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Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

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ClinicalTrials.gov Identifier: NCT00147498
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : January 30, 2013
Last Update Posted : January 30, 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 Rheumatoid Arthritis
Interventions Drug: CP-690,550
Other: Placebo
Enrollment 264
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Period Title: Overall Study
Started 61 69 69 65
Completed 58 60 52 48
Not Completed 3 9 17 17
Reason Not Completed
Adverse Event             1             6             7             3
Lack of Efficacy             1             1             1             8
Laboratory abnormality             0             0             2             0
Participant defaulted             0             1             4             3
Other             1             1             3             3
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo Total
Hide Arm/Group Description CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 61 69 69 65 264
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 69 participants 69 participants 65 participants 264 participants
47.9  (10.8) 51.8  (13.0) 51.1  (10.6) 51.3  (12.1) 50.6  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 69 participants 69 participants 65 participants 264 participants
Female
53
  86.9%
58
  84.1%
60
  87.0%
55
  84.6%
226
  85.6%
Male
8
  13.1%
11
  15.9%
9
  13.0%
10
  15.4%
38
  14.4%
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6
Hide Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints 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 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 61 69 69 65
Measure Type: Number
Unit of Measure: percentage of participants
70.49 81.16 76.81 29.23
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, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, and 4. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 61 69 69 65
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n=61,69,69,65) 27.87 43.48 56.52 12.31
Week 2 (n=61,69,69,65) 50.82 71.01 68.12 20.00
Week 4 (n=61,69,69,65) 63.93 75.36 75.36 30.77
Week 8 (n=56,56,51,45) 50.00 66.07 70.59 28.89
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 response: >= 50% improvement in TJC or SJC 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, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 61 69 69 65
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n= 61,69,69,65) 6.56 8.70 18.84 3.08
Week 2 (n= 61,69,69,65) 9.84 23.19 28.99 3.08
Week 4 (n= 61,69,69,65) 32.79 42.03 42.03 6.15
Week 6 (n= 61,69,69,65) 32.79 53.62 50.72 6.15
Week 8 (n=56,56,51,45) 17.86 30.36 45.10 13.33
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 response: >= 70% improvement in TJC or SJC 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, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 61 69 69 65
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n= 61,69,69,65) 1.64 4.35 4.35 0.00
Week 2 (n= 61,69,69,65) 4.92 4.35 10.14 1.54
Week 4 (n= 61,69,69,65) 9.84 17.39 21.74 1.54
Week 6 (n= 61,69,69,65) 13.11 21.74 27.54 3.08
