104 (3.85%)	9 / 106 (8.49%)	8 / 107 (7.48%)	4 / 53 (7.55%)	3 / 52 (5.77%)
number of deaths (all causes)	0	0	0	0	1
number of deaths resulting from adverse events	0	0	0	0	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infected neoplasm
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of the vulva
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	1 / 53 (1.89%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Cystocele
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rectocele
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	1 / 53 (1.89%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Joint injury
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
Nervous system disorders
Migraine
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal hernia
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	1 / 53 (1.89%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	1 / 53 (1.89%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Calculus urinary
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephropathy
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	1 / 53 (1.89%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	1 / 107 (0.93%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	1 / 53 (1.89%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpes simplex
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 104 (0.00%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyoderma streptococcal
subjects affected / exposed	0 / 104 (0.00%)	1 / 106 (0.94%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 104 (0.96%)	0 / 106 (0.00%)	0 / 107 (0.00%)	0 / 53 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Tofacitinib, 10 mg, twice daily	Adalimumab, 40 mg, every 2 weeks	Tofacitinib, 5 mg, twice daily	Placebo/Tofacitinib, 10 mg, twice daily	Placebo/Tofacitinib, 5 mg, twice daily
Total subjects affected by non serious adverse events
subjects affected / exposed	43 / 104 (41.35%)	43 / 106 (40.57%)	31 / 107 (28.97%)	22 / 53 (41.51%)	15 / 52 (28.85%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	3 / 104 (2.88%)	8 / 106 (7.55%)	3 / 107 (2.80%)	1 / 53 (1.89%)	3 / 52 (5.77%)
occurrences all number	3	11	3	1	3
Aspartate aminotransferase increased
subjects affected / exposed	1 / 104 (0.96%)	7 / 106 (6.60%)	0 / 107 (0.00%)	1 / 53 (1.89%)	1 / 52 (1.92%)
occurrences all number	1	8	0	1	1
Blood creatine phosphokinase increased
subjects affected / exposed	5 / 104 (4.81%)	3 / 106 (2.83%)	5 / 107 (4.67%)	5 / 53 (9.43%)	1 / 52 (1.92%)
occurrences all number	5	3	7	6	1
Nervous system disorders
Headache
subjects affected / exposed	11 / 104 (10.58%)	7 / 106 (6.60%)	5 / 107 (4.67%)	4 / 53 (7.55%)	2 / 52 (3.85%)
occurrences all number	17	10	6	7	3
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 104 (0.96%)	2 / 106 (1.89%)	1 / 107 (0.93%)	3 / 53 (5.66%)	0 / 52 (0.00%)
occurrences all number	1	2	1	4	0
Nausea
subjects affected / exposed	4 / 104 (3.85%)	6 / 106 (5.66%)	3 / 107 (2.80%)	1 / 53 (1.89%)	0 / 52 (0.00%)
occurrences all number	4	6	3	3	0
Musculoskeletal and connective tissue disorders
Spinal pain
subjects affected / exposed	1 / 104 (0.96%)	3 / 106 (2.83%)	2 / 107 (1.87%)	0 / 53 (0.00%)	3 / 52 (5.77%)
occurrences all number	1	3	2	0	4
Infections and infestations
Nasopharyngitis
subjects affected / exposed	12 / 104 (11.54%)	11 / 106 (10.38%)	8 / 107 (7.48%)	4 / 53 (7.55%)	4 / 52 (7.69%)
occurrences all number	13	14	9	4	5
Pharyngitis
subjects affected / exposed	6 / 104 (5.77%)	7 / 106 (6.60%)	5 / 107 (4.67%)	3 / 53 (5.66%)	0 / 52 (0.00%)
occurrences all number	6	9	5	3	0
Upper respiratory tract infection
subjects affected / exposed	11 / 104 (10.58%)	8 / 106 (7.55%)	10 / 107 (9.35%)	5 / 53 (9.43%)	5 / 52 (9.62%)
occurrences all number	11	9	13	6	5
Urinary tract infection
subjects affected / exposed	4 / 104 (3.85%)	4 / 106 (3.77%)	2 / 107 (1.87%)	4 / 53 (7.55%)	1 / 52 (1.92%)
occurrences all number	5	4	4	4	1

More information

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Were there any global substantial amendments to the protocol? Yes

14 May 2013

This amendment included country-specific requirement for participants in Taiwan to be >20 years old for inclusion, updated footnotes of schedule of activities to show that collection of banked biospecimens were not mandatory per regulatory feedback, exclusion criterion 6d revised absolute lymphocyte count from <0.5 × 109/L (<500 mm3) to <1.0 × 109/L (<1000 mm3) as exclusion criterion per regulatory feedback (EU Competent Authorities that participated in the Voluntary Harmonization Procedure for Clinical Trial Applications).

13 Dec 2013

Inclusion criterion 1: clarified PsA criteria for enrollment to state that a participant had signs and symptoms consistent with the diagnosis of PsA for at least 6 months. Inclusion criterion 6: standardised washout of biologics to 6 months per regulatory agency request (Canada Health Ministry). Addition of ‘localised’ infection to exclusion criterion 15 per regulatory agency request (German BfArM). Addition of new exclusion criterion (26) for participants at risk of gastrointestinal perforation per latest Investigator’s Brochure. Clarification of use of sexual abstinence as contraceptive method only when consistent with preferred and usual participant lifestyle, per regulatory agency request (UK Ethics Committee). Added contraception advice for adalimumab: participants were advised to use effective contraception for 5 months following administration of the injectable medication or as per local adalimumab label/summary of product characteristics.

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) or Adalimumab in Subjects With Active Psoriatic Arthritis

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 ≥20% (ACR20): Month 3

Primary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥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: Change From Baseline in the Van der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis at Month 12

Secondary: Change From Baseline in the Van der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis at Month 12

Secondary: Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12

Secondary: Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12

Secondary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12

Secondary: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 2 and Months 1, 2, 4, 6, 9, and 12

Secondary: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 2 and Months 1, 2, 4, 6, 9, and 12

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count at Month 3

Secondary: Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count at Month 3

Secondary: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Secondary: Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Secondary: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response at Months 1, 3, 6, 9, and 12

Secondary: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12

Secondary: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Dactylitis Severity Score (DSS) at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Dactylitis Severity Score (DSS) at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Leeds Enthesitis Index (LEI) at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Leeds Enthesitis Index (LEI) at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain at Months 1, 3, 6, 9, and 12

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 at Months 1, 3, 6, 9, and 12

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 at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Self-care at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Self-care at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Usual Activities at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Usual Activities at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Pain/Discomfort at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Pain/Discomfort at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Anxiety/Depression at Months 1, 3, 6, 9, and 12

Secondary: Change From Baseline in Score on EQ-5D and Change in Patient's Self-rated Health on a Vertical VAS Recorded on the EQ-VAS: Anxiety/Depression at Months 1, 3, 6, 9, and 12

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) or Adalimumab in Subjects With Active Psoriatic Arthritis