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Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

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ClinicalTrials.gov Identifier: NCT00603512
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : January 25, 2013
Last Update Posted : January 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 140
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 Placebo
Hide Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Period Title: Overall Study
Started 28 28 28 28 28
Treated 28 27 27 26 28
Completed 26 23 23 21 23
Not Completed 2 5 5 7 5
Reason Not Completed
Adverse Event             0             2             4             4             2
Lack of Efficacy             0             1             0             0             1
Other             2             1             0             1             1
Withdrawal by Subject             0             0             0             0             1
Randomized but not treated             0             1             1             2             0
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo Total
Hide Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 28 27 27 26 28 136
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 27 participants 27 participants 26 participants 28 participants 136 participants
52.0  (9.4) 53.3  (12.1) 50.0  (9.8) 50.6  (10.0) 50.6  (12.4) 51.3  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 27 participants 26 participants 28 participants 136 participants
Female
21
  75.0%
24
  88.9%
22
  81.5%
25
  96.2%
25
  89.3%
117
  86.0%
Male
7
  25.0%
3
  11.1%
5
  18.5%
1
   3.8%
3
  10.7%
19
  14.0%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Hide Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); 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
Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using 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 Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Measure Type: Number
Unit of Measure: Percentage of Participants
64.3 77.8 96.3 80.8 14.3
2.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Hide Description ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; 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 HAQ); and CRP.
Time Frame Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using 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 Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 28.57 14.81 29.63 38.46 3.57
Week 2 32.14 40.74 62.96 50.00 10.71
Week 4 50.00 55.56 88.89 76.92 10.71
Week 8 67.86 66.67 96.30 80.77 21.43
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 response: >= 50% improvement in tender or swollen joint counts 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 HAQ); and CRP.
Time Frame Week 1, 2, 4, 8, 12/End of Treatment (EOT)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using 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 Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 7.14 3.70 0.00 7.69 0.00
Week 2 7.14 7.41 25.93 26.92 0.00
Week 4 10.71 22.22 29.63 34.62 3.57
Week 8 28.57 29.63 70.37 50.00 7.14
Week 12 32.14 44.44 81.48 57.69 14.29
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 response: >= 70% improvement in tender or swollen joint counts 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 HAQ); and CRP.
Time Frame Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using 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 Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 0.00 0.00 0.00 3.85 0.00
Week 2 0.00 3.70 11.11 3.85 0.00
Week 4 3.57 7.41 14.81 7.69 0.00
Week 8 3.57 7.41 33.33 26.92 3.57
Week 12 7.14 14.81 33.33 34.62 3.57
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Hide Description ACR90 response: >= 90% improvement in tender or swollen joint counts 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 HAQ); and CRP.
Time Frame Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using 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 Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 0.00 0.00 0.00 0.00 0.00