Week 8 (n=56,56,51,45) 8.93 14.29 27.45 8.89
5.Secondary Outcome
Title Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
Hide Description ACR-n: calculated 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. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.
Time Frame Baseline up to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 59 69 66 62
Mean (Standard Deviation)
Unit of Measure: units on a scale*weeks
857.50  (1151.36) 1086.90  (1664.77) 1211.93  (2107.65) -546.41  (1721.78)
6.Secondary Outcome
Title Tender Joints 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, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 61 69 68 65
Mean (Standard Error)
Unit of Measure: tender joints
Baseline (n=61,69,68,65) 32.37  (1.588) 26.98  (1.485) 29.52  (1.499) 30.61  (1.529)
Week 1 (n=60,68,66,59) 23.49  (1.597) 16.62  (1.492) 15.75  (1.511) 27.39  (1.576)
Week 2 (n=57,66,65,60) 18.90  (1.622) 12.72  (1.505) 13.51  (1.519) 24.71  (1.572)
Week 4 (n=56,58,59,49) 15.33  (1.628) 9.97  (1.562) 10.17  (1.562) 19.78  (1.670)
Week 6 (n=56,59,53,50) 12.21  (1.630) 8.58  (1.556) 7.41  (1.612) 19.81  (1.661)
Week 8 (n=57,56,52,45) 16.32  (1.62) 11.50  (1.58) 11.21  (1.62) 20.37  (1.71)
7.Secondary Outcome
Title Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8
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 indicated an improvement.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 60 68 65 59
Mean (Standard Error)
Unit of Measure: tender joints
Change at Week 1 (n=60,68,65,59) -7.06  (1.435) -11.70  (1.338) -14.14  (1.362) -2.74  (1.417)
Change at Week 2 (n=57,66,65,60) -11.68  (1.459) -15.66  (1.350) -15.78  (1.365) -5.13  (1.416)
Change at Week 4 (n=56,58,58,49) -15.23  (1.465) -18.33  (1.403) -18.66  (1.413) -10.09  (1.508)
Change at Week 6 (n=56,59,52,50) -18.35  (1.466) -19.81  (1.398) -21.37  (1.461) -9.69  (1.500)
Change at Week 8 (n=57,56,52,45) -14.26  (1.46) -16.89  (1.42) -17.78  (1.46) -9.34  (1.55)
8.Secondary Outcome
Title Swollen Joints 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, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 61 69 68 65
Mean (Standard Error)
Unit of Measure: swollen joints
Baseline (n=61,69,68,65) 21.33  (1.052) 16.42  (0.984) 19.53  (0.993) 19.97  (1.013)
Week 1 (n=60,68,66,59) 14.77  (1.058) 9.90  (0.989) 10.18  (1.001) 16.46  (1.044)
Week 2 (n=57,66,65,60) 12.04  (1.074) 6.84  (0.997) 7.99  (1.006) 14.30  (1.041)
Week 4 (n=56,58,59,49) 8.83  (1.079) 5.95  (1.035) 6.42  (1.035) 11.78  (1.107)
Week 6 (n=56,59,53,50) 7.74  (1.080) 4.93  (1.031) 4.95  (1.069) 11.15  (1.101)
Week 8 (n=57,56,52,45) 10.31  (1.07) 6.02  (1.05) 6.77  (1.08) 12.36  (1.14)
9.Secondary Outcome
Title Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8
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, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 60 68 65 60
Mean (Standard Error)
Unit of Measure: swollen joints
Change at Week 1 (n=60,68,65,59) -5.02  (0.913) -8.20  (0.855) -9.00  (0.866) -3.19  (0.900)
Change at Week 2 (n=57,66,65,60) -7.83  (0.927) -11.33  (0.863) -11.11  (0.868) -5.23  (0.900)
Change at Week 4 (n=56,58,58,49) -11.03  (0.930) -12.10  (0.894) -12.58  (0.897) -7.73  (0.954)
Change at Week 6 (n=56,59,52,50) -12.10  (0.931) -13.13  (0.891) -13.91  (0.925) -8.06  (0.950)
