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Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT01164579
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Tasocitinib plus Methotrexate
Drug: Tofacitinib plus placebo methotrexate
Drug: Placebo tofacitinib plus Methotrexate
Enrollment 109

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tofacitinib (CP-690,550) Plus Methotrexate (MTX) Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care. Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care. Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Period Title: Overall Study
Started 36 36 37
Completed 28 27 21
Not Completed 8 9 16
Reason Not Completed
Lack of Efficacy             0             0             6
Lost to Follow-up             1             1             0
Withdrawal by Subject             2             5             3
Protocol Violation             0             1             2
Adverse Event             4             2             5
Reason not specified             1             0             0
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate Total
Hide Arm/Group Description Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care. Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care. Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care. Total of all reporting groups
Overall Number of Baseline Participants 36 36 37 109
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): all participants who were randomized to study medication and received at least 1 dose of randomized study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 37 participants 109 participants
47.8  (12.3) 50.8  (12.8) 47.8  (11.6) 48.8  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 37 participants 109 participants
Female
31
  86.1%
30
  83.3%
29
  78.4%
90
  82.6%
Male
5
  13.9%
6
  16.7%
8
  21.6%
19
  17.4%
1.Primary Outcome
Title Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis
Hide Description Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Time Frame Month 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set: all randomized participants who received at least 1 dose of the randomized investigational drug and for whom a variable is nonmissing at both baseline and the specified timepoint.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 30 32 31
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.80  (0.41) -0.69  (0.40) -0.17  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2696
Comments 2-sided p-value; alpha equals (=) 0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least squares (LS) Mean
Estimated Value -0.63
Confidence Interval (2-Sided) 90%
-1.58 to 0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3561
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.52
Confidence Interval (2-Sided) 90%
-1.46 to 0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema
Hide Description Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
Time Frame Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 33 29 28
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.26  (0.41) -1.45  (0.42) 0.29  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0089
Comments 2-sided p-value; alpha= 0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.55
Confidence Interval (2-Sided) 90%
-2.52 to -0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments 2-sided p-value; alpha= 0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.74
Confidence Interval (2-Sided) 90%
-2.72 to -0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis
Hide Description Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Time Frame Months 1, 6, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 33 31 35
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Month 1 (n=28,31,35) -0.42  (0.42) -0.34  (0.40) -0.17  (0.38)
Month 6 (n=33,29,28) -1.22  (0.40) -1.29  (0.41) -0.28  (0.42)
Month 12 (n=29,26,21) -2.26  (0.41) -1.16  (0.43) -0.66  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6576
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.25
Confidence Interval (2-Sided) 90%
-1.19 to 0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7565
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.17
Confidence Interval (2-Sided) 90%
-1.09 to 0.74
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1038
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.94
Confidence Interval (2-Sided) 90%
-1.89 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0868
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.01
Confidence Interval (2-Sided) 90%
-1.98 to -0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.60
Confidence Interval (2-Sided) 90%
-2.62 to -0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4350
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.49
Confidence Interval (2-Sided) 90%
-1.53 to 0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.63
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP
Hide Description Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0–3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1–33% of bone edematous; 2: 34–66% of bone edematous; 3: 67–100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
Time Frame Months 1, 3, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 30 32 35
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Month 1 (n=28,31,35) -0.29  (0.43) 0.19  (0.41) 0.11  (0.39)
Month 3 (n=30,32,31) -0.77  (0.42) -0.86  (0.41) 0.47  (0.41)
Month 12 (n=29,26,21) -1.52  (0.42) -1.70  (0.43) 0.59  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4890
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.40
Confidence Interval (2-Sided) 90%
-1.36 to 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8817
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.08
Confidence Interval (2-Sided) 90%
-0.85 to 1.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0351
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.24
Confidence Interval (2-Sided) 90%
-2.21 to -0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0231
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.32
Confidence Interval (2-Sided) 90%
-2.28 to -0.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -2.10
Confidence Interval (2-Sided) 90%
-3.13 to -1.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -2.29
Confidence Interval (2-Sided) 90%
-3.32 to -1.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.63
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions
Hide Description Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.
