OPAL BROADEN: Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01877668
• Collaborator: (none)
• Enrollment: 422
• Locations: 123
• Arms: 5
• Actual Duration (Months): 22.9
• Patients Per Site: 3.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Tofacitinib 5 mg BID; Drug: Tofacitinib 10 mg BID; Drug: Adalimumab; Drug: Placebo; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 422 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 20, 2014
• Actual Primary Completion Date: Dec 18, 2015
• Actual Study Completion Date: Dec 18, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tofacitinib 5 mgBID x 12 months	Drug: Tofacitinib 5 mg BID; Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Experimental: Tofacitinib 10 mg BID x 12 months	Drug: Tofacitinib 10 mg BID; Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Active Comparator: Adalimumab 40 mg q2 weeks x 12 months	Drug: Adalimumab; Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months	Drug: Placebo; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months	Drug: Placebo; Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 [At end of Month 3]

   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).

2. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score [From Baseline to Month 3]

   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.

Secondary Outcome Measures

1. Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis [From Baseline to Month 12]

   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.

2. Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 [At Month 12]

   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.

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

   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.

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

   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. .

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

   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.

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

   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.

7. Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels [From Baseline to end of Month 3]

   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.

8. Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain [From Baseline to end of Month 3]

   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.

9. Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis [From Baseline to end of Month 3]

   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 by placing a mark on the scale between 0 (very well) and 100 (very poorly).

10. Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis [From Baseline to end of Month 3]

    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 by placing a mark on the scale between 0 (very good) and 100 (very poor).

11. Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count [From Baseline to end of Month 3]

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

12. Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count [From Baseline to end of Month 3]

    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.

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

    The PsARC covers 4 measures: Tender/painful 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.

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

    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 a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).

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

    PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to 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 assigned a 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, sum of severity rating scores is multiplied by the score representing the percentage of 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 numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.

16. Change From Baseline in Dactylitis Severity Score (DSS) [From Baseline to Months 1, 3, 6, 9, and 12]

    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.

17. Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [From Baseline to Months 1, 3, 6, 9, and 12]

    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.

18. Change From Baseline in the Leeds Enthesitis Index (LEI) [From Baseline to Months 1, 3, 6, 9, and 12]

    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 that are affected by enthesitis.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.

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

    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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.

29. 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 [From Baseline to Months 1, 3, 6, 9, and 12]

    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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.

30. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care [From Baseline to Months 1, 3, 6, 9, and 12]

    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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.

31. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities [From Baseline to Months 1, 3, 6, 9, and 12]

    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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.

32. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort [From Baseline to Months 1, 3, 6, 9, and 12]

    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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.

33. Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression [From Baseline to Months 1, 3, 6, 9, and 12]

    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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.

34. 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): Patient's Health State Today [From Baseline to Months 1, 3, 6, 9, and 12]

    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 [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.

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

    FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). 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 to 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. Higher scores represent better fatigue status.

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

    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. Higher scores represent better (less) fatigue experience.

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

    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. Higher scores represent better (less) fatigue impact on daily functioning.

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

    BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females, aged >= 18 years at time of consent.

• Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months

• Meet the Classification Criteria of PsA (CASPAR) at time of screening

• Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).

• Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required

• Must not have taken a biologic Tumour Necrosis Factor Inhibitor

• Must have 3 or more swollen joints AND 3 or more tender joints

• Must have active psoriasis skin lesions

Exclusion Criteria:

• Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed

• Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception

• New York Heart Association Class III and IV congestive heart failure

• History of hypersensitivity or infusion reaction to biologic agents

• Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheumatology Associates, PC	Birmingham	Alabama	United States	35205
2	Rheumatology Associates of North Alabama, PC	Huntsville	Alabama	United States	35801
3	Arizona Arthritis & Rheumatology Associates, P.C.	Glendale	Arizona	United States	85306
4	Medvin Clinical Research	Covina	California	United States	91723
5	Desert Medical Advances	Palm Desert	California	United States	92260
6	Advances In Medicine (X-Rays)	Rancho Mirage	California	United States	92270
7	San Diego Arthritis Medical Clinic	San Diego	California	United States	92108
8	Millennium Research	Ormond Beach	Florida	United States	32174
9	Arthritis Center, Inc.	Palm Harbor	Florida	United States	34684
10	Klein & Associates, M.D., P.A.	Hagerstown	Maryland	United States	21740
11	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01605
12	St. Paul Rheumatology, PA	Eagan	Minnesota	United States	55121
13	Physician Research Collaboration, LLC	Lincoln	Nebraska	United States	68516
14	Dartmouth-Hitchcock Medical Center (DHMC)	Lebanon	New Hampshire	United States	03756
15	Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio	United States	44130
16	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
17	Low Country Rheumatology, PA	Charleston	South Carolina	United States	29406
18	Pioneer Research Solutions, Inc.	Houston	Texas	United States	77008
19	Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah	Salt Lake City	Utah	United States	84112
20	University of Utah Hospital & Clinics	Salt Lake City	Utah	United States	84132
21	Dynacare Laboratories (Specimen processing for shipment)	Seattle	Washington	United States	98122
22	Investigational Drug Service Pharmacy, Swedish Medical Center.	Seattle	Washington	United States	98122
23	Seattle Rheumatology Associates	Seattle	Washington	United States	98122
24	Swedish Medical Center	Seattle	Washington	United States	98122
25	Rheumatology Research Unit	Maroochydore	Queensland	Australia	4558
26	Pacific Private Clinic	Southport	Queensland	Australia	4215
27	Monash Health, Monash Medical Centre	Clayton	Victoria	Australia	3168
28	Pharmacy Clinical Trials	Clayton	Victoria	Australia	3168
29	St. Vincent's Hospital (Melbourne)	Fitzroy	Victoria	Australia	3065
30	Emeritus Research Pty Ltd	Malvern East	Victoria	Australia	3145
31	Hopital Erasme - Clinique Universitaire de Bruxelles	Brussels		Belgium	1070
32	University Hospital Leuven, Department of Rheumatology	Leuven		Belgium	3000
33	UMHAT "Dr. G. Stranski" EAD	Pleven		Bulgaria	5800
34	MHAT"Plovdiv" AD	Plovdiv		Bulgaria	4000
35	MHAT "Kaspela" EOOD	Plovdiv		Bulgaria	4002
36	UMHAT "Sv. Ivan Rilski" EAD	Sofia		Bulgaria	1612
37	MC "New rehabilitation center" EOOD, Rheumatology Cabinet	Stara Zagora		Bulgaria	6003
38	Rheumatology Research Associates	Edmonton	Alberta	Canada	T5M 0H4
39	K. Papp Clinical Research	Waterloo	Ontario	Canada	N2J 1C4
40	West Island Rheumatology Research Associates	Pointe-Claire	Quebec	Canada	H9R 3J1
41	Revmacentrum MUDr. Mostera, s.r.o.	Brno	Czech Republic	Czechia	615 00
42	MEDIGAP, s.r.o. (radiology only)	Praha 1 - Nove Mesto	Czech Republic	Czechia	110 00
43	Revmatologicky Ustav - Lekarna (pharmacy only)	Praha 2	Czech Republic	Czechia	128 50
44	Revmatologicka ambulance	Praha 4	Czech Republic	Czechia	140 00
45	Lekarna Na Lidicke (Pharmacy only)	Brno		Czechia	602 00
46	X-MEDICA s.r.o (radiology only)	Brno		Czechia	61300
47	Revmatologie s.r.o.	Brno		Czechia	638 00
48	Stavovska s.r.o. (pharmacy only)	Brno		Czechia	63800
49	Vesalion s.r.o.	Ostrava		Czechia	70200
50	MEDIGAP, s.r.o	Praha 1- Nove Mesto		Czechia	110 00
51	Revmatologicky ustav - Lekarna	Praha 2		Czechia	128 50
52	Revmatologicky ustav	Praha 2		Czechia	128 50
53	Medical Plus s.r.o. Lekarna Hradebni s. r.o	Uherske Hradiste		Czechia	68601
54	Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie	Corbeil Essonnes cedex		France	91106
55	Charite Universitaetsmedizin Berlin	Berlin		Germany	10117
56	Klinische Forschung Berlin-Mitte GmbH	Berlin		Germany	10117
57	Rheumapraxis Steglitz	Berlin		Germany	12161
58	University Hospital of Cologne	Koeln		Germany	50937
59	Klinische Forschung Schwerin GmbH	Schwerin		Germany	19055
60	Revita Reumatologiai Rendelo	Budapest		Hungary	1027
61	Qualiclinic Kft.	Budapest		Hungary	1036
62	Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly	Budapest		Hungary	1062
63	Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only	Veszprem		Hungary	8200
64	Csolnoky Ferenc Korhaz, Reumatologiai Osztaly	Veszprem		Hungary	8200
65	Centro Integral en Reumatologia SA de CV	Guadalajara	Jalisco	Mexico	44160
66	Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.	Culiacan	Sinaloa	Mexico	80000
67	Laboratorios de Analisis Clinicos CEMSI	Culiacan	Sinaloa	Mexico	80000
68	Sanatorio CEMSI Chapultepec (For Emergencies Only)	Culiacan	Sinaloa	Mexico	80040
69	Hospital General de Culiacán Dr. Bernardo J. Gastélum	Culiacan	Sinaloa	Mexico	80230
70	Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)	Merida	Yucatan	Mexico	97000
71	Unidad Reumatologica Las Americas, S.C.P.	Merida	Yucatan	Mexico	97000
72	Centro de Investigacion Clinica Pensiones	Merida	Yucatan	Mexico	97070
73	Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan	Merida	Yucatan	Mexico	97130
74	Hospital Star Medica Merida (For Emergencies Only)	Merida	Yucatan	Mexico	97133
75	HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)	Merida	Yucatan	Mexico	97133
76	Investigacion y Biomedicina de Chihuahua SC	Chihuahua		Mexico	31000
77	Cliditer, S. A. de C. V	Mexico City		Mexico	06700
78	Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"	Bialystok		Poland	15-002
79	ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik	Bialystok		Poland	15-351
80	ClinicMed Badurski i wspolnicy Spolka Jawna	Bialystok		Poland	15-879
81	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,	Bydgoszcz		Poland	85-168
82	Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska	Elblag		Poland	82-300
83	Centrum Radiologii for X-Ray only	Elblag		Poland	82-300
84	NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela	Elblag		Poland	82-300
85	Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"	Grodzisk Mazowiecki		Poland	05-825
86	Zespol Poradni Specjalistycznych Reumed Filia Onyksowa	Lublin		Poland	20-582
87	NZOZ Lecznica MAK-MED S.C.	Nadarzyn		Poland	05-830
88	Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj	Poznan		Poland	61-397
89	NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu	Torun		Poland	87-100
90	Medica Pro Familia Sp. z o.o. S.K.A.	Warsaw		Poland	01-868
91	Rheuma Medicus Zaklad Opieki Zdrowotnej	Warszawa		Poland	02-118
92	Reumatika Centrum Reumatologii	Warszawa		Poland	02-691
93	Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A	Warszawa		Poland	02-758
94	Synexus Polska Sp. z o.o. Oddz. we Wroclawiu	Wroclaw		Poland	50-088
95	Regional State Budgetary Healthcare Institution of Karelia Republic	Petrozavodsk	Karelia Republic	Russian Federation	185019
96	State Budgetary Institution of Healthcare of Moscow City Clinical Hospital	Moscow		Russian Federation	119049
97	OOO City Neurological Centre "Sibneiromed"	Novosibirsk		Russian Federation	630091
98	Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"	Novosibirsk		Russian Federation	630099
99	State Institution of Healthcare "Regional Clinical Hospital"	Saratov		Russian Federation	410053
100	State Budget Educational Institution of Highest Professional Education	Tomsk		Russian Federation	634050
101	State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev	Yaroslavl		Russian Federation	150003
102	State Institution of Healthcare of Yaroslavl Region	Yaroslavl		Russian Federation	150003
103	ROMJAN s.r.o., Reumatologicka ambulancia	Bratislava	Slovak Republic	Slovakia	832 63
104	MEDMAN s.r.o. - reumatologicka ambulancia	Martin	Slovak Republic	Slovakia	036 01
105	Nestatna reumatologicka ambulancia	Bratislava		Slovakia	841 04
106	Reumex s.r.o	Rimavska Sobota		Slovakia	979 01
107	Hospital Clinico de Santiago	Santiago De Compostela	A Coruna	Spain	15706
108	Corporació Sanitaria Parc Tauli	Sabadell	Barcelona	Spain	08208
109	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
110	Complexo Hospitalario Universitario A Coruna	A Coruna		Spain	15006
111	Hospital Infanta Luisa	Sevilla		Spain	41010
112	Hospital Universitario y Politecnico La Fe	Valencia		Spain	46026
113	Taipei Veterans General Hospital	Taipei	Taiwan Roc	Taiwan	11217
114	Buddhist Dalin Tzu Chi General Hospital	Chia-Yi		Taiwan	62247
115	Chang Gung Medical Foundation-Kaohsiung Branch	Kaohsiung		Taiwan	83301
116	Chung Shan Medical University Hospital	Taichung		Taiwan	40201
117	Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital	Goodmayes	Essex	United Kingdom	IG3 8YB
118	Barking, Havering and Redbridge University Hospitals NHS Trust	Romford	Essex	United Kingdom	RM7 0AG
119	The Dudley Group NHS Foundation Trust	Dudley	West Midlands	United Kingdom	DY1 2HQ
120	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	West Yorkshire	United Kingdom	BD5 0NA
121	Bradford Royal Infirmary, BTHFT	Bradford	West Yorkshire	United Kingdom	BD9 6RJ
122	Wirral University Teaching Hospital NHS Foundation Trust	Upton	Wirral	United Kingdom	CH49 5PE
123	York Teaching Hospital NHS Foundation Trust	York		United Kingdom	YO31 8HE