Change at Week 8 (n=57,56,52,45) -9.54  (0.93) -12.02  (0.90) -12.14  (0.93) -7.00  (0.98)
10.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 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 58 67 65 63
Mean (Standard Error)
Unit of Measure: mm
Baseline (n=57,67,65,63) 71.03  (3.126) 69.37  (2.887) 63.99  (2.941) 65.73  (2.985)
Week 1 (n=58,67,64,58) 49.89  (3.111) 45.36  (2.889) 39.79  (2.958) 61.48  (3.076)
Week 2 (n=55,65,62,60) 46.18  (3.171) 41.09  (2.917) 32.09  (2.992) 58.02  (3.046)
Week 4 (n=56,58,58,48) 38.67  (3.146) 29.53  (3.033) 26.16  (3.062) 52.55  (3.294)
Week 6 (n=55,59,52,49) 37.11  (3.165) 28.82  (3.018) 24.52  (3.180) 50.04  (3.273)
Week 8 (n=57,57,50,45) 40.29  (3.13) 37.56  (3.05) 30.63  (3.23) 50.76  (3.37)
11.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8
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 mm = very well and 100 mm = very poorly.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 56 66 62 59
Mean (Standard Error)
Unit of Measure: mm
Change at Week 1 (n=56,66,62,57) -17.98  (3.121) -21.56  (2.859) -26.16  (2.948) -5.18  (3.022)
Change at Week 2 (n=53,63,60,59) -22.06  (3.184) -25.71  (2.900) -33.33  (2.984) -8.14  (2.998)
Change at Week 4 (n=53,57,55,47) -30.23  (3.176) -37.35  (3.001) -38.71  (3.072) -13.17  (3.238)
Change at Week 6 (n=52,57,49,48) -31.64  (3.203) -37.78  (3.005) -40.50  (3.191) -15.06  (3.219)
Change at Week 8 (n=53,55,48,45) -27.83  (3.18) -28.79  (3.04) -34.30  (3.21) -14.96  (3.28)
12.Secondary Outcome
Title Physician Global Assessment of Arthritis
Hide Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 60 69 66 64
Mean (Standard Error)
Unit of Measure: mm
Baseline (n=60,69,66,64) 69.39  (2.566) 64.11  (2.388) 66.65  (2.436) 67.75  (2.471)
Week 1 (n=60,67,64,58) 49.85  (2.568) 37.80  (2.417) 36.30  (2.464) 55.54  (2.575)
Week 2 (n=57,66,65,60) 41.65  (2.618) 29.54  (2.430) 32.24  (2.453) 52.76  (2.546)
Week 4 (n=56,58,59,49) 34.18  (2.631) 27.45  (2.547) 23.91  (2.540) 46.01  (2.746)
Week 6 (n=55,58,53,50) 31.42  (2.651) 22.22  (2.549) 19.26  (2.643) 46.52  (2.727)
Week 8 (n=57,57,52,45) 39.10  (2.62) 30.78  (2.57) 26.24  (2.66) 42.04  (2.84)
13.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8
Hide Description Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 59 67 63 59
Mean (Standard Error)
Unit of Measure: mm
Change at Week 1 (n=59,67,62,57) -17.13  (2.626) -28.25  (2.445) -30.89  (2.534) -12.25  (2.636)
Change at Week 2 (n=56,66,63,59) -25.43  (2.675) -36.60  (2.456) -34.56  (2.525) -14.29  (2.611)
Change at Week 4 (n=55,58,56,48) -33.29  (2.686) -38.44  (2.563) -42.65  (2.627) -20.91  (2.803)
Change at Week 6 (n=55,58,50,49) -35.97  (2.690) -43.69  (2.566) -46.70  (2.730) -19.87  (2.786)
Change at Week 8 (n=56,57,50,45) -29.19  (2.67) -35.11  (2.58) -39.81  (2.73) -24.78  (2.87)
14.Secondary Outcome
Title Patient Assessment of Arthritis Pain
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 59 68 66 64
Mean (Standard Error)
Unit of Measure: mm
Baseline (n=59,68,66,64) 69.46  (3.112) 67.47  (2.894) 68.13  (2.936) 64.17  (2.980)
Week 1 (n=59,68,65,59) 51.76  (3.114) 46.11  (2.897) 37.71  (2.953) 62.51  (3.072)