Time Frame Months 1, 3, 6, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 33 32 35
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Month 1 (n=28,31,35) -0.12  (0.25) 0.27  (0.25) 0.27  (0.24)
Month 3 (n=30,32,31) -0.12  (0.25) 0.36  (0.24) 0.44  (0.25)
Month 6 (n=33,29,28) -0.06  (0.25) -0.02  (0.25) 0.65  (0.25)
Month 12 (n=29,26,21) -0.11  (0.25) -0.08  (0.25) 1.18  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2689
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.39
Confidence Interval (2-Sided) 90%
-0.96 to 0.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9935
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0
Confidence Interval (2-Sided) 90%
-0.58 to 0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1086
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.57
Confidence Interval (2-Sided) 90%
-1.15 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8092
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.08
Confidence Interval (2-Sided) 90%
-0.66 to 0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0463
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.71
Confidence Interval (2-Sided) 90%
-1.29 to -0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0624
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.67
Confidence Interval (2-Sided) 90%
-1.25 to -0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.29
Confidence Interval (2-Sided) 90%
-1.90 to -0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.26
Confidence Interval (2-Sided) 90%
-1.87 to -0.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Modified Total Sharp Score (mTSS) at Months 6 and 12
Hide Description Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 34 36 37
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Month 6 (n=29,27,28) 11.28  (0.50) 10.70  (0.51) 11.77  (0.52)
Month 12 (n=26,25,22) 11.70  (0.51) 10.69  (0.52) 12.21  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5019
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.48
Confidence Interval (2-Sided) 90%
-1.68 to 0.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1462
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.07
Confidence Interval (2-Sided) 90%
-2.28 to 0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.73
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4900
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.51
Confidence Interval (2-Sided) 90%
-1.74 to 0.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments [Not Specified]
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.51
Confidence Interval (2-Sided) 90%
-2.76 to -0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.75
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Months 6 and 12 in mTSS
Hide Description Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) + erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 29 27 28
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Month 6 (n=29,27,28) 0.44  (0.50) -0.14  (0.51) 0.93  (0.52)
Month 12 (n=26,25,22) 0.85  (0.51) -0.15  (0.52) 1.36  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5019
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.48
Confidence Interval (2-Sided) 90%
-1.68 to 0.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1462
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.07
Confidence Interval (2-Sided) 90%
-2.28 to 0.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.73
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4900
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.51
Confidence Interval (2-Sided) 90%
-1.74 to 0.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.51
Confidence Interval (2-Sided) 90%
-2.76 to -0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.75
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Joint Space Narrowing (JSN) Scores at Months 6 and 12
Hide Description JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 29 27 28
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Month 6 (n=29,27,28) 5.45  (0.34) 5.11  (0.35) 5.52  (0.36)
Month 12 (n=26,25,22) 5.59  (0.35) 5.05  (0.36) 5.88  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8959
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.07
Confidence Interval (2-Sided) 90%
-0.89 to 0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4193
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.41
Confidence Interval (2-Sided) 90%
-1.25 to 0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5764
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.29
Confidence Interval (2-Sided) 90%
-1.13 to 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1101
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.83
Confidence Interval (2-Sided) 90%
-1.69 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.52
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Months 6 and 12 in JSN Scores
Hide Description JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 29 27 28
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Month 6 (n=29,27,28) 0.29  (0.34) -0.06  (0.35) 0.35  (0.36)
Month 12 (n=26,25,22) 0.43  (0.35) -0.12  (0.36) 0.71  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8959
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.07
Confidence Interval (2-Sided) 90%
-0.89 to 0.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4193
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.41
Confidence Interval (2-Sided) 90%
-1.25 to 0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5764
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.29
Confidence Interval (2-Sided) 90%
-1.13 to 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1101
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.83
Confidence Interval (2-Sided) 90%
-1.69 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.52
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Erosion Scores at Months 6 and 12
Hide Description Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 29 27 28
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Month 6 (n=29,27,28) 5.84  (0.24) 5.59  (0.25) 6.26  (0.25)
Month 12 (n=26,25,22) 6.10  (0.25) 5.64  (0.26) 6.33  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2351
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.42
Confidence Interval (2-Sided) 90%
-1.00 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0631
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.67
Confidence Interval (2-Sided) 90%
-1.27 to -0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5369
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.23
Confidence Interval (2-Sided) 90%
-0.83 to 0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0620
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.69
Confidence Interval (2-Sided) 90%
-1.31 to -0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to Months 6 and 12 in Erosion Score
Hide Description Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 29 27 28
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Month 6 (n=29,27,28) 0.16  (0.24) -0.10  (0.25) 0.58  (0.25)
Month 12 (n=26,25,22) 0.42  (0.25) -0.05  (0.26) 0.65  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2351
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.42
Confidence Interval (2-Sided) 90%
-1.00 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0631
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.67
Confidence Interval (2-Sided) 90%
-1.27 to -0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5369
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.23
Confidence Interval (2-Sided) 90%
-0.83 to 0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0620
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.69
Confidence Interval (2-Sided) 90%
-1.31 to -0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response
Hide Description ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Time Frame Months 1, 2, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders. n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 35 36 37
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 (n=35,35,37) 42.86 57.14 29.73
Month 2 (n=35,36,37) 68.57 61.11 40.54
Month 3 (n=35,36,37) 77.14 61.11 48.65
Month 6 (n=35,36,37) 74.29 66.67 45.95
Month 9 (n=35,36,37) 71.43 58.33 43.24
Month 12 (n=35,36,37) 71.43 61.11 43.24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2430
