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Trial record 1 of 1 for:    A3921041
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Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan

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ClinicalTrials.gov Identifier: NCT00661661
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: CP-690,550
Enrollment 487
Recruitment Details  
Pre-assignment Details Participants received study drug (CP-690,550 or placebo) in the precedent study A3921039 (NCT00603512) for 12 weeks, A3921040 (NCT00687193) for 12 weeks, or A3921044 (NCT00847613) for 2 years.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID
Hide Arm/Group Description CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
Period Title: Overall Study
Started 382 105
Completed 242 66
Not Completed 140 39
Reason Not Completed
Adverse Event             99             24
Lack of Efficacy             3             2
Lost to Follow-up             0             1
Withdrawal by Subject             15             5
Other             22             7
Not assigned treatment             1             0
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. Total of all reporting groups
Overall Number of Baseline Participants 381 105 486
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 381 participants 105 participants 486 participants
53.5  (11.2) 49.3  (11.7) 52.6  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 381 participants 105 participants 486 participants
Female
318
  83.5%
86
  81.9%
404
  83.1%
Male
63
  16.5%
19
  18.1%
82
  16.9%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.
Time Frame Baseline up to Week 288
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: all participants who received at least 1 dose of study medication in current study.
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Measure Type: Number
Unit of Measure: Particiants
Number of participants with AEs (including SAEs) 371 105 476
Number of participants with SAEs 111 28 139
2.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Hide Description ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant 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). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n= 378, 105, 483) 80.2 68.6 77.6
Week 4 (n=373, 105, 478) 87.1 70.5 83.5
Week 8 (n=371, 105, 476) 90.0 72.4 86.1
Week 12 (n=370, 105, 475) 91.9 77.1 88.6
Week 24 (n=357, 104, 461) 90.8 85.6 89.6
Week 36 (n=339, 102, 441) 94.1 87.3 92.5
Week 48 (n=331, 102, 433) 93.7 88.2 92.4
Week 60 (n=323, 102, 425) 92.3 90.2 91.8
Week 72 (n=315, 99, 414) 92.4 86.9 91.1
Week 84 (n=309, 92, 401) 93.2 87.0 91.8
Week 96 (n=281, 87, 368) 92.2 92.0 92.1
Week 108 (n=259, 84, 343) 91.9 86.9 90.7
Week 120 (n=242, 80, 322) 91.3 88.8 90.7
Week 132 (n=232, 79, 311) 92.2 84.8 90.4
Week 144 (n=224, 76, 300) 89.7 86.8 89.0
Week 156 (n=219, 73, 292) 91.3 84.9 89.7
Week 168 (n=213, 70, 283) 92.5 82.9 90.1
Week 180 (n=180, 57, 237) 92.8 86.0 91.1
Week 192 (n=138, 42, 180) 92.8 85.7 91.1
Week 204 (n=109, 30, 139) 92.7 90.0 92.1
Week 216 (n=76, 13, 89) 96.1 84.6 94.4
Week 228 (n=68, 5, 73) 91.2 80.0 90.4
Week 240 (n=65, 5, 70) 93.8 80.0 92.9