Week 2 (n=57,65,65,60) 45.59  (3.154) 40.14  (2.940) 30.83  (2.956) 60.65  (3.062)
Week 4 (n=57,58,59,49) 37.77  (3.150) 30.42  (3.057) 26.76  (3.053) 56.96  (3.287)
Week 6 (n=55,59,53,50) 35.57  (3.191) 28.35  (3.043) 23.39  (3.169) 52.75  (3.266)
Week 8 (n=57,57,52,45) 42.44  (3.15) 37.62  (3.08) 31.12  (3.19) 49.06  (3.39)
15.Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 57 67 63 59
Mean (Standard Error)
Unit of Measure: mm
Change at Week 1 (n=57,67,63,58) -15.01  (3.102) -19.74  (2.843) -29.66  (2.932) -3.30  (3.027)
Change at Week 2 (n=55,65,63,59) -21.44  (3.142) -26.10  (2.870) -35.85  (2.936) -4.79  (3.027)
Change at Week 4 (n=55,57,56,48) -29.27  (3.137) -35.47  (2.996) -40.10  (3.050) -8.40  (3.242)
Change at Week 6 (n=54,58,51,49) -31.42  (3.159) -37.67  (2.983) -42.89  (3.144) -12.26  (3.223)
Change at Week 8 (n=55,56,51,45) -24.90  (3.14) -28.70  (3.02) -35.35  (3.15) -16.28  (3.31)
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, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 60 69 67 62
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline (n=60,69,67,62) 1.75  (0.086) 1.66  (0.080) 1.61  (0.081) 1.71  (0.083)
Week 1 (n=60,68,65,58) 1.46  (0.086) 1.37  (0.080) 1.19  (0.082) 1.63  (0.084)
Week 2 (n=57,66,64,60) 1.32  (0.087) 1.17  (0.081) 1.06  (0.082) 1.53  (0.084)
Week 4 (n=57,57,59,47) 1.17  (0.087) 1.07  (0.083) 0.92  (0.083) 1.54  (0.088)
Week 6 (n=54,59,53,50) 1.12  (0.088) 0.95  (0.082) 0.86  (0.084) 1.47  (0.087)
Week 8 (n=57,56,52,45) 1.30  (0.09) 1.06  (0.08) 0.92  (0.08) 1.52  (0.09)
17.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8
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, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 59 68 64 57
Mean (Standard Error)
Unit of Measure: units on a scale
Change at Week 1 (n=59,68,64,55) -0.25  (0.066) -0.30  (0.061) -0.44  (0.063) -0.05  (0.067)
Change at Week 2 (n=56,66,63,57) -0.39  (0.067) -0.50  (0.062) -0.56  (0.063) -0.15  (0.067)
Change at Week 4 (n=56,57,57,44) -0.55  (0.067) -0.60  (0.064) -0.69  (0.065) -0.13  (0.071)
Change at Week 6 (n=55,59,51,47) -0.60  (0.068) -0.72  (0.063) -0.74  (0.067) -0.20  (0.070)
Change at Week 8 (n=56,56,51,43) -0.43  (0.07) -0.60  (0.06) -0.70  (0.07) -0.17  (0.07)
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 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 50 57 58 53
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline (n=50,57,58,53) 31.25  (35.00) 25.47  (31.06) 28.10  (28.43) 22.28  (18.52)
Week 1 (n=50,55,55,49) 15.98  (16.72) 7.57  (9.79) 7.57  (11.32) 25.40  (30.04)
Week 2 (n=46,53,53,48) 13.18  (12.97) 7.25  (11.83) 6.50  (14.81) 24.41  (21.38)
Week 4 (n=46,49,47,39) 11.83  (11.10) 5.17  (6.72) 5.88  (10.98) 22.26  (21.07)
Week 6 (n=45,49,41,41) 12.57  (21.01) 6.59  (16.37) 6.08  (11.80) 22.94  (20.79)
Week 8 (n=45,45,41,37) 23.37  (22.72) 12.06  (12.20) 13.95  (14.68) 23.64  (29.47)
19.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8
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 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 50 54 55 48
Mean (Standard Deviation)
Unit of Measure: mg/L
Change at Week 1 (n=50,54,55,48) -15.28  (26.65) -18.29  (28.98) -21.38  (25.56) -0.24  (15.40)
Change at Week 2 (n=46,52,53,48) -16.74  (32.94) -18.89  (31.87) -23.06  (31.49) 1.79  (15.56)