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01877668
• Other Study ID Numbers: A3921091; 2011-003668-55
• First Posted: Jun 14, 2013
• Last Update Posted: Jul 6, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pfizer: psoriatic arthritis; radiographic changes; active comparator; tofacitinib
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic; Adalimumab; Tofacitinib

Study Results

Participant Flow

Pre-assignment Detail	Of 611 participants screened for entry into the study, 422 received treatment.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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.
Period Title: Overall Study
STARTED	107	104	106	52	53
COMPLETED	96	96	94	44	43
NOT COMPLETED	11	8	12	8	10

Baseline Characteristics

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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.	Total of all reporting groups
Overall Participants	107	104	106	52	53	422
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.4 (12.6)	46.9 (12.4)	47.4 (11.3)	46.1 (10.4)	49.3 (13.8)	47.9 (12.1)
Sex: Female, Male (Count of Participants)
Female	57 53.3%	62 59.6%	50 47.2%	28 53.8%	28 52.8%	225 53.3%
Male	50 46.7%	42 40.4%	56 52.8%	24 46.2%	25 47.2%	197 46.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3
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).
Time Frame	At end of Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized and received at least 1 dose of study drug.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	105
Number [Percentage or participants]	50.47 47.2%	60.58 58.3%	51.89 49%	33.33 64.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib, 5 mg, Twice Daily, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0102
	Comments
	Method	Large sample approximation
	Comments	Missing response (MR)=non-response (NR)
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	17.13
	Confidence Interval	(2-Sided) 95%; 4.06 to 30.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.67
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib, 10 mg, Twice Daily, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Large sample approximation
	Comments	MR=NR
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	27.24
	Confidence Interval	(2-Sided) 95%; 14.22 to 40.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.64
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adalimumab, 40 mg, Every 2 Weeks, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0055
	Comments
	Method	Large sample approximation
	Comments	MR=NR
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	18.55
	Confidence Interval	(2-Sided) 95%; 5.45 to 31.66
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.69
	Estimation Comments

2. Primary Outcome

Title	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
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.
Time Frame	From Baseline to Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	104
Least Squares Mean (Standard Error) [Units on a scale]	-0.3499 (0.04665)	-0.3998 (0.04716)	-0.3808 (0.04767)	-0.1802 (0.05031)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib, 5 mg, Twice Daily, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0062
	Comments
	Method	Mixed Models Analysis
	Comments	No imputation.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1697
	Confidence Interval	(2-Sided) 95%; -0.2910 to -0.0483
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06173
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tofacitinib, 10 mg, Twice Daily, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Mixed Models Analysis
	Comments	No imputation.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2196
	Confidence Interval	(2-Sided) 95%; -0.3411 to -0.0980
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06184
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adalimumab, 40 mg, Every 2 Weeks, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	Mixed Models Analysis
	Comments	No imputation.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2005
	Confidence Interval	(2-Sided) 95%; -0.3213 to -0.0797
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06145
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis
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.
Time Frame	From Baseline to Month 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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
Measure Participants	98	99	95	48	45
Least Squares Mean (Standard Error) [Units on a scale]	0.01 (0.067)	-0.01 (0.067)	-0.07 (0.069)	0.00 (0.094)	0.09 (0.099)