Week 2 0.00 0.00 0.00 3.85 0.00
Week 4 0.00 0.00 3.70 0.00 0.00
Week 8 0.00 3.70 7.41 3.85 0.00
Week 12 0.00 11.11 3.70 11.54 0.00
6.Secondary Outcome
Title Tender Joint Count (TJC)
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.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: tender joints
Baseline (n=28,27,27,26,28) 16.36  (7.56) 16.22  (8.50) 17.81  (12.32) 15.42  (9.77) 16.36  (9.08)
Week 1 (n=28,26,27,26,28) 11.89  (7.06) 12.04  (10.95) 13.22  (14.04) 10.96  (11.89) 12.86  (9.03)
Week 2 (n=27,27,27,25,26) 11.63  (8.72) 9.63  (8.72) 9.52  (13.12) 8.20  (10.91) 11.62  (9.43)
Week 4 (n=27,26,27,24,25) 10.04  (7.64) 7.00  (7.61) 8.22  (10.48) 5.58  (6.35) 13.76  (11.30)
Week 8 (n=26,25,26,23,24) 6.73  (6.80) 5.40  (7.64) 5.15  (6.49) 3.35  (4.71) 11.04  (8.38)
Week 12 (n=26,24,24,21,24) 5.92  (6.73) 6.38  (9.60) 3.63  (4.39) 2.71  (4.33) 9.96  (7.85)
7.Secondary Outcome
Title Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT
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.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: tender joints
Week 1 (n=28,26,27,26,28) -4.46  (4.80) -4.19  (6.92) -4.59  (5.76) -4.46  (7.61) -3.50  (5.68)
Week 2 (n=27,27,27,25,26) -4.70  (7.37) -6.59  (7.31) -8.30  (6.36) -6.88  (6.09) -4.54  (5.48)
Week 4 (n=27,26,27,24,25) -6.30  (8.78) -9.00  (8.94) -9.59  (7.00) -9.88  (7.50) -2.28  (8.38)
Week 8 (n=26,25,26,23,24) -9.42  (8.90) -10.84  (9.00) -12.88  (10.77) -12.09  (8.23) -4.04  (7.17)
Week 12 (n=26,24,24,21,24) -10.23  (8.84) -9.96  (10.79) -14.42  (10.43) -12.71  (8.01) -5.13  (7.27)
8.Secondary Outcome
Title 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.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: swollen joints
Baseline (n=28,27,27,26,28) 13.18  (5.63) 15.11  (7.92) 15.59  (12.41) 15.12  (9.96) 13.82  (6.27)
Week 1 (n=28,26,27,26,28) 10.07  (5.87) 12.62  (9.21) 12.70  (12.66) 9.73  (10.98) 13.18  (7.45)
Week 2 (n=27,27,27,25,26) 8.26  (4.81) 9.67  (6.23) 9.41  (11.52) 8.04  (11.36) 12.04  (6.95)
Week 4 (n=27,26,27,24,25) 7.85  (6.00) 8.19  (6.50) 7.41  (9.28) 6.63  (7.83) 11.80  (7.88)
Week 8 (n=26,25,26,23,24) 5.92  (4.86) 6.12  (5.40) 4.62  (4.99) 5.17  (6.31) 11.08  (8.10)
Week 12 (n=26,24,24,21,24) 5.19  (5.87) 5.29  (5.43) 3.83  (4.24) 4.05  (5.98) 11.13  (7.12)
9.Secondary Outcome
Title Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT
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.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: swollen joints
Week 1 (n=28,26,27,26,28) -3.11  (5.26) -2.54  (6.11) -2.89  (2.81) -5.38  (5.08) -0.64  (3.71)
Week 2 (n=27,27,27,25,26) -4.74  (5.45) -5.44  (6.57) -6.19  (5.02) -6.84  (4.87) -1.69  (3.48)
Week 4 (n=27,26,27,24,25) -5.15  (7.25) -6.69  (7.07) -8.19  (5.94) -8.50  (5.16) -1.68  (4.59)
Week 8 (n=26,25,26,23,24) -6.92  (6.56) -8.96  (8.25) -11.35  (8.91) -10.09  (6.08) -2.08  (6.55)
Week 12 (n=26,24,24,21,24) -7.65  (7.53) -9.71  (8.16) -12.58  (10.06) -11.71  (6.68) -2.04  (5.77)
10.Secondary Outcome
Title Patient Assessment of Arthritis Pain
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 = no pain and 100 = most severe pain.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=28,26,27,26,28) 54.18  (23.48) 57.59  (20.18) 53.22  (25.94) 52.19  (24.97) 53.32  (23.63)
Week 1 (n=28,26,27,26,28) 45.36  (20.32) 43.50  (20.69) 40.19  (24.03) 37.08  (23.38) 49.36  (24.42)
Week 2 (n=27,27,27,25,26) 45.11  (20.11) 40.52  (24.32) 33.19  (24.63) 31.40  (20.92) 48.58  (25.56)
Week 4 (n=27,26,27,25,26) 42.44  (20.98) 34.88  (22.45) 25.19  (20.67) 30.46  (23.60) 49.72  (24.46)
Week 8 (n=26,25,27,23,24) 32.65  (17.84) 30.04  (23.37) 22.59  (21.45) 19.43  (18.64) 48.88  (23.01)
Week 12 (n=26,24,24,21,24) 32.19  (17.69) 27.17  (21.40) 17.58  (17.27) 16.90  (20.29) 44.96  (25.41)
11.Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mm
Week 1 (n=28,26,27,26,28) -8.82  (18.21) -14.35  (16.99) -13.04  (18.78) -15.12  (19.89) -3.96  (14.90)
Week 2 n=27,27,27,25,26) -10.41  (20.16) -17.07  (25.47) -20.04  (22.04) -22.44  (27.77) -3.69  (10.60)