Change at Week 4 (n=46,49,47,39) -17.76  (33.31) -22.02  (31.29) -20.70  (25.69) -0.67  (19.17)
Change at Week 6 (n=45,49,41,41) -17.83  (35.92) -18.08  (25.99) -17.58  (24.76) 0.67  (16.81)
Change at Week 8 (n=45,45,41,37) -7.06  (35.75) -13.24  (27.69) -11.81  (29.46) 1.32  (27.26)
20.Secondary Outcome
Title Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Hide Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 50 57 56 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=50,57,56,51) 6.17  (0.89) 5.69  (0.92) 5.91  (0.91) 6.00  (0.90)
Week 1 (n=49,54,54,47) 5.29  (1.08) 4.42  (1.12) 4.28  (1.21) 5.66  (1.10)
Week 2 (n=46,53,51,48) 4.93  (1.08) 3.80  (1.17) 3.90  (1.17) 5.37  (1.15)
Week 4 (n=46,49,47,39) 4.44  (1.20) 3.56  (1.12) 3.46  (1.33) 4.91  (1.22)
Week 6 (n=45,49,40,41) 4.18  (1.29) 3.42  (1.16) 3.10  (1.17) 4.78  (1.05)
Week 8 (n=45,44,41,36) 4.75  (1.37) 4.08  (1.32) 3.93  (1.38) 5.02  (1.10)
21.Secondary Outcome
Title Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8
Hide Description DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized to study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable for a particular time-point for each treatment arm, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 49 53 52 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 1 (n=49,53,52,45) -0.84  (0.74) -1.28  (0.99) -1.65  (0.99) -0.39  (0.86)
Change at Week 2 (n=46,52,50,46) -1.19  (0.89) -1.91  (1.23) -2.05  (1.25) -0.59  (0.98)
Change at Week 4 (n=46,49,46,37) -1.64  (1.16) -2.18  (1.25) -2.47  (1.39) -1.04  (1.04)
Change at Week 6 (n=45,49,39,39) -1.99  (1.28) -2.28  (1.33) -2.73  (1.32) -1.20  (1.17)
Change at Week 8 (n=45,44,41,35) -1.36  (1.32) -1.60  (1.32) -1.99  (1.38) -0.89  (1.07)
22.Secondary Outcome
Title Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)
Hide Description Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.
Time Frame Baseline, Week 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study treatment. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' is number of participants evaluable at specific time points for each arm group, respectively.
Arm/Group Title CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description:
CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
Overall Number of Participants Analyzed 49 53 52 46
Measure Type: Number
Unit of Measure: participants
Week 1, No Change (n=49,53,52,45) 31 25 17 35
Week 1, Good (n=49,53,52,45) 0 0 0 0
Week 1, Moderate (n=49,53,52,45) 18 28 35 10
Week 2, No Change (n=46,52,50,46) 20 13 12 33
Week 2, Good (n=46,52,50,46) 0 0 0 0
Week 2, Moderate (n=46,52,50,46) 26 39 38 13
Week 4, No Change (n=46,49,46,37) 14 7 8 22
Week 4, Good (n=46,49,46,37) 0 0 0 0
Week 4, Moderate (n=46,49,46,37) 32 42 38 15
Week 6, No Change (n=45,49,39,39) 11 8 3 20
Week 6, Good (n=45,49,39,39) 0 0 0 0
Week 6, Moderate (n=45,49,39,39) 34 41 36 19
Week 8, No Change (n=45,44,41,35) 21 16 11 24
Week 8, Good (n=45,44,41,35) 0 0 0 0
Week 8, Moderate (n=45,44,41,35) 24 28 30 11
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 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Hide Arm/Group Description CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks. CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks. CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks. Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