4. Secondary Outcome

Title	Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12
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.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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.
Measure Participants	98	99	95	48	45
Number [Percentage of participants]	4.08 3.8%	5.05 4.9%	2.11 2%	4.17 8%	8.89 16.8%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	52	53	105
Week 2 (n=7, 7, 5, NA, NA, 1)	6.54 6.1%	6.73 6.5%	4.72 4.5%	NA NaN	NA NaN	0.95 0.2%
Month 1 (n=13, 20,12, NA, NA, 5)	12.15 11.4%	19.23 18.5%	11.32 10.7%	NA NaN	NA NaN	4.76 1.1%
Month 2 (n=23, 34, 24, NA, NA, 8)	21.50 20.1%	32.69 31.4%	22.64 21.4%	NA NaN	NA NaN	7.62 1.8%
Month 3 (n=30, 42, 35, NA, NA, 10)	28.04 26.2%	40.38 38.8%	33.02 31.2%	NA NaN	NA NaN	9.52 2.3%
Month 4 (n=38, 39, 34, 11, 17, NA)	35.51 33.2%	37.50 36.1%	32.08 30.3%	21.15 40.7%	32.08 60.5%	NA NaN
Month 6 (n=41, 48, 45, 17, 14, NA)	38.32 35.8%	46.15 44.4%	42.45 40%	32.69 62.9%	26.42 49.8%	NA NaN
Month 9 (n=45, 48, 49, 22, 23, NA)	42.06 39.3%	46.15 44.4%	46.23 43.6%	42.31 81.4%	43.40 81.9%	NA NaN
Month 12 (n=48, 50, 43, 21, 19, NA)	44.86 41.9%	48.08 46.2%	40.57 38.3%	40.38 77.7%	35.85 67.6%	NA NaN

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	52	53	105
Week 2 (n=0, 3, 1, NA, NA, 0)	0.00 0%	2.88 2.8%	0.94 0.9%	NA NaN	NA NaN	0.00 0%
Month 1 (n=5, 8, 4, NA, NA, 1)	4.67 4.4%	7.69 7.4%	3.77 3.6%	NA NaN	NA NaN	0.95 0.2%
Month 2 (n=10, 14, 13, NA, NA, 2)	9.35 8.7%	13.46 12.9%	12.26 11.6%	NA NaN	NA NaN	1.90 0.5%
Month 3 (n=18, 15, 20, NA, NA, 5)	16.82 15.7%	14.42 13.9%	18.87 17.8%	NA NaN	NA NaN	4.76 1.1%
Month 4 (n=24, 23, 21, 7, 8, NA)	22.43 21%	22.12 21.3%	19.81 18.7%	13.46 25.9%	15.09 28.5%	NA NaN
Month 6 (n=19, 33, 32, 10, 7, NA)	17.76 16.6%	31.73 30.5%	30.19 28.5%	19.23 37%	13.21 24.9%	NA NaN
Month 9 (n=21, 31, 30, 15, 12, NA)	19.63 18.3%	29.81 28.7%	28.30 26.7%	28.85 55.5%	22.64 42.7%	NA NaN
Month 12 (n=25, 32, 31, 12, 12, NA)	23.36 21.8%	30.77 29.6%	29.25 27.6%	23.08 44.4%	22.64 42.7%	NA NaN

7. Secondary Outcome

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
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.
Time Frame	At Week 2 and Months 1, 2, 4, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	52	53	105
Week 2 (n=24, 33, 23, NA, NA, 6)	22.43 21%	31.73 30.5%	21.70 20.5%	NA NaN	NA NaN	5.71 1.4%
Month 1 (n=37, 50, 30, NA, NA, 11)	34.58 32.3%	48.08 46.2%	28.30 26.7%	NA NaN	NA NaN	10.48 2.5%
Month 2 (n=47, 57, 62, NA, NA, 28)	43.93 41.1%	54.81 52.7%	58.49 55.2%	NA NaN	NA NaN	26.67 6.3%
Month 4 (n=65, 60, 61, 27, 28, NA)	60.75 56.8%	57.69 55.5%	57.55 54.3%	51.92 99.8%	52.83 99.7%	NA NaN
Month 6 (n=63, 70, 68, 31, 30, NA)	58.88 55%	67.31 64.7%	64.15 60.5%	59.62 114.7%	56.60 106.8%	NA NaN
Month 9 (n=73, 76, 73, 35, 37, NA)	68.22 63.8%	73.08 70.3%	68.87 65%	67.31 129.4%	69.81 131.7%	NA NaN
Month 12 (n=73, 73, 64, 35, 31, NA)	68.22 63.8%	70.19 67.5%	60.38 57%	67.31 129.4%	58.49 110.4%	NA NaN

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	52	52	104
Week 2 (n=106, 102, 103, NA, NA, 102)	-0.1842 (0.04131)	-0.2089 (0.04208)	-0.2129 (0.04246)	NA (NA)	NA (NA)	-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)	NA (NA)	NA (NA)	-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)	NA (NA)	NA (NA)	-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)	-0.2850 (0.07075)	-0.3302 (0.07128)	NA (NA)
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)	NA (NA)
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)	NA (NA)
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)	NA (NA)

9. Secondary Outcome

Title	Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels
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.
Time Frame	From Baseline to end of Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	104
Least Squares Mean (Standard Error) [mg/L]	-5.5981 (0.80656)	-6.6004 (0.80822)	-7.8955 (0.82547)	-0.8643 (0.86304)

10. Secondary Outcome

Title	Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain
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.
Time Frame	From Baseline to end of Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	105	104
Least Squares Mean (Standard Error) [mm]	-21.49 (2.325)	-27.10 (2.342)	-21.87 (2.389)	-10.22 (2.499)

11. Secondary Outcome

Title	Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis
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 by placing a mark on the scale between 0 (very well) and 100 (very poorly).
Time Frame	From Baseline to end of Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	104
Least Squares Mean (Standard Error) [mm]	-20.08 (2.275)	-25.50 (2.291)	-21.47 (2.328)	-11.40 (2.439)

12. Secondary Outcome

Title	Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis
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 by placing a mark on the scale between 0 (very good) and 100 (very poor).
Time Frame	From Baseline to end of Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	103	106	104
Least Squares Mean (Standard Error) [mm]	-27.44 (1.998)	-33.74 (2.021)	-29.02 (2.043)	-22.26 (2.121)

13. Secondary Outcome

Title	Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count
Description	Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.
Time Frame	From Baseline to end of Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	104
Least Squares Mean (Standard Error) [Joints]	-6.5 (0.58)	-7.6 (0.58)	-6.5 (0.59)	-4.8 (0.62)

14. Secondary Outcome

Title	Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count
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.
Time Frame	From Baseline to end of Month 3

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable.