Week 4 (n=27,26,27,24,25) -13.07  (23.22) -23.35  (22.89) -28.04  (23.74) -24.29  (26.28) -1.00  (14.27)
Week 8 (n=26,25,27,23,24) -22.54  (26.84) -28.92  (23.46) -30.63  (25.40) -34.26  (26.19) -2.04  (22.66)
Week 12 (n=26,24,24,21,24) -23.00  (25.13) -32.50  (22.75) -31.38  (22.67) -38.43  (28.38) -5.96  (22.61)
12.Secondary Outcome
Title Patient Global Assessment (PtGA) 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 VAS, where 0 = very well and 100 = very poorly.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=28,27,27,26,28) 58.00  (18.27) 60.26  (21.79) 58.67  (23.63) 52.04  (26.27) 53.50  (24.04)
Week 1 (n=28,26,27,26,28) 45.89  (21.08) 44.27  (19.25) 42.56  (24.48) 34.73  (21.41) 46.54  (23.49)
Week 2 (n=27,27,27,25,26) 46.07  (22.39) 42.63  (23.82) 33.78  (25.04) 30.44  (20.57) 48.42  (25.65)
Week 4 (n=27,26,27,24,25) 44.59  (22.89) 34.23  (21.81) 28.93  (21.61) 30.04  (22.62) 49.16  (25.09)
Week 8 (n=26,25,27,23,24) 35.12  (17.80) 30.68  (24.36) 21.81  (22.22) 20.39  (20.85) 49.17  (22.00)
Week 12 (n=26,24,24,21,24) 31.42  (17.08) 24.21  (19.82) 17.13  (16.00) 16.48  (18.62) 43.75  (24.60)
13.Secondary Outcome
Title Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT
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 VAS, where 0 = very well and 100 = very poorly.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mm
Week 1 (n=28,26,27,26,28) -12.11  (17.07) -16.92  (17.48) -16.11  (20.72) -17.31  (20.45) -6.96  (15.78)
Week 2 (n=27,27,27,25,26) -12.19  (18.44) -17.63  (25.30) -24.89  (21.03) -23.40  (28.28) -3.69  (12.29)
Week 4 (n=27,26,27,24,25) -13.67  (20.21) -27.50  (21.80) -29.74  (21.90) -24.50  (26.24) -1.40  (14.92)
Week 8 (n=26,25,27,23,24) -22.85  (25.79) -32.04  (22.17) -36.85  (22.07) -33.09  (27.70) -1.46  (23.75)
Week 12 (n=26,24,24,21,24) -26.54  (24.18) -38.00  (21.09) -37.46  (19.91) -38.33  (29.46) -6.88  (21.45)
14.Secondary Outcome
Title Physician Global Assessment (PGA) of Arthritis
Hide Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=28,27,27,26,28) 66.00  (16.32) 61.44  (19.18) 59.37  (17.67) 59.04  (18.00) 59.39  (19.88)
Week 1 (n=28,26,27,26,28) 49.96  (17.44) 47.96  (19.95) 45.26  (21.43) 36.12  (19.45) 50.64  (22.39)
Week 2 (n=27,27,27,25,26) 44.04  (18.74) 42.52  (23.78) 34.59  (22.64) 28.84  (18.90) 44.62  (22.26)
Week 4 (n=27,26,27,24,25) 41.30  (20.94) 33.04  (18.66) 24.67  (17.67) 23.92  (16.60) 47.96  (23.20)
Week 8 (n=26,25,26,23,24) 29.65  (15.94) 26.08  (18.70) 17.46  (14.83) 16.57  (13.62) 40.21  (21.40)
Week 12 (n=26,24,24,21,24) 26.31  (20.39) 23.38  (17.00) 13.71  (10.58) 14.86  (12.28) 40.92  (21.69)
15.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT
Hide Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mm
Week 1 (n=28,26,27,26,28) -16.04  (15.29) -14.12  (13.11) -14.11  (12.67) -22.92  (21.00) -8.75  (15.39)
Week 2 (n=27,27,27,25,26) -22.33  (18.70) -18.93  (18.12) -24.78  (16.65) -30.16  (20.74) -13.69  (18.05)
Week 4 (n=27,26,27,24,25) -25.07  (25.23) -28.23  (17.91) -34.70  (18.49) -34.83  (19.77) -9.36  (20.67)
Week 8 (n=26,25,26,23,24) -35.88  (23.06) -35.72  (15.68) -41.46  (17.19) -42.17  (19.26) -16.63  (23.24)
Week 12 (n=26,24,24,21,24) -39.23  (27.72) -36.92  (17.53) -44.71  (15.94) -45.05  (20.37) -15.92  (24.95)
16.Secondary Outcome
Title 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.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=28,27,27,26,28) 1.14  (0.74) 1.29  (0.64) 1.17  (0.60) 1.16  (0.58) 1.25  (0.70)
Week 1 (n=28,26,27,26,28) 1.05  (0.75) 1.23  (0.66) 1.05  (0.54) 0.85  (0.54) 1.25  (0.74)
Week 2 (n=27,27,27,25,26) 1.04  (0.72) 1.12  (0.66) 0.88  (0.56) 0.79  (0.50) 1.18  (0.76)
Week 4 (n=27,26,27,24,25) 0.94  (0.74) 1.04  (0.75) 0.79  (0.55) 0.77  (0.58) 1.07  (0.70)
Week 8 (n=26,25,27,23,24) 0.80  (0.69) 0.96  (0.78) 0.72  (0.54) 0.64  (0.53) 1.21  (0.80)
Week 12 (n=26,24,24,21,24) 0.78  (0.70) 0.81  (0.73) 0.56  (0.41) 0.59  (0.54) 1.13  (0.79)
17.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT
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.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (n=28,26,27,26,28) -0.08  (0.29) -0.11  (0.37) -0.12  (0.18) -0.31  (0.39) -0.00  (0.19)
Week 2 (n=27,27,27,25,26) -0.13  (0.35) -0.17  (0.39) -0.29  (0.32) -0.39  (0.38) -0.02  (0.26)
Week 4 (n=27,26,27,24,25) -0.22  (0.48) -0.25  (0.47) -0.38  (0.30) -0.43  (0.42) -0.10  (0.26)
Week 8 (n=26,25,27,23,24) -0.36  (0.58) -0.32  (0.49) -0.45  (0.31) -0.52  (0.44) 0.03  (0.40)
Week 12 (n=26,24,24,21,24) -0.38  (0.55) -0.41  (0.46) -0.49  (0.35) -0.57  (0.46) -0.05  (0.43)
18.Secondary Outcome
Title C-Reactive Protein (CRP)
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. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline (n=28,27,27,26,28) 26.71  (31.02) 27.63  (26.00) 16.59  (16.15) 20.03  (21.22) 22.25  (25.05)
Week 1 (n=28,26,27,26,28) 15.45  (21.23) 13.22  (16.89) 4.52  (6.49) 3.29  (4.91) 20.63  (22.24)
Week 2 (n=27,27,27,25,26) 15.79  (20.73) 10.34  (14.03) 3.16  (5.37) 2.15  (3.43) 18.12  (21.97)
Week 4 (n=27,26,27,24,25) 14.33  (21.04) 9.59  (14.22) 2.35  (3.36) 2.40  (5.13) 17.24  (18.87)
Week 8 (n=26,25,27,23,24) 13.82  (22.16) 4.19  (5.31) 4.18  (12.36) 10.72  (23.02) 15.29  (16.50)
Week 12 (n=26,24,24,21,24) 12.04  (21.23) 8.78  (17.44) 2.98  (8.72) 7.00  (16.05) 17.37  (25.30)
19.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT
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. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 1 (n=28,26,27,26,28) -11.26  (14.29) -15.37  (20.41) -12.07  (11.50) -16.75  (19.28) -1.62  (11.47)
Week 2 (n=27,27,27,25,26) -11.83  (16.03) -17.29  (20.63) -13.43  (12.71) -18.54  (21.03) -2.38  (16.85)
Week 4 (n=27,26,27,24,25) -13.29  (20.00) -18.35  (22.09) -14.24  (13.90) -17.31  (21.16) -3.26  (16.48)
Week 8 (n=26,25,27,23,24) -14.66  (22.72) -22.90  (24.20) -12.41  (16.40) -9.19  (23.29) -5.83  (16.73)
Week 12 (n=26,24,24,21,24) -16.43  (27.15) -17.89  (28.20) -10.49  (14.72) -14.10  (22.34) -3.75  (19.97)
20.Secondary Outcome
Title Numeric Index of American College of Rheumatology Response (ACR-n)
Hide Description ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the 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.
Time Frame Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using 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 Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 4.80  (32.73) 6.06  (20.00) 10.60  (19.13) 10.73  (42.87) -11.08  (21.61)
Week 2 8.74  (28.66) 17.43  (25.30) 30.61  (26.21) 25.15  (28.64) -8.84  (26.69)
Week 4 14.67  (38.45) 23.83  (32.99) 40.88  (26.07) 37.08  (25.42) -23.54  (51.98)
Week 8 30.40  (33.10) 31.64  (33.87) 56.76  (24.53) 45.62  (29.46) -18.74  (62.37)
Week 12 30.26  (35.83) 34.64  (48.37) 60.16  (24.26) 52.08  (32.22) -11.19  (38.76)
21.Secondary Outcome
Title Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
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 up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using 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 Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale*weeks
1708.31  (2458.38) 2096.79  (2355.96) 3685.71  (1721.44) 3124.40  (2011.19) -1346.24  (2995.11)
22.Secondary Outcome
Title Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Hide Description DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint 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, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=28,27,27,26,28) 5.03  (0.68) 5.13  (0.94) 5.00  (0.96) 4.94  (1.01) 4.90  (0.87)
Week 1 (n=28,26,27,26,28) 4.30  (0.86) 4.30  (1.10) 4.09  (1.28) 3.74  (0.93) 4.61  (1.08)
Week 2 (n=27,27,27,25,26) 4.23  (0.95) 3.95  (1.18) 3.46  (1.25) 3.25  (1.01) 4.43  (1.11)
Week 4 (n=27,26,27,24,25) 3.96  (1.13) 3.63  (1.05) 3.21  (1.27) 2.80  (0.94) 4.56  (1.15)
Week 8 (n=26,25,26,23,24) 3.43  (1.03) 3.03  (1.10) 2.77  (0.97) 2.52  (0.96) 4.31  (1.21)
Week 12 (n=26,24,24,21,24) 3.21  (1.05) 3.14  (1.27) 2.55  (0.90) 2.14  (0.61) 4.15  (1.36)
23.Secondary Outcome
Title Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Hide Description DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.