Week 252 (n=65, 5, 70) 92.3 80.0 91.4
Week 264 (n=59, 5, 64) 89.8 80.0 89.1
Week 276 (n=22, 1, 23) 95.5 100 95.7
Week 288 (n=3, 0, 3) 100 0 100
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n= 378, 105, 483) 59.5 36.2 54.5
Week 4 (n=373, 105, 478) 63.8 35.2 57.5
Week 8 (n=371, 105, 476) 70.4 47.6 65.3
Week 12 (n=370, 105, 475) 70.8 46.7 65.5
Week 24 (n=357, 104, 461) 76.2 62.5 73.1
Week 36 (n=339, 102, 441) 77.3 56.9 72.6
Week 48 (n=331, 102, 433) 77.3 59.8 73.2
Week 60 (n=323, 102, 425) 77.1 66.7 74.6
Week 72 (n=315, 99, 414) 77.8 74.7 77.1
Week 84 (n=309, 92, 401) 78.6 64.1 75.3
Week 96 (n=281, 87, 368) 78.3 60.9 74.2
Week 108 (n=259, 84, 343) 79.9 72.6 78.1
Week 120 (n=242, 80, 322) 76.4 68.8 74.5
Week 132 (n=232, 79, 311) 77.2 72.2 75.9
Week 144 (n=224, 76, 300) 78.1 69.7 76.0
Week 156 (n=219, 73, 292) 79.5 65.8 76.0
Week 168 (n=213, 70, 283) 79.3 67.1 76.3
Week 180 (n=180, 57, 237) 82.2 71.9 79.7
Week 192 (n=138, 42, 180) 79.7 61.9 75.6
Week 204 (n=109, 30, 139) 84.4 80.0 83.5
Week 216 (n=76, 13, 89) 86.8 53.8 82.0
Week 228 (n=68, 5, 73) 76.5 80.0 76.7
Week 240 (n=65, 5, 70) 83.1 40.0 80.0
Week 252 (n=65, 5, 70) 86.2 40.0 82.9
Week 264 (n=59, 5, 64) 84.7 40.0 81.3
Week 276 (n=22, 1, 23) 81.8 100 82.6
Week 288 (n=3, 0, 3) 100 0 100
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n= 378, 105, 483) 37.0 19.0 33.1
Week 4 (n=373, 105, 478) 44.8 20.2 39.3
Week 8 (n=371, 105, 476) 47.7 21.0 41.8
Week 12 (n=370, 105, 475) 50.0 16.2 42.5
Week 24 (n=357, 104, 461) 54.1 27.9 48.2
Week 36 (n=339, 102, 441) 56.6 24.5 49.2
Week 48 (n=331, 102, 433) 59.8 34.3 53.8
Week 60 (n=323, 102, 425) 59.1 37.3 53.9
Week 72 (n=315, 99, 414) 61.9 38.4 56.3
Week 84 (n=309, 92, 401) 60.2 35.9 54.6
Week 96 (n=281, 87, 368) 59.4 42.5 55.4
Week 108 (n=259, 84, 343) 60.6 42.9 56.3
Week 120 (n=242, 80, 322) 62.0 37.5 55.9
Week 132 (n=232, 79, 311) 60.8 40.5 55.6
Week 144 (n=224, 76, 300) 61.2 35.5 54.7
Week 156 (n=219, 73, 292) 61.6 41.1 56.5
Week 168 (n=213, 70, 283) 62.9 41.4 57.6
Week 180 (n=180, 57, 237) 63.9 47.4 59.9
Week 192 (n=138, 42, 180) 63.8 42.9 58.9
Week 204 (n=109, 30, 139) 62.4 56.7 61.2
Week 216 (n=76, 13, 89) 69.7 30.8 64.0
Week 228 (n=68, 5, 73) 63.2 20.0 60.3
Week 240 (n=65, 5, 70) 69.2 20.0 65.7
Week 252 (n=65, 5, 70) 73.8 20.0 70.0
Week 264 (n=59, 5, 64) 71.2 20.0 67.2
Week 276 (n=22, 1, 23) 68.2 0 65.2
Week 288 (n=3, 0, 3) 66.7 0 66.7
5.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
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, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n= 378, 105, 483) -0.55  (0.03) -0.44  (0.05) -0.53  (0.03)
Week 4 (n=372, 105, 477) -0.61  (0.03) -0.45  (0.05) -0.57  (0.03)
Week 8 (n=371, 105, 476) -0.66  (0.03) -0.49  (0.05) -0.62  (0.03)
Week 12 (n=370, 105, 475) -0.66  (0.03) -0.51  (0.05) -0.63  (0.03)
Week 24 (n=357, 104, 461) -0.69  (0.03) -0.55  (0.05) -0.65  (0.03)
Week 36 (n=339, 102, 441) -0.70  (0.03) -0.54  (0.05) -0.66  (0.03)
Week 48 (n=331, 102, 433) -0.70  (0.03) -0.62  (0.05) -0.68  (0.03)
Week 60 (n=323, 102, 425) -0.71  (0.03) -0.57  (0.05) -0.67  (0.03)
Week 72 (n=315, 99, 414) -0.72  (0.03) -0.60  (0.05) -0.69  (0.03)