Arm/Group Title	Tofacitinib, 5 mg, Twice Daily	Tofacitinib, 10 mg, Twice Daily	Adalimumab, 40 mg, Every 2 Weeks	Placebo
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	104
Least Squares Mean (Standard Error) [Joints]	-8.7 (1.04)	-11.0 (1.05)	-7.6 (1.07)	-6.9 (1.10)

15. Secondary Outcome

Title	Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Description	The PsARC covers 4 measures: Tender/painful 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.
Time Frame	At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized and received at least 1 dose of study drug. n=number of responders.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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.	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	107	104	106	52	53	105
Week 2 (n=34, 42, 23, NA, NA, 10)	31.78 29.7%	40.38 38.8%	21.70 20.5%	NA NaN	NA NaN	9.52 2.3%
Month 1 (n=45, 51, 43, NA, NA, 23)	42.06 39.3%	49.04 47.2%	40.57 38.3%	NA NaN	NA NaN	21.90 5.2%
Month 2 (n=54, 69, 62, NA, NA, 36)	50.47 47.2%	66.35 63.8%	58.49 55.2%	NA NaN	NA NaN	34.29 8.1%
Month 3 (n=55, 73, 65, NA, NA, 47)	51.40 48%	70.19 67.5%	61.32 57.8%	NA NaN	NA NaN	44.76 10.6%
Month 4 (n=68, 68, 71, 32, 30, NA)	63.55 59.4%	65.38 62.9%	66.98 63.2%	61.54 118.3%	56.60 106.8%	NA NaN
Month 6 (n=61, 75, 71, 35, 35, NA)	57.01 53.3%	72.12 69.3%	66.98 63.2%	67.31 129.4%	66.04 124.6%	NA NaN
Month 9 (n=75, 73, 71, 36, 37, NA)	70.09 65.5%	70.19 67.5%	66.98 63.2%	69.23 133.1%	69.81 131.7%	NA NaN
Month 12 (n=69, 76, 69, 39, 33, NA)	64.49 60.3%	73.08 70.3%	65.09 61.4%	75.00 144.2%	62.26 117.5%	NA NaN

16. Secondary Outcome

Title	Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response
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 a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO>0 and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	101	98	102	50	50	100
Month 1 (n=100, 96, 100, NA, NA, 99)	-0.7 (0.07)	-0.8 (0.08)	-0.5 (0.08)	NA (NA)	NA (NA)	-0.2 (0.08)
Month 3 (n=98, 97, 98, NA, NA, 98)	-1.0 (0.08)	-1.2 (0.08)	-1.0 (0.09)	NA (NA)	NA (NA)	-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)	NA (NA)
Month 9 (n=95, 91, 94, 45, 44, NA)	-1.0 (0.09)	-1.5 (0.09)	-1.2 (0.09)	-0.7 (0.12)	-1.3 (0.13)	NA (NA)
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)	NA (NA)

17. Secondary Outcome

Title	Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12
Description	PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to 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 assigned a 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, sum of severity rating scores is multiplied by the score representing the percentage of 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 numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.
Time Frame	At Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized and received at least 1 dose of study drug with PASI>0 and BSA ≥3% at baseline. n=number of responders.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	82	70	77	42	40	82
Month 1 (n=19, 19, 11, NA, NA, 4)	23.17 (4.66) 21.7%	27.14 (5.32) 26.1%	14.29 (3.99) 13.5%	NA (NA) NaN	NA (NA) NaN	4.88 (2.38) 1.2%
Month 3 (n=35, 31, 30, NA, NA, 12)	42.68 (5.46) 39.9%	44.29 (5.94) 42.6%	38.96 (5.56) 36.8%	NA (NA) NaN	NA (NA) NaN	14.63 (3.90) 3.5%
Month 6 (n=38, 42, 42, 12, 17, NA)	46.34 (5.51) 43.3%	60.00 (5.86) 57.7%	54.55 (5.67) 51.5%	28.57 (6.97) 54.9%	42.50 (7.82) 80.2%	NA (NA) NaN
Month 9 (n=36, 48, 45, 14, 20, NA)	43.90 (5.448) 41%	68.57 (5.55) 65.9%	58.44 (5.62) 55.1%	33.33 (7.27) 64.1%	50.00 (7.91) 94.3%	NA (NA) NaN
Month 12 (n=46, 47, 43, 15, 21, NA)	56.10 (5.48) 52.4%	67.14 (5.61) 64.6%	55.84 (5.66) 52.7%	35.71 (7.39) 68.7%	52.50 (7.90) 99.1%	NA (NA) NaN

18. Secondary Outcome

Title	Change From Baseline in Dactylitis Severity Score (DSS)
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.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug with baseline DSS>0 and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	60	60	58	29	28	57
Month 1 (n=58, 59, 56, NA, NA, 56)	-1.8 (0.91)	-3.1 (0.87)	-2.1 (0.93)	NA (NA)	NA (NA)	0.6 (1.02)
Month 3 (n=58, 60 , 56, NA, NA, 55)	-3.5 (0.95)	-5.5 (0.91)	-4.0 (0.97)	NA (NA)	NA (NA)	-2.0 (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 (1.50)	NA (NA)
Month 9 (n=57, 59, 53, 27, 25, NA)	-7.0 (0.60)	-7.2 (0.58)	-6.5 (0.63)	-5.3 (0.87)	-7.9 (0.89)	NA (NA)
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)	NA (NA)

19. Secondary Outcome

Title	Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
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.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score>0 and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	80	81	82	38	41	79
Month 1 (n=79, 80, 80, NA, NA, 78)	-0.83 (0.317)	-1.27 (0.321)	-0.95 (0.336)	NA (NA)	NA (NA)	-0.58 (0.355)
Month 3 (n=77, 79, 79, NA, NA, 78)	-1.84 (0.363)	-2.41 (0.364)	-1.90 (0.375)	NA (NA)	NA (NA)	-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 (0.50)	-2.5 (0.48)	NA (NA)
Month 9 (n=75, 75, 73, 34, 37, NA)	-2.9 (0.31)	-2.6 (0.32)	-3.0 (0.33)	-2.8 (0.46)	-3.2 (0.44)	NA (NA)
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)	NA (NA)