All-Cause Mortality
CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/61 (1.64%)   5/69 (7.25%)   3/69 (4.35%)   1/65 (1.54%) 
Blood and lymphatic system disorders         
Leukopenia * 1  0/61 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/65 (0.00%) 
Cardiac disorders         
Myocardial ischaemia * 1  0/61 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Infections and infestations         
Gastroenteritis * 1  0/61 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/65 (0.00%) 
Pneumonia staphylococcal * 1  0/61 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  1/65 (1.54%) 
Pyelonephritis acute * 1  0/61 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Whipple's disease * 1  0/61 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Musculoskeletal and connective tissue disorders         
Rheumatoid arthritis * 1  0/61 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/65 (0.00%) 
Nervous system disorders         
Subarachnoid haemorrhage * 1  1/61 (1.64%)  0/69 (0.00%)  0/69 (0.00%)  0/65 (0.00%) 
Syncope vasovagal * 1  0/61 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/65 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous * 1  0/61 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/65 (0.00%) 
Pregnancy * 1  0/61 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  0/65 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CP 690,550 5 mg CP-690,550 15 mg CP-690,550 30 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/61 (55.74%)   38/69 (55.07%)   46/69 (66.67%)   37/65 (56.92%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/61 (1.64%)  2/69 (2.90%)  4/69 (5.80%)  3/65 (4.62%) 
Leukopenia * 1  2/61 (3.28%)  1/69 (1.45%)  7/69 (10.14%)  1/65 (1.54%) 
Lymphopenia * 1  0/61 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  0/65 (0.00%) 
Neutropenia * 1  1/61 (1.64%)  1/69 (1.45%)  3/69 (4.35%)  0/65 (0.00%) 
Thrombocytopenia * 1  0/61 (0.00%)  1/69 (1.45%)  2/69 (2.90%)  0/65 (0.00%) 
Cardiac disorders         
Atrioventricular block first degree * 1  0/61 (0.00%)  2/69 (2.90%)  0/69 (0.00%)  0/65 (0.00%) 
Cardiac disorder * 1  0/61 (0.00%)  2/69 (2.90%)  0/69 (0.00%)  0/65 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/61 (0.00%)  2/69 (2.90%)  1/69 (1.45%)  0/65 (0.00%) 
Abdominal pain upper * 1  4/61 (6.56%)  2/69 (2.90%)  2/69 (2.90%)  0/65 (0.00%) 
Constipation * 1  3/61 (4.92%)  0/69 (0.00%)  0/69 (0.00%)  2/65 (3.08%) 
Diarrhoea * 1  3/61 (4.92%)  2/69 (2.90%)  3/69 (4.35%)  3/65 (4.62%) 
Dry mouth * 1  2/61 (3.28%)  0/69 (0.00%)  0/69 (0.00%)  0/65 (0.00%) 
Dyspepsia * 1  0/61 (0.00%)  2/69 (2.90%)  2/69 (2.90%)  1/65 (1.54%) 
Gastritis * 1  0/61 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  2/65 (3.08%) 
Nausea * 1  4/61 (6.56%)  3/69 (4.35%)  6/69 (8.70%)  3/65 (4.62%) 
Toothache * 1  0/61 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  1/65 (1.54%) 
Vomiting * 1  3/61 (4.92%)  1/69 (1.45%)  3/69 (4.35%)  2/65 (3.08%) 
General disorders         
Asthenia * 1  0/61 (0.00%)  0/69 (0.00%)  1/69 (1.45%)  2/65 (3.08%) 