Week 84 (n=309, 92, 401) -0.72  (0.04) -0.61  (0.05) -0.69  (0.03)
Week 96 (n=281, 87, 368) -0.72  (0.04) -0.61  (0.06) -0.69  (0.03)
Week 108 (n=259, 84, 343) -0.70  (0.04) -0.64  (0.06) -0.69  (0.03)
Week 120 (n=242, 80, 322) -0.70  (0.04) -0.63  (0.06) -0.68  (0.03)
Week 132 (n=232, 79, 311) -0.70  (0.04) -0.64  (0.06) -0.68  (0.03)
Week 144 (n=224, 76, 300) -0.67  (0.04) -0.59  (0.07) -0.65  (0.04)
Week 156 (n=219, 72, 291) -0.68  (0.04) -0.62  (0.06) -0.66  (0.03)
Week 168 (n=213, 70, 283) -0.68  (0.04) -0.57  (0.07) -0.65  (0.04)
Week 180 (n=180, 57, 237) -0.70  (0.05) -0.63  (0.08) -0.68  (0.04)
Week 192 (n=138, 42, 180) -0.69  (0.05) -0.61  (0.09) -0.67  (0.05)
Week 204 (n=109, 30, 139) -0.67  (0.06) -0.67  (0.09) -0.67  (0.05)
Week 216 (n=76, 13, 89) -0.62  (0.06) -0.42  (0.09) -0.59  (0.05)
Week 228 (n=68, 5, 73) -0.62  (0.06) -0.25  (0.10) -0.59  (0.06)
Week 240 (n=65, 5, 70) -0.66  (0.06) -0.33  (0.14) -0.64  (0.06)
Week 252 (n=65, 5, 70) -0.68  (0.07) -0.25  (0.12) -0.65  (0.06)
Week 264 (n=59, 5, 64) -0.65  (0.07) -0.23  (0.07) -0.62  (0.07)
Week 276 (n=22, 1, 23) -0.83  (0.11) -0.63 [1]   (NA) -0.82  (0.11)
Week 288 (n=3, 0, 3) -0.96  (0.37) NA [2]   (NA) -0.96  (0.37)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
6.Secondary Outcome
Title Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Hide Description DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n= 378, 105, 483) -2.60  (0.07) -1.94  (0.13) -2.45  (0.06)
Week 4 (n=372, 105, 477) -2.77  (0.07) -1.95  (0.13) -2.59  (0.06)
Week 8 (n=371, 104, 475) -2.95  (0.06) -2.14  (0.12) -2.77  (0.06)
Week 12 (n=370, 105, 475) -3.01  (0.06) -2.08  (0.12) -2.81  (0.06)
Week 24 (n=357, 104, 461) -3.12  (0.06) -2.42  (0.12) -2.96  (0.06)
Week 36 (n=339, 102, 441) -3.18  (0.07) -2.54  (0.13) -3.03  (0.06)
Week 48 (n=331, 102, 433) -3.20  (0.07) -2.72  (0.13) -3.08  (0.06)
Week 60 (n=323, 101, 424) -3.25  (0.07) -2.80  (0.12) -3.15  (0.06)
Week 72 (n=315, 99, 414) -3.20  (0.07) -2.83  (0.12) -3.11  (0.06)
Week 84 (n=309, 92, 401) -3.26  (0.07) -2.86  (0.14) -3.17  (0.06)
Week 96 (n=281, 87, 368) -3.21  (0.07) -2.87  (0.14) -3.13  (0.07)
Week 108 (n=259, 83, 342) -3.22  (0.08) -2.83  (0.15) -3.12  (0.07)
Week 120 (n=242, 79, 321) -3.24  (0.08) -2.78  (0.14) -3.12  (0.07)
Week 132 (n=232, 79, 311) -3.14  (0.08) -2.84  (0.15) -3.07  (0.07)
Week 144 (n=224, 76, 300) -3.17  (0.09) -2.84  (0.16) -3.09  (0.08)
Week 156 (n=218, 72, 290) -3.08  (0.09) -2.84  (0.16) -3.02  (0.08)
Week 168 (n=213, 70, 283) -3.16  (0.09) -2.87  (0.17) -3.09  (0.08)
Week 180 (n=178, 56, 234) -3.21  (0.10) -3.06  (0.19) -3.18  (0.09)
Week 192 (n=138, 42, 180) -3.17  (0.11) -3.07  (0.19) -3.15  (0.09)
Week 204 (n=109, 30, 139) -3.24  (0.12) -3.35  (0.25) -3.26  (0.11)
Week 216 (n=76, 13, 89) -3.20  (0.13) -2.44  (0.44) -3.09  (0.13)
Week 228 (n=68, 5, 73) -3.08  (0.17) -2.25  (0.58) -3.02  (0.16)
Week 240 (n=65, 5, 70) -3.22  (0.15) -2.61  (0.70) -3.17  (0.14)
Week 252 (n=65, 5, 70) -3.33  (0.15) -1.81  (0.51) -3.23  (0.15)
Week 264 (n=59, 5, 64) -3.32  (0.15) -2.09  (0.45) -3.23  (0.14)
Week 276 (n=21, 1, 22) -3.34  (0.25) -2.15 [1]   (NA) -3.29  (0.24)