20. Secondary Outcome

Title	Change From Baseline in the Leeds Enthesitis Index (LEI)
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 that are affected by enthesitis.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug with baseline LEI>0 and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	74	64	76	31	34	65
Month 1 (n=74, 63, 75, NA, NA, 65)	-0.41 (0.192)	-0.57 (0.213)	-0.42 (0.203)	NA (NA)	NA (NA)	-0.26 (0.219)
Month 3 (n=70, 63, 73, NA, NA, 63)	-0.82 (0.221)	-1.46 (0.240)	-1.10 (0.228)	NA (NA)	NA (NA)	-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 (0.32)	-1.3 (0.30)	NA (NA)
Month 9 (n=70, 58, 68, 27, 29, NA)	-1.4 (0.20)	-1.3 (0.23)	-1.5 (0.21)	-1.4 (0.31)	-1.7 (0.30)	NA (NA)
Month 12 (n=67, 56, 67, 24, 29, NA)	-1.7 (0.19)	-1.6 (0.21)	-1.6 (0.20)	-1.4 (0.30)	-1.9 (0.28)	NA (NA)

21. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	3.39 (0.638)	4.66 (0.645)	4.00 (0.655)	NA (NA)	NA (NA)	1.54 (0.700)
Month 3 (n=102, 103,100, NA, NA, 102)	5.51 (0.733)	5.69 (0.735)	6.23 (0.748)	NA (NA)	NA (NA)	2.68 (0.785)
Month 6 (n=100, 100, 98, 48, 48, NA)	6.72 (0.773)	6.70 (0.777)	6.26 (0.788)	5.86 (1.101)	6.07 (1.112)	NA (NA)
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 (1.130)	NA (NA)
Month 12 (n=96, 96, 94, 44, 43, NA)	7.61 (0.806)	7.67 (0.810)	6.74 (0.822)	5.82 (1.160)	5.72 (1.177)	NA (NA)

22. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104,NA, NA, 103)	4.12 (0.841)	3.63 (0.849)	2.13 (0.871)	NA (NA)	NA (NA)	3.19 (0.917)
Month 3 (n=102, 103,100, NA, NA, 102)	4.35 (0.909)	4.20 (0.909)	3.13 (0.938)	NA (NA)	NA (NA)	3.27 (0.976)
Month 6 (n=100, 100, 98, 48, 48, NA)	5.70 (0.927)	5.51 (0.930)	4.58 (0.955)	4.50 (1.319)	3.62 (1.331)	NA (NA)
Month 9 (n=99, 97, 95, 47, 46, NA)	5.07 (0.974)	6.20 (0.982)	3.68 (1.005)	4.61 (1.391)	6.03 (1.409)	NA (NA)
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)	NA (NA)

23. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	2.43 (0.768)	3.89 (0.776)	2.81 (0.787)	NA (NA)	NA (NA)	1.10 (0.840)
Month 3 (n=102, 103,101, NA, NA, 102)	5.17 (0.846)	5.23 (0.848)	5.22 (0.862)	NA (NA)	NA (NA)	2.06 (0.910)
Month 6 (n=100, 100, 99, 48, 48, NA)	7.02 (0.897)	6.15 (0.900)	6.36 (0.912)	5.22 (1.276)	5.22 (1.291)	NA (NA)
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)	NA (NA)
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)	NA (NA)

24. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	4.05 (0.751)	3.72 (0.759)	4.09 (0.770)	NA (NA)	NA (NA)	1.98 (0.820)
Month 3 (n=102, 103, 100, NA, NA, 102)	4.45 (0.801)	4.79 (0.803)	5.21 (0.820)	NA (NA)	NA (NA)	3.63 (0.862)
Month 6 (n=100, 100, 99, 48, 48, NA)	6.02 (0.824)	5.21 (0.828)	5.48 (0.840)	4.97 (1.172)	5.03 (1.185)	NA (NA)
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)	6.70 (1.234)	NA (NA)
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)	NA (NA)

25. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	5.53 (0.777)	7.16 (0.786)	6.42 (0.802)	NA (NA)	NA (NA)	3.44 (0.851)
Month 3 (n=102, 103, 101, NA, NA, 102)	7.75 (0.838)	8.05 (0.840)	7.52 (0.859)	NA (NA)	NA (NA)	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)	NA (NA)
Month 9 (n=99, 97, 96, 47, 46, NA)	9.03 (0.953)	10.13 (0.960)	8.59 (0.977)	8.46 (1.362)	10.81 (1.389)	NA (NA)
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)	NA (NA)

26. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	3.29 (0.610)	3.87 (0.616)	1.96 (0.625)	NA (NA)	NA (NA)	2.15 (0.666)
Month 3 (n=102, 103,101, NA, NA, 102 )	4.09 (0.700)	3.95 (0.701)	4.73 (0.713)	NA (NA)	NA (NA)	2.64 (0.748)
Month 6 (n=100, 100, 99, 48, 48, NA)	5.96 (0.720)	4.12 (0.722)	4.81 (0.733)	4.39 (1.022)	3.92 (1.033)	NA (NA)
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)	NA (NA)
Month 12 (n=96, 96, 94, 44, 44, NA)	5.70 (0.811)	4.63 (0.815)	4.21 (0.825)	4.50 (1.164)	4.12 (1.175)	NA (NA)

27. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	3.64 (0.802)	4.59 (0.806)	2.42 (0.826)	NA (NA)	NA (NA)	2.16 (0.877)
Month 3 (n=102, 103, 101, NA, NA, 102)	5.50 (0.889)	5.90 (0.887)	4.93 (0.909)	NA (NA)	NA (NA)	3.05 (0.954)
Month 6 (n=100, 100, 99, 48, 48, NA)	6.81 (0.969)	7.41 (0.970)	5.05 (0.989)	5.34 (1.378)	4.62 (1.394)	NA (NA)
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)	NA (NA)
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)	NA (NA)

28. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	4.51 (0.827)	4.46 (0.838)	3.34 (0.852)	NA (NA)	NA (NA)	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)	NA (NA)	NA (NA)	3.63 (0.961)
Month 6 (n=100, 100, 99, 48, 48, NA)	6.97 (0.955)	7.08 (0.959)	7.10 (0.975)	5.44 (1.362)	6.05 (1.373)	NA (NA)
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)	NA (NA)
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)	NA (NA)

29. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103,104, NA, NA, 103)	4.77 (0.960)	3.87 (0.971)	2.93 (0.991)	NA (NA)	NA (NA)	4.52 (1.042)
Month 3 (n=102, 103, 100, NA, NA, 102)	4.21 (1.010)	4.82 (1.011)	3.35 (1.040)	NA (NA)	NA (NA)	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)	NA (NA)
Month 9 (n=99, 97, 95, 47, 46, NA)	5.13 (1.021)	6.13 (1.030)	4.87 (1.052)	5.89 (1.456)	6.52 (1.478)	NA (NA)
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)	NA (NA)

30. Secondary Outcome

Title	Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain
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. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	3.32 (0.867)	3.87 (0.874)	2.79 (0.895)	NA (NA)	NA (NA)	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)	NA (NA)	NA (NA)	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)	3.70 (1.354)	3.41 (1.372)	NA (NA)
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)	NA (NA)
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)	NA (NA)

31. Secondary Outcome

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
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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	-0.07 (0.042)	-0.19 (0.043)	-0.15 (0.043)	NA (NA)	NA (NA)	-0.10 (0.046)
Month 3 (n=101, 103, 101, NA, NA, 102)	-0.28 (0.047)	-0.27 (0.047)	-0.29 (0.048)	NA (NA)	NA (NA)	-0.11 (0.050)
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)	NA (NA)
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)	NA (NA)
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)	NA (NA)

32. Secondary Outcome

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): Self-care
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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	103	106	52	52	104
Month 1 (n=105, 102, 104, NA, NA, 103)	-0.11 (0.046)	-0.16 (0.047)	-0.16 (0.047)	NA (NA)	NA (NA)	-0.09 (0.050)
Month 3 (n=101, 102, 101, NA, NA, 102)	-0.19 (0.047)	-0.11 (0.047)	-0.18 (0.048)	NA (NA)	NA (NA)	-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)	NA (NA)
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)	NA (NA)
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)	NA (NA)

33. Secondary Outcome

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): Usual Activities
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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	103	106	52	52	104
Month 1 (n=105, 102, 104, NA, NA, 103)	-0.17 (0.043)	-0.19 (0.043)	-0.21 (0.044)	NA (NA)	NA (NA)	-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)	NA (NA)	NA (NA)	-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)	NA (NA)
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)	NA (NA)
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)	NA (NA)

34. Secondary Outcome

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): Pain/Discomfort
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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	-0.14 (0.039)	-0.25 (0.040)	-0.19 (0.040)	NA (NA)	NA (NA)	-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)	NA (NA)	NA (NA)	-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)	NA (NA)
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)	NA (NA)
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)	NA (NA)

35. Secondary Outcome

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): Anxiety/Depression
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 [1], some or moderate problems [2], or extreme problems [3]) 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, with a higher value representing better health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	-0.25 (0.051)	-0.22 (0.052)	-0.27 (0.053)	NA (NA)	NA (NA)	-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)	NA (NA)	NA (NA)	-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)	NA (NA)
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)	NA (NA)
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)	NA (NA)

36. Secondary Outcome

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): Patient's Health State Today
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 [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	10.75 (1.859)	10.81 (1.880)	10.27 (1.917)	NA (NA)	NA (NA)	6.59 (2.027)
Month 3 (n=101, 103, 101, NA, NA, 101)	14.00 (2.100)	15.83 (2.092)	13.10 (2.138)	NA (NA)	NA (NA)	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 (3.00)	NA (NA)
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)	NA (NA)
Month 12 (n=96, 96, 94, 44, 44, NA)	20.7 (2.09)	19.8 (2.09)	16.5 (2.14)	16.0 (3.02)	19.8 (3.05)	NA (NA)

37. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score
Description	FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). 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 to 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. Higher scores represent better fatigue status.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	5.2 (0.77)	4.4 (0.78)	4.2 (0.79)	NA (NA)	NA (NA)	2.7 (0.84)
Month 3 (102, 102, 101, NA, NA, 102)	7.0 (0.85)	6.0 (0.85)	6.0 (0.87)	NA (NA)	NA (NA)	3.3 (0.91)
Month 6 (n=100, 100, 99,48, 48, NA)	7.9 (0.89)	8.0 (0.89)	6.5 (0.91)	6.5 (1.26)	7.2 (1.28)	NA (NA)
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)	NA (NA)
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)	NA (NA)

38. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score
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. Higher scores represent better (less) fatigue experience.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	2.4 (0.35)	2.1 (0.35)	2.1 (0.36)	NA (NA)	NA (NA)	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)	NA (NA)	NA (NA)	1.6 (0.41)
Month 6 (n=100, 100, 99,48, 48, NA)	3.6 (0.40)	3.3 (0.40)	3.2 (0.41)	3.0 (0.57)	3.3 (0.58)	NA (NA)
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 (0.60)	NA (NA)
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)	NA (NA)

39. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score
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. Higher scores represent better (less) fatigue impact on daily functioning.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	106	104	106	52	52	104
Month 1 (n=105, 103, 104, NA, NA, 103)	2.9 (0.47)	2.3 (0.48)	2.1 (0.49)	NA (NA)	NA (NA)	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)	NA (NA)	NA (NA)	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 (0.76)	NA (NA)
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 (0.80)	NA (NA)
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)	NA (NA)

40. Secondary Outcome

Title	Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)
Description	BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.
Time Frame	From Baseline to Months 1, 3, 6, 9, and 12

Outcome Measure Data

Analysis Population Description

All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score>0 cm and were evaluable. n=number of participants evaluable at each visit.

