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Trial record 1 of 2 for:    a3921040
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Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

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ClinicalTrials.gov Identifier: NCT00687193
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : December 25, 2012
Last Update Posted : March 25, 2013
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 Arthritis, Rheumatoid
Interventions Drug: Placebo
Drug: CP-690,550
Enrollment 318
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Period Title: Overall Study
Started 53 53 52 53 54 52 [1]
Completed 51 49 50 49 52 48
Not Completed 2 4 2 4 2 4
Reason Not Completed
Adverse Event             0             1             2             3             0             2
Lack of Efficacy             1             1             0             0             0             2
Protocol Violation             1             2             0             1             2             0
[1]
One participant withdrew after randomization but prior to treatment.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo Total
Hide Arm/Group Description Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 53 53 52 53 54 52 317
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 52 participants 53 participants 54 participants 52 participants 317 participants
< 18 years 0 0 0 0 0 0 0
Between 18 and 44 years 8 11 13 9 12 14 67
Between 45 and 64 years 39 33 31 32 30 29 194
>= 65 years 6 9 8 12 12 9 56
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 52 participants 53 participants 54 participants 52 participants 317 participants
Female
42
  79.2%
47
  88.7%
44
  84.6%
44
  83.0%
44
  81.5%
43
  82.7%
264
  83.3%
Male
11
  20.8%
6
  11.3%
8
  15.4%
9
  17.0%
10
  18.5%
9
  17.3%
53
  16.7%
1.Primary Outcome
Title Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Hide Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant 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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Measure Type: Number
Unit of Measure: participants
20 36 38 45 49 8
2.Secondary Outcome
Title Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8
Hide Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant 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)at each visit.
Time Frame Week 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Measure Type: Number
Unit of Measure: participants
Week 2 (LOCF) 10 18 18 35 29 3
Week 4 (LOCF) 19 25 32 43 42 5
Week 8 (LOCF) 20 33 35 46 47 6
3.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant 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) at each visit.
Time Frame Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 52 53 52 53 54 52
Measure Type: Number
Unit of Measure: participants
Week 2 (LOCF) 1 5 6 17 12 0
Week 4 (LOCF) 5 12 15 29 25 1
Week 8 (LOCF) 6 20 23 33 36 1
Week 12 (LOCF) 7 14 24 37 39 4
4.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant 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) at each visit.
Time Frame Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Measure Type: Number
Unit of Measure: participants
Week 2 (LOCF) 0 0 1 5 4 0
Week 4 (LOCF) 1 2 9 14 9 0
Week 8 (LOCF) 3 7 13 20 22 1
Week 12 (LOCF) 4 7 14 26 28 1
5.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Hide Description ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant 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) at each visit.
Time Frame Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Measure Type: Number
Unit of Measure: participants
Week 2 (LOCF) 0 0 0 0 0 0
Week 4 (LOCF) 0 0 0 2 3 0
Week 8 (LOCF) 0 0 3 7 5 0
Week 12 (LOCF) 0 0 2 8 6 0
6.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]
Hide Description

The DAS28-3 (CRP) score is a measure of the perticipant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.

Change = value at observation minus value at baseline

Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Missing values were not imputed.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52) -0.56  (0.13) -1.03  (0.13) -1.01  (0.13) -1.65  (0.13) -1.63  (0.13) -0.20  (0.13)
Week 4 (n=52, 51, 51, 52, 52, 52) -0.82  (0.13) -1.29  (0.13) -1.65  (0.13) -2.33  (0.13) -2.14  (0.13) -0.23  (0.13)
Week 8 (n=51, 51, 51, 52, 52, 50) -0.98  (0.13) -1.63  (0.13) -1.95  (0.13) -2.62  (0.13) -2.55  (0.13) -0.15  (0.13)
Week 12 (n=51, 49, 50, 49, 52, 48) -1.09  (0.13) -1.71  (0.13) -2.02  (0.13) -2.81  (0.13) -2.70  (0.13) -0.12  (0.13)
7.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]
Hide Description

The DAS28-4 (ESR) score is a measure of the participant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.

Change = score at observation minus score at baseline.

Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n=52, 53, 50, 52, 54, 52) -0.52  (0.15) -0.93  (0.14) -1.00  (0.15) -1.66  (0.15) -1.58  (0.14) -0.25  (0.15)
Week 4 (n=52, 51, 51, 52, 52, 51) -0.79  (0.15) -1.32  (0.15) -1.69  (0.15) -2.42  (0.15) -2.31  (0.14) -0.23  (0.15)
Week 8 (n=51, 50, 51, 52, 52, 50) -1.03  (0.15) -1.68  (0.15) -2.05  (0.15) -2.92  (0.15) -2.87  (0.14) -0.12  (0.15)
Week 12 (n=51, 49, 50, 49, 52, 48) -1.10  (0.15) -1.74  (0.15) -2.20  (0.15) -3.05  (0.15) -2.98  (0.14) -0.10  (0.15)
8.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Hide Description

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Change = score at observation minus score at baseline.

Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52) -0.10  (0.06) -0.15  (0.06) -0.28  (0.06) -0.39  (0.06) -0.40  (0.06) 0.06  (0.06)
Week 4 (n=52, 51, 51, 52, 52, 52) -0.07  (0.06) -0.25  (0.06) -0.38  (0.06) -0.54  (0.06) -0.51  (0.06) 0.03  (0.06)
Week 8 (n=51, 50, 51, 52, 52, 50) -0.17  (0.06) -0.36  (0.06) -0.49  (0.06) -0.59  (0.06) -0.63  (0.06) 0.18  (0.06)
Week 12 (n=51, 49, 50, 49, 52, 48) -0.19  (0.06) -0.38  (0.06) -0.55  (0.06) -0.67  (0.06) -0.68  (0.06) 0.18  (0.06)
9.Secondary Outcome
Title Change From Baseline in Painful and Tender Joint Counts
Hide Description Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52) -4.14  (0.98) -5.13  (0.97) -5.29  (0.99) -8.48  (0.98) -7.73  (0.96) -2.03  (0.98)
Week 4 (n=52, 51, 51, 52, 52, 52) -5.92  (0.98) -6.95  (0.98) -8.41  (0.99) -11.35  (0.98) -10.41  (0.97) -1.12  (0.98)
Week 8 (n=51, 51, 51, 52, 52, 50) -6.27  (0.98) -8.80  (0.98) -9.65  (0.99) -12.89  (0.98) -12.16  (0.97) -0.49  (0.99)
Week 12 (n=51, 49, 50, 49, 52, 48) -7.05  (0.98) -10.01  (0.99) -10.08  (1.00) -13.67  (0.99) -12.81  (0.97) -0.67  (1.00)
10.Secondary Outcome
Title Change From Baseline in Swollen Joint Count (SJC)
Hide Description Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52) -3.19  (0.69) -3.85  (0.68) -2.58  (0.70) -6.93  (0.69) -5.95  (0.68) -1.58  (0.69)
Week 4 (n=52, 51, 51, 52, 52, 52) -4.57  (0.69) -6.10  (0.69) -6.15  (0.70) -8.85  (0.69) -8.15  (0.68) -1.87  (0.69)
Week 8 (n=51, 51, 51, 52, 52, 50) -5.25  (0.69) -7.08  (0.69) -7.15  (0.70) -10.04  (0.69) -10.52  (0.68) -1.70  (0.70)
Week 12 (n=51, 49, 50, 49, 52, 48) -5.76  (0.69) -7.94  (0.70) -7.75  (0.70) -10.44  (0.70) -10.73  (0.68) -1.29  (0.70)
11.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Pain
Hide Description

Change from Baseline in Patient's Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement.

Change = value at observation minus value at baseline.

Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52) -8.63  (2.94) -16.70  (2.94) -19.13  (3.01) -29.03  (2.97) -26.45  (2.92) -1.46  (2.98)
Week 4 (n=52, 51, 51, 52, 52, 52) -12.97  (2.96) -21.19  (2.98) -26.06  (3.01) -36.65  (2.97) -35.16  (2.95) -2.73  (2.98)
Week 8 (n=51, 50, 51, 52, 52, 50) -17.57  (2.97) -26.15  (2.99) -30.37  (3.01) -41.84  (2.97) -43.08  (2.95) 1.65  (3.01)
Week 12 (n=51, 49, 50, 49, 52, 48) -18.38  (2.97) -22.33  (3.00) -34.37  (3.02) -42.91  (3.01) -43.79  (2.95) -1.06  (3.03)
12.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Arthritis
Hide Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline.
Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52) -7.66  (2.96) -15.25  (2.97) -20.32  (3.04) -27.06  (2.99) -26.80  (2.94) -1.73  (3.00)
Week 4 (n=52, 51, 51, 52, 52, 52) -11.22  (2.98) -23.17  (3.00) -27.03  (3.04) -36.64  (2.99) -35.96  (2.97) -3.31  (3.00)
Week 8 (n=51, 50, 51, 52, 52, 50) -16.66  (2.99) -24.60  (3.01) -28.78  (3.04) -41.97  (2.99) -41.13  (2.97) 0.79  (3.03)
Week 12 (n=51, 49, 50, 49, 52, 48) -16.29  (2.99) -20.91  (3.03) -34.59  (3.05) -43.55  (3.03) -41.86  (2.97) -1.02  (3.05)
13.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Arthritis
Hide Description Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.
Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n=53, 53, 51, 52, 54, 52) -13.97  (2.64) -15.86  (2.63) -18.10  (2.70) -31.59  (2.66) -25.93  (2.61) -6.09  (2.66)
Week 4 (n=52, 51, 51, 52, 52, 52) -23.31  (2.65) -26.22  (2.67) -30.45  (2.70) -41.21  (2.66) -37.07  (2.64) -9.70  (2.66)
Week 8 (n=51, 51, 51, 52, 52, 50) -21.99  (2.66) -32.04  (2.67) -36.92  (2.70) -45.98  (2.66) -44.66  (2.64) -6.84  (2.69)
Week 12 (n=51, 49, 50, 49, 52, 48) -25.38  (2.66) -33.47  (2.69) -36.89  (2.71) -49.38  (2.70) -48.36  (2.64) -8.35  (2.72)
14.Secondary Outcome
Title Change From Baseline in C- Reactive Protein (CRP) (mg/L)
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.
Time Frame Baseline, Week 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
Week 2 (n=53, 53, 51, 52, 54, 52) -5.69  (2.24) -16.61  (2.24) -17.32  (2.29) -22.50  (2.26) -24.95  (2.22) 1.02  (2.26)
Week 4 (n=52, 51, 51, 52, 52, 52) -5.56  (2.25) -16.26  (2.27) -22.20  (2.29) -24.47  (2.26) -24.59  (2.25) 0.59  (2.26)
Week 8 (n=51, 51, 51, 52, 52, 50) -9.79  (2.27) -16.71  (2.27) -23.80  (2.29) -23.56  (2.26) -26.03  (2.25) 5.27  (2.29)
Week 12 (n=51, 49, 50, 49, 52, 48) -8.88  (2.27) -18.34  (2.30) -23.97  (2.30) -25.11  (2.30) -26.14  (2.25) 8.22  (2.32)
15.Secondary Outcome
Title Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)
Hide Description ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 53 53 52 53 54 52
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
498.47  (341.96) 1876.4  (341.96) 2573.0  (345.23) 3887.4  (341.96) 3628.9  (338.78) -2415  (345.23)
16.Secondary Outcome
Title Change From Baseline in Euro Quality of Life (EQ-5D)
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.10  (0.03) 0.21  (0.03) 0.28  (0.03) 0.33  (0.03) 0.33  (0.03) -0.04  (0.03)
17.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.62  (1.09) 6.23  (1.11) 5.83  (1.13) 9.59  (1.11) 8.61  (1.08) -2.53  (1.12)
18.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.15  (1.18) 4.42  (1.20) 6.17  (1.21) 8.91  (1.20) 7.77  (1.17) -0.72  (1.22)
19.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
5.94  (1.08) 7.81  (1.10) 9.74  (1.11) 12.58  (1.10) 13.90  (1.07) 0.27  (1.12)
20.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.12  (0.84) 4.76  (0.86) 5.37  (0.86) 7.57  (0.86) 7.61  (0.83) 0.16  (0.87)
21.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change =score at Week 12 minus score at baseline

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg BID CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.67  (0.74) 6.11  (0.76) 6.58  (0.77) 11.98  (0.77) 9.49  (0.74) 3.38  (0.79)
22.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.22  (1.21) 4.88  (1.24) 4.65  (1.24) 4.56  (1.24) 7.62  (1.20) -0.67  (1.25)
23.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.83  (1.41) 4.20  (1.44) 5.64  (1.44) 7.99  (1.44) 6.42  (1.40) -1.50  (1.47)
24.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.29  (1.29) 5.02  (1.32) 8.62  (1.32) 7.64  (1.32) 6.27  (1.28) 0.59  (1.34)
25.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.27  (0.86) 6.03  (0.88) 6.22  (0.89) 10.25  (0.88) 10.27  (0.85) -1.04  (0.89)
26.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)
Hide Description