Fatigue * 1  1/61 (1.64%)  2/69 (2.90%)  1/69 (1.45%)  0/65 (0.00%) 
Malaise * 1  0/61 (0.00%)  1/69 (1.45%)  3/69 (4.35%)  0/65 (0.00%) 
Oedema peripheral * 1  3/61 (4.92%)  1/69 (1.45%)  3/69 (4.35%)  2/65 (3.08%) 
Infections and infestations         
Gastroenteritis * 1  2/61 (3.28%)  2/69 (2.90%)  1/69 (1.45%)  1/65 (1.54%) 
Herpes simplex * 1  0/61 (0.00%)  2/69 (2.90%)  2/69 (2.90%)  0/65 (0.00%) 
Influenza * 1  3/61 (4.92%)  2/69 (2.90%)  4/69 (5.80%)  2/65 (3.08%) 
Nasopharyngitis * 1  3/61 (4.92%)  1/69 (1.45%)  1/69 (1.45%)  1/65 (1.54%) 
Sinusitis * 1  0/61 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  3/65 (4.62%) 
Tinea pedis * 1  0/61 (0.00%)  3/69 (4.35%)  1/69 (1.45%)  0/65 (0.00%) 
Tinea versicolour * 1  2/61 (3.28%)  0/69 (0.00%)  0/69 (0.00%)  0/65 (0.00%) 
Upper respiratory tract infection * 1  0/61 (0.00%)  3/69 (4.35%)  1/69 (1.45%)  4/65 (6.15%) 
Urinary tract infection * 1  1/61 (1.64%)  0/69 (0.00%)  5/69 (7.25%)  2/65 (3.08%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/61 (0.00%)  2/69 (2.90%)  1/69 (1.45%)  1/65 (1.54%) 
Investigations         
Alanine aminotransferase increased * 1  1/61 (1.64%)  0/69 (0.00%)  0/69 (0.00%)  3/65 (4.62%) 
Blood lactate dehydrogenase increased * 1  0/61 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  2/65 (3.08%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia * 1  2/61 (3.28%)  4/69 (5.80%)  0/69 (0.00%)  0/65 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  3/61 (4.92%)  0/69 (0.00%)  3/69 (4.35%)  6/65 (9.23%) 
Back pain * 1  1/61 (1.64%)  3/69 (4.35%)  1/69 (1.45%)  3/65 (4.62%) 
Muscle spasms * 1  0/61 (0.00%)  0/69 (0.00%)  0/69 (0.00%)  2/65 (3.08%) 
Pain in extremity * 1  0/61 (0.00%)  3/69 (4.35%)  1/69 (1.45%)  0/65 (0.00%) 
Rheumatoid arthritis * 1  1/61 (1.64%)  3/69 (4.35%)  2/69 (2.90%)  4/65 (6.15%) 
Shoulder pain * 1  0/61 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  1/65 (1.54%) 
Nervous system disorders         
Dizziness * 1  0/61 (0.00%)  4/69 (5.80%)  3/69 (4.35%)  1/65 (1.54%) 
Headache * 1  10/61 (16.39%)  8/69 (11.59%)  17/69 (24.64%)  6/65 (9.23%) 
Somnolence * 1  0/61 (0.00%)  2/69 (2.90%)  2/69 (2.90%)  1/65 (1.54%) 
Renal and urinary disorders         
Leukocyturia * 1  2/61 (3.28%)  1/69 (1.45%)  1/69 (1.45%)  0/65 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  2/61 (3.28%)  0/69 (0.00%)  0/69 (0.00%)  0/65 (0.00%) 
Pharyngolaryngeal pain * 1  0/61 (0.00%)  3/69 (4.35%)  3/69 (4.35%)  1/65 (1.54%) 
Skin and subcutaneous tissue disorders         
Acne * 1  0/61 (0.00%)  1/69 (1.45%)  3/69 (4.35%)  0/65 (0.00%) 
Ecchymosis * 1  0/61 (0.00%)  0/69 (0.00%)  2/69 (2.90%)  0/65 (0.00%) 
Pruritus * 1  0/61 (0.00%)  1/69 (1.45%)  0/69 (0.00%)  2/65 (3.08%) 
Rash * 1  0/61 (0.00%)  3/69 (4.35%)  3/69 (4.35%)  1/65 (1.54%) 
Vascular disorders         
Hypertension * 1  1/61 (1.64%)  2/69 (2.90%)  3/69 (4.35%)  0/65 (0.00%) 
Hypotension * 1  1/61 (1.64%)  0/69 (0.00%)  0/69 (0.00%)  2/65 (3.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: NCT00147498    
Other Study ID Numbers: A3921019
First Submitted: September 2, 2005
First Posted: September 7, 2005
Results First Submitted: November 19, 2012
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013