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.	Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.	Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.	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.	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	Participants received 2 placebo tablets twice daily and subcutaneous placebo every 2 weeks for 3 months.
Measure Participants	24	21	10	10	12	22
Month 1 (n=24, 21, 10, NA, NA, 22)	-1.23 (0.537)	-1.60 (0.508)	-2.30 (0.673)	NA (NA)	NA (NA)	-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)	NA (NA)	NA (NA)	-1.60 (0.624)
Month 6 (n=23, 21, 10, 9, 11, NA)	-2.24 (0.580)	-2.35 (0.560)	-3.58 (0.758)	-2.85 (0.778)	-3.31 (0.744)	NA (NA)
Month 9 (n=23, 20, 10, 9, 9, NA)	-2.06 (0.575)	-2.71 (0.558)	2.66 (0.747)	-3.00 (0.770)	-3.35 (0.761)	NA (NA)
Month 12 (n=23, 19, 10, 9, 9, NA)	-2.50 (0.594)	-3.30 (0.587)	-2.42 (0.779)	-2.31 (0.808)	-2.67 (0.806)	NA (NA)

Adverse Events

Arm/Group Title	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
Arm/Group Description	Participants received 1 tofacitinib 5-mg tablet twice daily, 1 placebo tablet twice daily, and subcutaneous placebo administered every 2 weeks.		Participants received 2 tofacitinib 5-mg tablets twice daily and subcutaneous placebo every 2 weeks.		Participants received 2 placebo tablets twice daily and adalimumab, 40 mg, administered subcutaneously every 2 weeks.		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.		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
All Cause Mortality
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/107 (7.5%)		4/104 (3.8%)		9/106 (8.5%)		3/52 (5.8%)		4/53 (7.5%)
Cardiac disorders
Atrial fibrillation	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Bradycardia	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Cardiac arrest	0/107 (0%)		0/104 (0%)		0/106 (0%)		1/52 (1.9%)		0/53 (0%)
Gastrointestinal disorders
Abdominal hernia	0/107 (0%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		1/53 (1.9%)
Chronic gastritis	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Diverticulum	0/107 (0%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		1/53 (1.9%)
Nausea	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Hepatobiliary disorders
Bile duct stone	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Infections and infestations
Appendicitis	0/107 (0%)		0/104 (0%)		0/106 (0%)		1/52 (1.9%)		0/53 (0%)
Herpes simplex	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Influenza	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Pneumonia	0/107 (0%)		0/104 (0%)		0/106 (0%)		1/52 (1.9%)		0/53 (0%)
Pyoderma streptococcal	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Injury, poisoning and procedural complications
Joint injury	1/107 (0.9%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Metabolism and nutrition disorders
Dehydration	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Musculoskeletal chest pain	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Psoriatic arthropathy	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Spondylolisthesis	0/107 (0%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		1/53 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Infected neoplasm	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Invasive ductal breast carcinoma	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Squamous cell carcinoma of the vulva	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Nervous system disorders
Migraine	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Transient ischaemic attack	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Renal and urinary disorders
Calculus urinary	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Nephropathy	0/107 (0%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		1/53 (1.9%)
Reproductive system and breast disorders
Cystocele	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Postmenopausal haemorrhage	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Rectocele	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Uterine polyp	0/107 (0%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		1/53 (1.9%)
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Bronchospasm	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Dyspnoea exertional	0/107 (0%)		0/104 (0%)		1/106 (0.9%)		0/52 (0%)		0/53 (0%)
Hypoxia	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Skin and subcutaneous tissue disorders
Angioedema	1/107 (0.9%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Dermal cyst	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Vascular disorders
Deep vein thrombosis	0/107 (0%)		0/104 (0%)		0/106 (0%)		0/52 (0%)		1/53 (1.9%)
Hypertension	0/107 (0%)		1/104 (1%)		0/106 (0%)		0/52 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	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
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/107 (29%)		43/104 (41.3%)		43/106 (40.6%)		15/52 (28.8%)		22/53 (41.5%)
Gastrointestinal disorders
Abdominal pain	1/107 (0.9%)		1/104 (1%)		2/106 (1.9%)		0/52 (0%)		3/53 (5.7%)
Nausea	3/107 (2.8%)		4/104 (3.8%)		6/106 (5.7%)		0/52 (0%)		1/53 (1.9%)
Infections and infestations
Nasopharyngitis	8/107 (7.5%)		12/104 (11.5%)		11/106 (10.4%)		4/52 (7.7%)		4/53 (7.5%)
Pharyngitis	5/107 (4.7%)		6/104 (5.8%)		7/106 (6.6%)		0/52 (0%)		3/53 (5.7%)
Upper respiratory tract infection	10/107 (9.3%)		11/104 (10.6%)		8/106 (7.5%)		5/52 (9.6%)		5/53 (9.4%)
Urinary tract infection	2/107 (1.9%)		4/104 (3.8%)		4/106 (3.8%)		1/52 (1.9%)		4/53 (7.5%)
Investigations
Alanine aminotransferase increased	3/107 (2.8%)		3/104 (2.9%)		8/106 (7.5%)		3/52 (5.8%)		1/53 (1.9%)
Aspartate aminotransferase increased	0/107 (0%)		1/104 (1%)		7/106 (6.6%)		1/52 (1.9%)		1/53 (1.9%)
Blood creatine phosphokinase increased	5/107 (4.7%)		5/104 (4.8%)		3/106 (2.8%)		1/52 (1.9%)		5/53 (9.4%)
Musculoskeletal and connective tissue disorders
Spinal pain	2/107 (1.9%)		1/104 (1%)		3/106 (2.8%)		3/52 (5.8%)		0/53 (0%)
Nervous system disorders
Headache	5/107 (4.7%)		11/104 (10.6%)		7/106 (6.6%)		2/52 (3.8%)		4/53 (7.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.