Week 288 (n=3, 0, 3) -2.95  (0.51) NA [2]   (NA) -2.95  (0.51)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
7.Secondary Outcome
Title Change From Baseline in Disease Activity Score Using 28-Joint 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n= 378, 105, 483) -2.44  (0.06) -1.90  (0.12) -2.32  (0.06)
Week 4 (n=372, 105, 477) -2.55  (0.06) -1.90  (0.12) -2.41  (0.06)
Week 8 (n=371, 105, 476) -2.68  (0.06) -2.06  (0.11) -2.55  (0.05)
Week 12 (n=370, 105, 475) -2.75  (0.06) -1.97  (0.11) -2.57  (0.05)
Week 24 (n=357, 104, 461) -2.85  (0.06) -2.29  (0.11) -2.72  (0.05)
Week 36 (n=337, 102, 439) -2.92  (0.06) -2.45  (0.11) -2.81  (0.05)
Week 48 (n=331, 102, 433) -2.92  (0.06) -2.58  (0.12) -2.84  (0.05)
Week 60 (n=322, 102, 424) -2.92  (0.06) -2.60  (0.11) -2.85  (0.05)
Week 72 (n=315, 99, 414) -2.93  (0.06) -2.61  (0.11) -2.86  (0.05)
Week 84 (n=309, 92, 401) -2.98  (0.06) -2.70  (0.12) -2.92  (0.06)
Week 96 (n=281, 87, 368) -2.95  (0.07) -2.69  (0.13) -2.88  (0.06)
Week 108 (n=259, 83, 342) -2.93  (0.07) -2.64  (0.13) -2.86  (0.06)
Week 120 (n=242, 80, 322) -2.97  (0.07) -2.60  (0.13) -2.88  (0.06)
Week 132 (n=231, 79, 310) -2.89  (0.07) -2.66  (0.13) -2.83  (0.06)
Week 144 (n=224, 76, 300) -2.90  (0.08) -2.68  (0.14) -2.85  (0.07)
Week 156 (n=219, 72, 291) -2.84  (0.08) -2.70  (0.14) -2.81  (0.07)
Week 168 (n=213, 70, 283) -2.90  (0.08) -2.68  (0.15) -2.84  (0.07)
Week 180 (n=180, 57, 237) -2.92  (0.09) -2.80  (0.17) -2.89  (0.08)
Week 192 (n=138, 42, 180) -2.93  (0.09) -2.84  (0.16) -2.91  (0.08)
Week 204 (n=109, 30, 139) -2.95  (0.11) -3.05  (0.22) -2.97  (0.10)
Week 216 (n=76, 13, 89) -2.94  (0.12) -2.46  (0.34) -2.87  (0.12)
Week 228 (n=68, 5, 73) -2.84  (0.17) -2.38  (0.44) -2.81  (0.16)
Week 240 (n=65, 5, 70) -2.97  (0.13) -2.36  (0.57) -2.92  (0.13)
Week 252 (n=65, 5, 70) -3.09  (0.14) -1.89  (0.42) -3.00  (0.14)
Week 264 (n=58, 5, 63) -3.13  (0.15) -1.86  (0.30) -3.03  (0.14)
Week 276 (n=22, 1, 23) -3.24  (0.24) -1.50 [1]   (NA) -3.16  (0.24)
Week 288 (n=3, 0, 3) -2.67  (0.27) NA [2]   (NA) -2.67  (0.27)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
8.Secondary Outcome
Title Change From Baseline in Patient Global Assessment of Arthritis
Hide Description Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n= 378, 105, 483) -34.52  (1.38) -25.38  (2.43) -32.54  (1.21)
Week 4 (n=372, 105, 477) -37.81  (1.36) -25.34  (2.61) -35.06  (1.23)
Week 8 (n=371, 105, 476) -39.61  (1.35) -28.86  (2.31) -37.24  (1.19)
Week 12 (n=370, 105, 475) -39.31  (1.38) -27.33  (2.23) -36.67  (1.20)
Week 24 (n=357, 104, 461) -40.67  (1.39) -30.75  (2.53) -38.43  (1.24)
Week 36 (n=339, 102, 441) -41.70  (1.42) -29.95  (2.63) -38.98  (1.27)
Week 48 (n=331, 102, 433) -41.03  (1.46) -32.48  (2.56) -39.02  (1.28)
Week 60 (n=323, 102, 425) -41.79  (1.44) -34.33  (2.42) -40.00  (1.25)
Week 72 (n=315, 99, 414) -41.30  (1.53) -35.38  (2.31) -39.88  (1.29)
Week 84 (n=309, 92, 401) -42.29  (1.53) -35.12  (2.63) -40.65  (1.33)
Week 96 (n=281, 87, 368) -41.90  (1.62) -34.98  (2.88) -40.27  (1.42)
Week 108 (n=259, 84, 343) -42.47  (1.67) -34.95  (2.98) -40.63  (1.46)
Week 120 (n=242, 80, 322) -42.97  (1.71) -35.00  (3.05) -40.99  (1.50)
Week 132 (n=232, 79, 311) -42.87  (1.73) -35.05  (3.13) -40.88  (1.52)