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Change = score at Week 12 minus score at baseline.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description:
Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 51 49 50 49 52 48
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.00  (1.27) 3.99  (1.30) 7.09  (1.30) 6.15  (1.30) 5.52  (1.26) 0.15  (1.32)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Hide Arm/Group Description Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks. Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
All-Cause Mortality
CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   3/53 (5.66%)   2/52 (3.85%)   2/53 (3.77%)   1/54 (1.85%)   1/52 (1.92%) 
Gastrointestinal disorders             
Gastric ulcer perforation   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Infections and infestations             
Herpes zoster   0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  1/53 (1.89%)  0/54 (0.00%)  0/52 (0.00%) 
Herpes zoster oticus   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Injury, poisoning and procedural complications             
Fibula fracture   0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Spinal compression fracture   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Tendon rupture   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/54 (0.00%)  0/52 (0.00%) 
Tibia fracture   0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Investigations             
Alanine aminotransferase increased   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Aspartate aminotransferase increased   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Blood creatine phosphokinase increased   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Nervous system disorders             
Post herpetic neuralgia   0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Atelectasis   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  1/52 (1.92%) 
Vascular disorders             
Rheumatoid vasculitis   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg CP-690,550 15 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/53 (26.42%)   16/53 (30.19%)   19/52 (36.54%)   22/53 (41.51%)   22/54 (40.74%)   16/52 (30.77%) 
Gastrointestinal disorders             
Abdominal discomfort   2/53 (3.77%)  1/53 (1.89%)  0/52 (0.00%)  1/53 (1.89%)  0/54 (0.00%)  1/52 (1.92%) 
Constipation   1/53 (1.89%)  0/53 (0.00%)  1/52 (1.92%)  0/53 (0.00%)  3/54 (5.56%)  2/52 (3.85%) 
Dental caries   0/53 (0.00%)  0/53 (0.00%)  2/52 (3.85%)  1/53 (1.89%)  0/54 (0.00%)  1/52 (1.92%) 
Diarrhoea   1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  2/52 (3.85%) 
Gastritis   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  2/54 (3.70%)  0/52 (0.00%) 
Gingivitis   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  2/54 (3.70%)  1/52 (1.92%) 
Stomatitis   1/53 (1.89%)  1/53 (1.89%)  2/52 (3.85%)  1/53 (1.89%)  0/54 (0.00%)  1/52 (1.92%) 
Infections and infestations             
Bronchitis  1/53 (1.89%)  1/53 (1.89%)  0/52 (0.00%)  2/53 (3.77%)  0/54 (0.00%)  0/52 (0.00%) 
Herpes zoster   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  2/53 (3.77%)  1/54 (1.85%)  0/52 (0.00%) 
Nasopharyngitis   6/53 (11.32%)  4/53 (7.55%)  6/52 (11.54%)  3/53 (5.66%)  8/54 (14.81%)  6/52 (11.54%) 
Pharyngitis   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  3/53 (5.66%)  2/54 (3.70%)  1/52 (1.92%) 
Upper respiratory tract infection   0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%)  3/53 (5.66%)  0/54 (0.00%)  0/52 (0.00%) 
Injury, poisoning and procedural complications             
Contusion   2/53 (3.77%)  1/53 (1.89%)  0/52 (0.00%)  0/53 (0.00%)  1/54 (1.85%)  0/52 (0.00%) 
Fall   3/53 (5.66%)  0/53 (0.00%)  1/52 (1.92%)  1/53 (1.89%)  0/54 (0.00%)  0/52 (0.00%) 
Investigations             
Alanine aminotransferase increased   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  1/53 (1.89%)  1/54 (1.85%)  3/52 (5.77%) 
Aspartate aminotransferase increased   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  1/53 (1.89%)  0/54 (0.00%)  3/52 (5.77%) 
Blood cholesterol increased   0/53 (0.00%)  1/53 (1.89%)  1/52 (1.92%)  1/53 (1.89%)  2/54 (3.70%)  0/52 (0.00%) 
Low density lipoprotein increased   0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%)  1/53 (1.89%)  6/54 (11.11%)  0/52 (0.00%) 
Metabolism and nutrition disorders             
Hypercholesterolaemia   0/53 (0.00%)  2/53 (3.77%)  0/52 (0.00%)  3/53 (5.66%)  0/54 (0.00%)  0/52 (0.00%) 
Hyperlipidaemia   1/53 (1.89%)  0/53 (0.00%)  2/52 (3.85%)  6/53 (11.32%)  3/54 (5.56%)  0/52 (0.00%) 
Musculoskeletal and connective tissue disorders             
Rheumatoid arthritis   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  2/52 (3.85%) 
Nervous system disorders             
Headache   1/53 (1.89%)  3/53 (5.66%)  2/52 (3.85%)  1/53 (1.89%)  0/54 (0.00%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders             
Upper respiratory tract inflammation   0/53 (0.00%)  0/53 (0.00%)  0/52 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  2/52 (3.85%) 
Vascular disorders             
Hypertension   0/53 (0.00%)  0/53 (0.00%)  3/52 (5.77%)  1/53 (1.89%)  0/54 (0.00%)  0/52 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00687193    
Other Study ID Numbers: A3921040
First Submitted: May 22, 2008
First Posted: May 30, 2008
Results First Submitted: November 26, 2012
Results First Posted: December 25, 2012
Last Update Posted: March 25, 2013