Time Frame Baseline, Week 1, 2, 4, 8, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=28,27,27,26,28) 6.11  (0.79) 6.06  (1.04) 6.02  (1.03) 5.86  (0.95) 5.86  (0.96)
Week 1 (n=28,26,27,26,28) 5.42  (0.98) 5.33  (1.22) 5.09  (1.34) 4.88  (1.08) 5.46  (1.11)
Week 2 (n=27,27,27,25,26) 5.29  (1.07) 5.03  (1.36) 4.48  (1.37) 4.28  (1.04) 5.34  (1.24)
Week 4 (n=27,26,27,24,25) 5.00  (1.04) 4.54  (1.29) 4.03  (1.43) 3.72  (1.13) 5.49  (1.29)
Week 8 (n=26,25,26,23,24) 4.37  (1.05) 4.00  (1.34) 3.49  (1.21) 3.13  (1.12) 5.22  (1.42)
Week 12 (n=26,24,24,21,24) 4.07  (0.99) 3.90  (1.36) 3.13  (0.99) 2.83  (0.99) 5.07  (1.47)
24.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36)
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).
Time Frame Baseline, Week 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline:Physical functioning (n=28,27,27,26,28) 37.87  (9.10) 37.94  (9.37) 38.87  (10.41) 40.93  (9.47) 38.69  (9.80)
Baseline:Role Physical (n=28,27,27,26,28) 39.27  (11.83) 41.43  (13.22) 44.25  (10.25) 45.64  (13.33) 42.77  (11.69)
Baseline:Bodily Pain (n=28,27,27,26,28) 37.27  (7.89) 36.89  (7.53) 38.59  (8.44) 40.58  (7.00) 36.81  (9.61)
Baseline:General Health (n=28,27,27,26,28) 37.54  (6.14) 37.56  (7.53) 37.57  (10.16) 38.87  (8.25) 37.42  (7.00)
Baseline:Vitality (n=28,27,27,26,28) 45.07  (11.58) 46.31  (10.49) 46.19  (11.13) 46.69  (9.86) 46.96  (9.58)
Baseline:Social Functioning (n=28,27,27,26,28) 46.72  (13.5) 42.71  (13.21) 45.54  (10.47) 46.78  (11.82) 45.16  (12.74)
Baseline:Role-Emotional (n=28,27,27,26,28) 40.61  (13.00) 41.05  (13.47) 45.37  (10.33) 45.11  (14.93) 44.91  (13.13)
Baseline:Mental Health (n=28,27,27,26,28) 43.07  (10.15) 44.27  (9.12) 43.65  (10.11) 46.97  (10.98) 45.08  (11.81)
Baseline:Physical Component (n=28,27,27,26,28) 37.16  (7.71) 37.54  (7.92) 38.75  (8.59) 40.39  (7.02) 37.35  (8.56)
Baseline:Mental Component (n=28,27,27,26,28) 46.06  (12.16) 45.81  (11.86) 47.38  (9.60) 48.48  (11.72) 48.36  (12.08)
Week 12:Physical functioning (n=26,24,24,21,24) 42.71  (10.07) 43.27  (9.69) 46.42  (9.00) 47.51  (9.86) 40.72  (9.40)
Week 12:Role Physical (n=26,24,24,21,24) 44.61  (10.39) 46.96  (10.60) 50.73  (7.19) 50.32  (9.37) 44.81  (10.21)
Week 12:Bodily Pain (n=26,24,24,21,24) 42.81  (7.05) 44.58  (8.93) 48.70  (7.20) 49.94  (8.45) 39.77  (7.98)
Week 12:General Health (n=26,24,24,21,24) 42.08  (7.07) 43.14  (8.63) 45.03  (7.76) 45.19  (8.06) 37.78  (8.03)
Week 12:Vitality (n=26,24,24,21,24) 50.53  (10.27) 49.88  (11.52) 53.65  (11.24) 52.24  (11.53) 48.71  (11.20)
Week 12:Social Functioning (n=26,24,24,21,24) 48.46  (10.37) 46.62  (12.49) 51.85  (7.36) 52.43  (8.20) 47.99  (12.12)
Week 12:Role-Emotional (n=26,24,24,21,24) 47.51  (8.64) 46.16  (12.08) 47.78  (10.12) 48.47  (9.83) 44.70  (12.15)
Week 12:Mental Health (n=26,24,24,21,24) 50.22  (7.96) 47.90  (11.87) 51.53  (7.33) 49.07  (12.51) 46.25  (13.81)
Week 12:Physical Component (n=26,24,24,21,24) 41.21  (9.42) 43.87  (7.75) 47.27  (6.61) 48.39  (7.18) 39.77  (6.59)
Week 12:Mental Component (n=26,24,24,21,24) 51.90  (8.68) 48.93  (13.44) 52.07  (8.99) 50.68  (10.10) 49.00  (13.09)
25.Secondary Outcome
Title Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
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, selfcare, 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.