Week 144 (n=224, 76, 300) -42.48  (1.77) -33.78  (3.22) -40.27  (1.57)
Week 156 (n=219, 72, 291) -42.72  (1.71) -32.64  (3.13) -40.22  (1.52)
Week 168 (n=213, 70, 283) -43.00  (1.72) -33.61  (3.22) -40.67  (1.53)
Week 180 (n=180, 57, 237) -43.22  (1.91) -36.14  (3.72) -41.52  (1.71)
Week 192 (n=138, 42, 180) -42.05  (2.10) -34.40  (3.95) -40.27  (1.86)
Week 204 (n=109, 30, 139) -42.44  (2.36) -35.73  (5.31) -40.99  (2.18)
Week 216 (n=76, 13, 89) -42.04  (2.87) -23.92  (9.22) -39.39  (2.86)
Week 228 (n=68, 5, 73) -37.09  (2.96) -17.60  (10.66) -35.75  (2.89)
Week 240 (n=65, 5, 70) -38.91  (2.98) -18.20  (8.36) -37.43  (2.89)
Week 252 (n=65, 5, 70) -40.37  (2.92) -7.60  (9.17) -38.03  (2.95)
Week 264 (n=59, 5, 64) -37.32  (3.69) -16.20  (9.01) -35.67  (3.54)
Week 276 (n=21, 1, 22) -35.62  (6.09) -10.00 [1]   (NA) -34.45  (5.92)
Week 288 (n=3, 0, 3) -41.67  (7.31) NA [2]   (NA) -41.67  (7.31)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
9.Secondary Outcome
Title Change From Baseline in 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. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n= 378, 105, 483) -42.80  (1.13) -33.49  (2.01) -40.78  (1.00)
Week 4 (n=372, 105, 477) -46.06  (1.08) -34.91  (2.20) -43.60  (0.99)
Week 8 (n=371, 105, 476) -47.34  (1.06) -37.15  (2.00) -45.09  (0.95)
Week 12 (n=370, 105, 475) -47.78  (1.09) -36.56  (2.33) -45.30  (1.00)
Week 24 (n=357, 104, 461) -48.29  (1.07) -41.26  (2.01) -46.70  (0.95)
Week 36 (n=339, 102, 441) -49.28  (1.09) -41.92  (2.01) -47.58  (0.97)
Week 48 (n=331, 102, 433) -49.96  (1.13) -45.28  (2.08) -48.86  (1.00)
Week 60 (n=323, 102, 425) -49.89  (1.14) -47.01  (2.05) -49.20  (1.00)
Week 72 (n=315, 99, 414) -50.03  (1.14) -45.70  (1.95) -48.99  (0.99)
Week 84 (n=309, 92, 401) -50.61  (1.16) -46.89  (2.17) -49.75  (1.02)
Week 96 (n=281, 87, 368) -49.99  (1.28) -48.16  (2.23) -49.55  (1.11)
Week 108 (n=259, 83, 342) -49.62  (1.33) -47.99  (2.56) -49.22  (1.18)
Week 120 (n=242, 80, 322) -49.42  (1.47) -47.76  (2.39) -49.01  (1.26)
Week 132 (n=231, 78, 309) -49.99  (1.41) -50.19  (2.33) -50.04  (1.20)
Week 144 (n=224, 76, 300) -50.80  (1.46) -49.55  (2.44) -50.49  (1.25)
Week 156 (n=219, 72, 291) -50.68  (1.39) -49.78  (2.58) -50.46  (1.23)
Week 168 (n=213, 70, 283) -51.52  (1.45) -46.33  (2.60) -50.23  (1.27)
Week 180 (n=180, 57, 237) -52.20  (1.51) -50.33  (2.84) -51.75  (1.33)
Week 192 (n=138, 42, 180) -51.41  (1.72) -50.43  (2.98) -51.18  (1.49)
Week 204 (n=109, 30, 139) -51.10  (1.73) -50.97  (4.12) -51.07  (1.61)
Week 216 (n=76, 13, 89) -50.91  (2.01) -42.77  (6.37) -49.72  (1.96)
Week 228 (n=67, 5, 72) -49.57  (2.37) -33.60  (8.88) -48.46  (2.33)
Week 240 (n=65, 5, 70) -49.94  (2.25) -34.40  (10.30) -48.83  (2.25)
Week 252 (n=65, 5, 70) -51.78  (2.17) -31.60  (7.92) -50.34  (2.17)
Week 264 (n=58, 5, 63) -52.62  (2.36) -33.80  (9.49) -51.13  (2.36)
Week 276 (n=21, 1, 22) -53.05  (3.92) -7.00 [1]   (NA) -50.95  (4.29)
Week 288 (n=3, 0, 3) -37.67  (1.33) NA [2]   (NA) -37.67  (1.33)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
10.Secondary Outcome
Title Change From Baseline in Patient Assessment of Arthritis Pain