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.12
Confidence Interval (2-Sided) 90%
-5.36 to 31.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0147
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.41
Confidence Interval (2-Sided) 90%
8.91 to 45.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0127
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.03
Confidence Interval (2-Sided) 90%
9.51 to 46.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.25
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0724
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.57
Confidence Interval (2-Sided) 90%
1.73 to 39.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.45
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.49
Confidence Interval (2-Sided) 90%
10.63 to 46.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.85
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2808
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.46
Confidence Interval (2-Sided) 90%
-6.54 to 31.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.55
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.18
Confidence Interval (2-Sided) 90%
9.81 to 46.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.16
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1921
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.09
Confidence Interval (2-Sided) 90%
-3.94 to 34.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.56
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0115
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.18
Confidence Interval (2-Sided) 90%
9.81 to 46.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.16
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1203
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.86
Confidence Interval (2-Sided) 90%
-1.05 to 36.79
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.50
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With an ACR 50% Improvement (ACR50) Response
Hide Description ACR50 response: ≥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.
Time Frame Months 1, 2, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS NRI; n=number of participants assess for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 35 36 37
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 (n=35,35,37) 22.86 22.86 2.70
Month 2 (n=35,36,37) 45.71 33.33 16.22
Month 3 (n=35,36,37) 48.57 50.00 24.32
Month 6 (n=35,36,37) 57.14 47.22 21.62
Month 9 (n=35,36,37) 57.14 44.44 29.73
Month 12 (n=35,36,37) 57.14 44.44 29.73
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.15
Confidence Interval (2-Sided) 90%
7.68 to 32.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.58
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.15
Confidence Interval (2-Sided) 90%
7.68 to 32.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.58
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0044
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 29.49
Confidence Interval (2-Sided) 90%
12.43 to 46.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.37
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0845
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.11
Confidence Interval (2-Sided) 90%
0.79 to 33.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.92
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0275
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 24.24
Confidence Interval (2-Sided) 90%
6.14 to 42.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.00
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0186
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.67
Confidence Interval (2-Sided) 90%
7.71 to 43.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.91
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 35.52
Confidence Interval (2-Sided) 90%
17.82 to 53.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.75
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0169
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.60
Confidence Interval (2-Sided) 90%
7.95 to 43.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.72
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0147
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.41
Confidence Interval (2-Sided) 90%
8.91 to 45.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.24
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1882
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.71
Confidence Interval (2-Sided) 90%
-3.68 to 33.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.18
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0147
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.41
Confidence Interval (2-Sided) 90%
8.91 to 45.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.24
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1882
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.71
Confidence Interval (2-Sided) 90%
-3.68 to 33.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.18
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With an ACR 70% Improvement (ACR70) Response
Hide Description ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.
Time Frame Months 1, 2, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS NRI; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 35 36 37
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 (n=35,35,37) 8.57 2.86 0.00
Month 2 (n=35,36,37) 31.43 22.22 5.41
Month 3 (n=35,36,37) 25.71 27.78 10.81
Month 6 (n=35,36,37) 34.29 30.56 21.62
Month 9 (n=35,36,37) 31.43 33.33 18.92
Month 12 (n=35,36,37) 22.86 33.33 21.62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0700
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.57
Confidence Interval (2-Sided) 90%
0.78 to 16.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.73
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3102
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.85
Confidence Interval (2-Sided) 90%
-1.77 to 7.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.81
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 26.02
Confidence Interval (2-Sided) 90%
11.73 to 40.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.68
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0324
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.81
Confidence Interval (2-Sided) 90%
3.88 to 29.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.86
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0969
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.90
Confidence Interval (2-Sided) 90%
0.13 to 29.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.97
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0606
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.96
Confidence Interval (2-Sided) 90%
2.09 to 31.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.04
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2276
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 12.66
Confidence Interval (2-Sided) 90%
-4.60 to 29.93
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.49
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3827
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.93
Confidence Interval (2-Sided) 90%
-7.90 to 25.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.23
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2177
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.50
Confidence Interval (2-Sided) 90%
-4.18 to 29.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.15
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1558
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.41
Confidence Interval (2-Sided) 90%
-2.29 to 31.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.15
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8997
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.23
Confidence Interval (2-Sided) 90%
-14.89 to 17.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.80
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2587
Comments [Not Specified]
Method Normal approximation to the binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.71
Confidence Interval (2-Sided) 90%
-5.34 to 28.76
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.36
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])
Hide Description DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (≤)3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<)2.6 = remission.