Time Frame Baseline, Week 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=28,27,27,26,28) 0.55  (0.26) 0.45  (0.29) 0.58  (0.24) 0.55  (0.32) 0.51  (0.33)
Week 12 (n=26,24,24,21,24) 0.65  (0.23) 0.70  (0.27) 0.79  (0.13) 0.78  (0.28) 0.59  (0.27)
26.Secondary Outcome
Title Medical Outcome Study- Sleep Scale (MOS-SS)
Hide Description Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.
Time Frame Baseline, Week 2, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: SPS (n=28,27,27,26,28) 27.38  (11.42) 27.41  (14.36) 29.38  (17.54) 30.51  (18.78) 23.93  (12.57)
Baseline: OSP (n=28,27,27,26,28) 28.00  (10.53) 27.55  (12.40) 31.07  (17.38) 31.28  (18.60) 25.95  (12.89)
Baseline: Ade (n=28,27,27,26,28) 52.86  (24.47) 52.96  (24.93) 49.63  (27.80) 51.54  (26.64) 58.57  (27.98)
Baseline: ASOB (n=28,27,27,26,28) 3.57  (9.51) 4.44  (10.13) 8.15  (22.37) 10.00  (14.14) 3.57  (7.80)
Baseline: SD (n=28,27,27,26,28) 24.06  (17.70) 23.84  (21.10) 25.28  (20.95) 25.77  (21.45) 21.43  (16.66)
Baseline: Opt (n=28,27,27,26,28) 0.61  (0.50) 0.30  (0.47) 0.41  (0.50) 0.42  (0.50) 0.39  (0.50)
Baseline: Qua (n=28,27,27,26,28) 6.61  (1.10) 6.37  (1.45) 6.30  (0.87) 6.38  (1.27) 6.43  (1.29)
Baseline: Sno (n=28,27,27,26,28) 25.00  (27.01) 32.59  (34.26) 31.85  (31.99) 23.08  (29.77) 31.43  (29.53)
Baseline: Som (n=28,27,27,26,28) 29.05  (19.13) 28.64  (17.81) 34.57  (25.22) 32.05  (22.86) 31.90  (19.49)
Week 2: SPS (n=27,27,27,25,26) 27.04  (11.52) 25.19  (12.55) 22.10  (16.28) 27.87  (19.41) 26.67  (16.49)
Week 2: OSP (n=28,27,27,26,28) 27.61  (10.05) 25.62  (12.35) 22.78  (15.29) 27.47  (18.67) 27.74  (15.79)
Week 2: Ade (n=28,27,27,26,28) 53.33  (23.86) 54.81  (22.42) 64.07  (27.49) 51.20  (29.48) 55.38  (25.33)
Week 2: ASOB (n=28,27,27,26,28) 5.93  (16.47) 4.44  (8.47) 8.15  (20.95) 7.20  (12.75) 4.62  (11.74)
Week 2: SD (n=28,27,27,26,28) 22.31  (14.11) 19.68  (19.19) 17.92  (14.88) 21.40  (21.39) 21.44  (18.22)
Week 2: Opt (n=28,27,27,26,28) 0.63  (0.49) 0.44  (0.51) 0.56  (0.51) 0.52  (0.51) 0.38  (0.50)
Week 2: Qua (n=28,27,27,26,28) 6.70  (0.82) 6.52  (1.16) 6.70  (1.14) 6.84  (1.25) 6.50  (1.24)
Week 2: Sno (n=28,27,27,26,28) 25.19  (26.94) 25.19  (22.60) 23.70  (29.89) 17.60  (24.71) 30.00  (34.06)
Week 2: Som (n=28,27,27,26,28) 30.37  (18.05) 29.14  (19.93) 27.90  (23.46) 26.13  (23.88) 35.64  (20.65)
Week 12: SPS (n=26,24,24,21,24) 24.49  (10.83) 24.17  (14.22) 23.89  (11.78) 25.56  (14.47) 28.75  (14.24)
Week 12: OSP (n=26,24,24,21,24) 25.19  (10.33) 24.19  (13.39) 23.08  (10.74) 24.52  (14.29) 29.56  (13.10)
Week 12: Ade (n=26,24,24,21,24) 60.00  (22.63) 58.75  (26.75) 51.67  (24.08) 53.33  (23.94) 54.17  (19.54)
Week 12: ASOB (n=26,24,24,21,24) 6.92  (13.79) 9.17  (14.42) 5.00  (10.63) 3.81  (8.05) 10.00  (20.43)
Week 12: SD (n=26,24,24,21,24) 20.34  (13.42) 19.22  (18.43) 14.43  (10.52) 18.99  (19.05) 21.09  (16.56)
Week 12: Opt (n=26,24,24,21,24) 0.54  (0.51) 0.38  (0.49) 0.38  (0.49) 0.48  (0.51) 0.46  (0.51)
Week 12: Qua (n=26,24,24,21,24) 6.35  (1.20) 6.54  (1.28) 6.38  (0.97) 6.71  (1.38) 6.54  (1.53)
Week 12: Sno (n=26,24,24,21,24) 24.62  (22.13) 21.67  (22.78) 29.17  (32.83) 13.33  (20.33) 33.33  (31.02)
Week 12: Som (n=26,24,24,21,24) 30.26  (18.59) 25.28  (20.99) 25.28  (16.33) 24.13  (23.24) 40.28  (19.51)
27.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
Hide Description FACIT-F is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame Baseline, Week 2, 12/EOT
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP-690,550 1 mg CP-690,550 3 mg CP-690,550 5 mg CP-690,550 10 mg Placebo
Hide Arm/Group Description:
CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
CP-690,550 3 mg tablet orally twice daily for 12 weeks.
CP-690,550 5 mg tablet orally twice daily for 12 weeks.
CP-690,550 10 mg tablet orally twice daily for 12 weeks.
Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 28 27 27 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=28,27,27,26,28) 34.25  (10.45) 33.37  (11.03) 34.48  (9.99) 36.85  (9.43) 37.07  (9.87)
Week 2 (n=27,27,27,25,26) 36.78  (8.64) 36.48  (9.72) 39.30  (10.56) 40.80  (6.87) 37.38  (10.31)
Week 12 (n=26,24,24,21,24) 39.35  (7.47) 37.96  (9.95) 42.79  (8.47) 40.76  (10.65) 36.46  (9.93)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a 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 Placebo