Hide Description Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 2 (n= 378, 105, 483) -34.23  (1.40) -27.98  (2.39) -32.87  (1.22)
Week 4 (n=372, 105, 477) -37.32  (1.38) -27.70  (2.61) -35.20  (1.23)
Week 8 (n=371, 105, 476) -39.54  (1.34) -30.69  (2.32) -37.59  (1.17)
Week 12 (n=370, 105, 475) -39.34  (1.36) -29.03  (2.25) -37.06  (1.18)
Week 24 (n=357, 104, 461) -40.70  (1.42) -33.60  (2.50) -39.10  (1.24)
Week 36 (n=339, 102, 441) -41.70  (1.45) -32.71  (2.56) -39.62  (1.27)
Week 48 (n=331, 102, 433) -41.98  (1.41) -34.39  (2.52) -40.19  (1.24)
Week 60 (n=323, 102, 425) -42.37  (1.44) -36.65  (2.36) -41.00  (1.24)
Week 72 (n=315, 99, 414) -41.84  (1.51) -37.41  (2.28) -40.79  (1.28)
Week 84 (n=309, 92, 401) -42.49  (1.53) -37.65  (2.55) -41.38  (1.32)
Week 96 (n=281, 87, 368) -42.21  (1.63) -38.21  (2.87) -41.27  (1.42)
Week 108 (n=259, 84, 343) -42.61  (1.68) -37.99  (2.87) -41.48  (1.45)
Week 120 (n=242, 80, 322) -42.44  (1.74) -37.45  (2.92) -41.20  (1.50)
Week 132 (n=232, 79, 311) -42.52  (1.78) -37.86  (3.04) -41.33  (1.54)
Week 144 (n=224, 76, 300) -42.05  (1.81) -37.07  (3.09) -40.79  (1.56)
Week 156 (n=219, 72, 291) -43.77  (1.75) -36.39  (2.89) -41.94  (1.51)
Week 168 (n=213, 70, 283) -43.87  (1.73) -37.96  (3.24) -42.41  (1.54)
Week 180 (n=180, 57, 237) -43.85  (1.92) -40.21  (3.51) -42.97  (1.68)
Week 192 (n=138, 42, 180) -42.64  (2.22) -36.67  (3.93) -41.24  (1.94)
Week 204 (n=109, 30, 139) -41.11  (2.59) -38.70  (5.25) -40.59  (2.32)
Week 216 (n=76, 13, 89) -41.61  (2.90) -30.38  (9.30) -39.97  (2.84)
Week 228 (n=68, 5, 73) -37.19  (2.96) -28.40  (12.48) -36.59  (2.87)
Week 240 (n=65, 5, 70) -36.72  (3.08) -21.20  (7.85) -35.61  (2.94)
Week 252 (n=65, 5, 70) -38.54  (3.19) -21.20  (10.56) -37.30  (3.08)
Week 264 (n=59, 5, 64) -36.80  (3.72) -16.60  (11.91) -35.22  (3.60)
Week 276 (n=21, 1, 22) -40.19  (5.00) -44.00 [1]   (NA) -40.36  (4.77)
Week 288 (n=3, 0, 3) -34.67  (9.82) NA [2]   (NA) -34.67  (9.82)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
11.Secondary Outcome
Title Change From Baseline in Tender/Painful Joint Counts
Hide Description This was carried out on 68 joints. Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Tender/painful joints
Week 2 (n=378, 105, 483) -11.88  (0.48) -10.17  (0.95) -11.51  (0.43)
Week 4 (n=373, 105, 478) -12.13  (0.51) -10.46  (0.90) -11.77  (0.45)
Week 8 (n=371, 105, 476) -13.06  (0.47) -10.75  (0.96) -12.55  (0.43)
Week 12 (n=370, 105, 475) -13.41  (0.47) -10.74  (0.97) -12.82  (0.43)
Week 24 (n=357, 104, 461) -14.02  (0.50) -12.62  (0.89) -13.70  (0.44)
Week 36 (n=339, 102, 441) -14.32  (0.53) -13.05  (0.94) -14.03  (0.46)
Week 48 (n=331, 102, 433) -14.23  (0.53) -13.43  (0.99) -14.04  (0.47)
Week 60 (n=323, 102, 425) -14.23  (0.55) -13.67  (0.94) -14.09  (0.48)
Week 72 (n=315, 99, 414) -14.45  (0.56) -14.00  (0.96) -14.34  (0.48)
Week 84 (n=309, 92, 401) -14.39  (0.56) -14.04  (1.11) -14.31  (0.50)
Week 96 (n=281, 87, 368) -14.44  (0.60) -13.92  (1.03) -14.32  (0.52)
Week 108 (n=259, 83, 342) -14.46  (0.61) -13.66  (1.14) -14.26  (0.54)
Week 120 (n=242, 80, 322) -14.67  (0.65) -13.69  (1.07) -14.42  (0.55)
Week 132 (n=232, 79, 311) -14.01  (0.73) -13.30  (1.33) -13.83  (0.64)