Time Frame Baseline and Months 1, 2, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assess for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 36 36 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=36,36,37) 5.14  (0.96) 5.48  (0.78) 5.36  (0.80)
Month 1 (n=33,35,37) 3.71  (1.15) 4.03  (0.91) 4.65  (1.07)
Month 2 (n=33,33,32) 2.99  (1.17) 3.52  (1.15) 4.21  (1.31)
Month 3 (n=33,33,31) 3.06  (1.02) 3.46  (1.09) 3.87  (1.43)
Month 6 (n=31,29,29) 2.74  (1.15) 2.75  (0.95) 3.92  (1.49)
Month 9 (n=30,28,24) 2.37  (0.98) 2.85  (0.90) 3.58  (1.63)
Month 12 (n=27,26,20) 2.49  (1.02) 2.68  (1.05) 3.58  (1.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 90%
-0.56 to 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-0.19 to 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.94
Confidence Interval (2-Sided) 90%
-1.38 to -0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 90%
-1.01 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.21
Confidence Interval (2-Sided) 90%
-1.73 to -0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.69
Confidence Interval (2-Sided) 90%
-1.20 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.81
Confidence Interval (2-Sided) 90%
-1.33 to -0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 90%
-0.94 to 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.18
Confidence Interval (2-Sided) 90%
-1.75 to -0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.18
Confidence Interval (2-Sided) 90%
-1.73 to -0.63
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.21
Confidence Interval (2-Sided) 90%
-1.81 to -0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.73
Confidence Interval (2-Sided) 90%
-1.33 to -0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.10
Confidence Interval (2-Sided) 90%
-1.69 to -0.51
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.90
Confidence Interval (2-Sided) 90%
-1.51 to -0.29
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in DAS28-3 (CRP)
Hide Description DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.
Time Frame Months 1, 2, 3, 6, 9, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tofacitinib (CP-690,550) Plus MTX Tofacitinib (CP-690,550) Methotrexate
Hide Arm/Group Description:
Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Overall Number of Participants Analyzed 33 35 37
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Month 1 (n=33,35,37) -1.61  (0.19) -1.40  (0.18) -0.73  (0.18)
Month 2 (n=33,33,32) -2.32  (0.19) -1.88  (0.19) -1.24  (0.19)
Month 3 (n=33,33,31) -2.25  (0.19) -1.96  (0.19) -1.57  (0.19)
Month 6 (n=31,29,29) -2.54  (0.19) -2.55  (0.20) -1.52  (0.19)
Month 9 (n=30,28,24) -2.92  (0.20) -2.43  (0.20) -1.76  (0.21)
Month 12 (n=27,26,20) -2.78  (0.20) -2.61  (0.20) -1.77  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.88
Confidence Interval (2-Sided) 90%
-1.31 to -0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.67
Confidence Interval (2-Sided) 90%
-1.10 to -0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.08
Confidence Interval (2-Sided) 90%
-1.52 to -0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0175
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.64
Confidence Interval (2-Sided) 90%
-1.08 to -0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0125
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.68
Confidence Interval (2-Sided) 90%
-1.13 to -0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1457
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.39
Confidence Interval (2-Sided) 90%
-0.84 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.02
Confidence Interval (2-Sided) 90%
-1.48 to -0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.03
Confidence Interval (2-Sided) 90%
-1.49 to -0.58
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.16
Confidence Interval (2-Sided) 90%
-1.63 to -0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550), Methotrexate
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0196
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.67
Confidence Interval (2-Sided) 90%
-1.14 to -0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Tofacitinib (CP-690,550) Plus MTX, Methotrexate
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments 2-sided p-value; alpha=0.10
Method mixed model repeated measures analysis
Comments [Not Specified]
Method