Hide Arm/Group Description CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks. CP-690,550 3 mg tablet orally twice daily for 12 weeks. CP-690,550 5 mg tablet orally twice daily for 12 weeks. CP-690,550 10 mg tablet orally twice daily for 12 weeks. 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 Placebo
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 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/28 (3.57%)   1/27 (3.70%)   1/27 (3.70%)   2/26 (7.69%)   0/28 (0.00%) 
Cardiac disorders           
Cardiac failure * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Injury, poisoning and procedural complications           
Femur fracture * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders           
Foot deformity * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Osteoarthritis * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v11.1
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 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/28 (50.00%)   16/27 (59.26%)   19/27 (70.37%)   19/26 (73.08%)   11/28 (39.29%) 
Eye disorders           
Cataract * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Conjunctivitis * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Dry eye * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Eyelid pain * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Vision blurred * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  1/28 (3.57%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Constipation * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Diarrhoea * 1  1/28 (3.57%)  0/27 (0.00%)  1/27 (3.70%)  1/26 (3.85%)  0/28 (0.00%) 
Gastric mucosal lesion * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Gastritis * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Gastrooesophageal reflux disease * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Haematochezia * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Nausea * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Paraesthesia oral * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Stomach discomfort * 1  0/28 (0.00%)  0/27 (0.00%)  3/27 (11.11%)  0/26 (0.00%)  0/28 (0.00%) 
Stomatitis * 1  2/28 (7.14%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
General disorders           
Chest pain * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Fatigue * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Malaise * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Pyrexia * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Infections and infestations           
Acute tonsillitis * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Bronchitis * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Cystitis * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  1/26 (3.85%)  0/28 (0.00%) 
Dermatitis infected * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Enterocolitis viral * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Erysipelas * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Gastroenteritis * 1  0/28 (0.00%)  2/27 (7.41%)  0/27 (0.00%)  1/26 (3.85%)  1/28 (3.57%) 
Gastroenteritis viral * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Localised infection * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Nasopharyngitis * 1  3/28 (10.71%)  1/27 (3.70%)  1/27 (3.70%)  4/26 (15.38%)  4/28 (14.29%) 
Paronychia * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Pharyngitis * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  2/26 (7.69%)  0/28 (0.00%) 
Pneumonia * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  1/26 (3.85%)  0/28 (0.00%) 
Tinea pedis * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Upper respiratory tract infection * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Viral upper respiratory tract infection * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Vulvovaginal candidiasis * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Vulvovaginitis trichomonal * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Injury, poisoning and procedural complications           
Fall * 1  0/28 (0.00%)  1/27 (3.70%)  1/27 (3.70%)  1/26 (3.85%)  1/28 (3.57%) 
Foot fracture * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Joint sprain * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Spinal compression fracture * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Thermal burn * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Investigations           
Alanine aminotransferase increased * 1  1/28 (3.57%)  2/27 (7.41%)  6/27 (22.22%)  2/26 (7.69%)  1/28 (3.57%) 