Week 144 (n=224, 76, 300) -14.45  (0.68) -13.83  (1.18) -14.29  (0.59)
Week 156 (n=219, 72, 291) -14.24  (0.70) -14.15  (1.20) -14.22  (0.61)
Week 168 (n=213, 70, 283) -14.41  (0.73) -14.06  (1.25) -14.33  (0.63)
Week 180 (n=180, 57, 237) -14.78  (0.79) -15.18  (1.46) -14.87  (0.70)
Week 192 (n=138, 42, 180) -15.01  (0.87) -14.57  (1.42) -14.91  (0.74)
Week 204 (n=109, 30, 139) -14.79  (0.94) -15.67  (1.93) -14.98  (0.84)
Week 216 (n=76, 13, 89) -14.42  (1.04) -11.38  (2.64) -13.98  (0.97)
Week 228 (n=68, 5, 73) -13.78  (1.56) -11.60  (5.46) -13.63  (1.49)
Week 240 (n=65, 5, 70) -15.11  (1.15) -10.80  (4.92) -14.80  (1.12)
Week 252 (n=65, 5, 70) -15.34  (1.17) -9.60  (4.55) -14.93  (1.14)
Week 264 (n=59, 5, 64) -15.54  (1.27) -9.80  (3.95) -15.09  (1.22)
Week 276 (n=22, 1, 23) -17.55  (2.55) -4.00 [1]   (NA) -16.96  (2.51)
Week 288 (n=3, 0, 3) -8.67  (1.20) NA [2]   (NA) -8.67  (1.20)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
12.Secondary Outcome
Title Change From Baseline in Swollen Joint Counts
Hide Description Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Swollen joints
Week 2 (n=378, 105, 483) -9.67  (0.38) -8.69  (0.74) -9.46  (0.34)
Week 4 (n=373, 105, 478) -10.12  (0.42) -8.54  (0.75) -9.78  (0.37)
Week 8 (n=371, 105, 476) -10.90  (0.39) -9.31  (0.73) -10.55  (0.35)
Week 12 (n=370, 105, 475) -11.18  (0.40) -9.21  (0.67) -10.74  (0.35)
Week 24 (n=357, 104, 461) -11.33  (0.40) -10.46  (0.72) -11.13  (0.35)
Week 36 (n=339, 102, 441) -11.62  (0.43) -10.75  (0.73) -11.41  (0.37)
Week 48 (n=331, 102, 433) -11.76  (0.44) -11.11  (0.74) -11.61  (0.38)
Week 60 (n=323, 102, 425) -11.83  (0.44) -10.97  (0.76) -11.62  (0.38)
Week 72 (n=315, 99, 414) -12.00  (0.46) -11.38  (0.80) -11.85  (0.40)
Week 84 (n=309, 92, 401) -12.08  (0.47) -11.72  (0.88) -12.00  (0.41)
Week 96 (n=281, 87, 368) -11.97  (0.50) -11.54  (0.84) -11.87  (0.43)
Week 108 (n=259, 83, 342) -11.94  (0.52) -11.60  (0.91) -11.86  (0.45)
Week 120 (n=242, 80, 322) -12.09  (0.56) -11.24  (0.87) -11.88  (0.47)
Week 132 (n=232, 79, 311) -11.69  (0.64) -11.15  (1.16) -11.55  (0.56)
Week 144 (n=224, 76, 300) -11.90  (0.61) -11.74  (0.94) -11.86  (0.51)
Week 156 (n=219, 72, 291) -12.07  (0.61) -11.86  (1.04) -12.02  (0.52)
Week 168 (n=213, 70, 283) -12.17  (0.62) -11.67  (1.05) -12.05  (0.54)
Week 180 (n=180, 57, 237) -12.43  (0.70) -12.26  (1.24) -12.39  (0.61)
Week 192 (n=138, 42, 180) -12.36  (0.79) -12.48  (1.47) -12.38  (0.69)
Week 204 (n=109, 30, 139) -12.35  (0.82) 12.50  (1.89) 12.38  (0.76)
Week 216 (n=76, 13, 89) -12.34  (0.99) -9.00  (2.35) -11.85  (0.91)
Week 228 (n=68, 5, 73) -11.74  (1.47) -11.00  (5.09) -11.68  (1.41)
Week 240 (n=65, 5, 70) -13.09  (1.12) -11.40  (5.48) -12.97  (1.10)
Week 252 (n=65, 5, 70) -13.20  (1.15) -10.60  (4.70) -13.01  (1.11)
Week 264 (n=59, 5, 64) -13.58  (1.24) -10.00  (4.11) -13.30  (1.19)
Week 276 (n=22, 1, 23) -15.32  (2.53) -6.00 [1]   (NA) -14.91  (2.46)
Week 288 (n=3, 0, 3) -8.33  (0.88) NA [2]   (NA) -8.33  (0.88)
[1]
Standard error was not calculated due to one participant data available.
[2]
Mean and standard error were not calculated because no data were available.