Apolipoprotein A-I increased * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Aspartate aminotransferase increased * 1  1/28 (3.57%)  2/27 (7.41%)  4/27 (14.81%)  1/26 (3.85%)  1/28 (3.57%) 
Blood alkaline phosphatase increased * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Blood cholesterol increased * 1  0/28 (0.00%)  3/27 (11.11%)  1/27 (3.70%)  1/26 (3.85%)  0/28 (0.00%) 
Blood creatine phosphokinase MM increased * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Blood triglycerides increased * 1  1/28 (3.57%)  1/27 (3.70%)  1/27 (3.70%)  2/26 (7.69%)  0/28 (0.00%) 
Epstein-Barr virus test positive * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Haemoglobin decreased * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Low density lipoprotein increased * 1  0/28 (0.00%)  2/27 (7.41%)  1/27 (3.70%)  2/26 (7.69%)  0/28 (0.00%) 
Lymphocyte count decreased * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Lymphocyte percentage decreased * 1  0/28 (0.00%)  1/27 (3.70%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Viral DNA test positive * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
White blood cell count decreased * 1  0/28 (0.00%)  0/27 (0.00%)  2/27 (7.41%)  1/26 (3.85%)  0/28 (0.00%) 
Metabolism and nutrition disorders           
Hypercholesterolaemia * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Back pain * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Intervertebral disc protrusion * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Joint swelling * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Monarthritis * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Muscle fatigue * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Muscle tightness * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Musculoskeletal pain * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Myalgia * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Synovial cyst * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Nervous system disorders           
Cervical myelopathy * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Dizziness * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Headache * 1  2/28 (7.14%)  0/27 (0.00%)  2/27 (7.41%)  0/26 (0.00%)  1/28 (3.57%) 
Hypoaesthesia * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Sciatica * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Psychiatric disorders           
Insomnia * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Renal and urinary disorders           
Calculus ureteric * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Cystitis-like symptom * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Enuresis * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Urinary incontinence * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Reproductive system and breast disorders           
Breast pain * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Dysmenorrhoea * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Metrorrhagia * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  0/28 (0.00%)  1/27 (3.70%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Pleural effusion * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Upper respiratory tract inflammation * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis contact * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Erythema * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  2/28 (7.14%) 
Haemorrhage subcutaneous * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Hyperhidrosis * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
Pruritus * 1  1/28 (3.57%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Purpura * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Rash * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  2/26 (7.69%)  0/28 (0.00%) 
Skin ulcer * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Vascular disorders           
Peritonsillitis * 1  0/28 (0.00%)  0/27 (0.00%)  0/27 (0.00%)  1/26 (3.85%)  0/28 (0.00%) 
Hypertension * 1  0/28 (0.00%)  0/27 (0.00%)  1/27 (3.70%)  0/26 (0.00%)  0/28 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v11.1
[Not Specified]
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: NCT00603512    
Other Study ID Numbers: A3921039
First Submitted: January 17, 2008
First Posted: January 29, 2008
Results First Submitted: November 14, 2012
Results First Posted: January 25, 2013
Last Update Posted: January 25, 2013