13.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 7.87  (0.45) 5.94  (0.76) 7.45  (0.39)
Week 24 (n=357, 104, 461) 8.67  (0.46) 6.12  (1.01) 8.10  (0.42)
Week 48 (n=331, 102, 433) 9.06  (0.48) 6.84  (1.05) 8.54  (0.45)
Week 72 (n=315, 99, 414) 9.10  (0.51) 7.61  (0.93) 8.74  (0.45)
Week 96 (n=281, 87, 368) 9.11  (0.55) 8.26  (0.88) 8.91  (0.47)
Week 120 (n=242, 80, 322) 9.12  (0.57) 8.34  (1.09) 8.92  (0.51)
Week 144 (n=224, 76, 300) 8.85  (0.66) 7.57  (1.18) 8.53  (0.57)
Week 168 (n=213, 70, 283) 9.01  (0.68) 7.16  (1.36) 8.55  (0.61)
Week 192 (n=138, 42, 180) 9.43  (0.78) 8.09  (1.25) 9.12  (0.66)
Week 216 (n=76, 13, 89) 8.78  (0.98) 5.04  (2.27) 8.23  (0.91)
Week 240 (n=65, 5, 70) 8.91  (1.00) 3.27  (1.90) 8.51  (0.95)
Week 264 (n=59, 5, 64) 8.85  (1.08) 1.64  (1.98) 8.28  (1.03)
Week 288 (n=3, 0, 3) 10.23  (1.18) NA [1]   (NA) 10.23  (1.18)
[1]
Mean and standard error were not calculated because no data were available.
14.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 7.31  (0.57) 5.48  (1.00) 6.90  (0.50)
Week 24 (n=357, 104, 461) 8.21  (0.59) 6.29  (1.06) 7.77  (0.51)
Week 48 (n=331, 102, 433) 8.38  (0.64) 7.77  (0.92) 8.23  (0.53)
Week 72 (n=315, 99, 414) 7.23  (0.67) 7.47  (1.08) 7.29  (0.57)
Week 96 (n=281, 87, 368) 7.24  (0.70) 8.15  (1.16) 7.46  (0.60)
Week 120 (n=242, 80, 322) 7.69  (0.75) 6.77  (1.10) 7.46  (0.63)
Week 144 (n=224, 76, 300) 7.21  (0.80) 6.56  (1.23) 7.05  (0.67)
Week 168 (n=213, 70, 283) 7.38  (0.77) 5.42  (1.41) 6.90  (0.68)
Week 192 (n=138, 42, 180) 6.59  (1.01) 6.70  (1.57) 6.61  (0.86)
Week 216 (n=76, 13, 89) 6.53  (1.37) 4.59  (2.53) 6.25  (1.22)
Week 240 (n=65, 5, 70) 6.13  (1.56) -0.48  (2.86) 5.66  (1.48)
Week 264 (n=59, 5, 64) 6.15  (1.58) 0.95  (2.68) 5.74  (1.48)
Week 288 (n=3, 0, 3) 22.27  (5.22) NA [1]   (NA) 22.27  (5.22)
[1]
Mean and standard error were not calculated because no data were available.
15.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 11.40  (0.48) 8.13  (0.77) 10.40  (0.41)
Week 24 (n=357, 104, 461) 11.87  (0.50) 9.63  (0.79) 11.36  (0.43)
Week 48 (n=331, 102, 433) 12.19  (0.53) 10.65  (0.75) 11.83  (0.44)
Week 72 (n=315, 99, 414) 11.96  (0.56) 9.92  (0.81) 11.47  (0.47)
Week 96 (n=281, 87, 368) 11.35  (0.59) 11.60  (1.04) 11.41  (0.51)
Week 120 (n=242, 80, 322) 11.98  (0.62) 10.42  (1.08) 11.60  (0.54)
Week 144 (n=224, 76, 300) 11.51  (0.68) 11.15  (1.04) 11.42  (0.57)
Week 168 (n=213, 70, 283) 11.82  (0.65) 11.07  (1.11) 11.63  (0.56)
Week 192 (n=138, 42, 180) 11.19  (0.85) 11.43  (1.57) 11.25  (0.75)
Week 216 (n=76, 13, 89) 12.43  (1.03) 8.52  (2.37) 11.86  (0.95)
Week 240 (n=65, 5, 70) 11.34  (1.04) 5.25  (2.63) 10.90  (0.99)
Week 264 (n=59, 5, 64) 11.27  (1.28) 4.50  (2.87) 10.74  (1.22)
Week 288 (n=3, 0, 3) 7.08  (5.60) NA [1]   (NA) 7.08  (5.60)
[1]
Mean and standard error were not calculated because no data were available.
16.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 6.07  (0.38) 4.24  (0.70) 5.67  (0.34)
Week 24 (n=357, 104, 461) 6.38  (0.39) 5.00  (0.58) 6.07  (0.33)
Week 48 (n=331, 102, 433) 6.40  (0.40) 5.20  (0.67) 6.12  (0.34)
Week 72 (n=315, 99, 414) 6.29  (0.42) 5.35  (0.63) 6.06  (0.35)
Week 96 (n=281, 87, 368) 6.00  (0.45) 4.82  (0.73) 5.72  (0.38)
Week 120 (n=242, 80, 322) 5.86  (0.49) 5.36  (0.82) 5.74  (0.42)
Week 144 (n=224, 76, 300) 5.37  (0.54) 4.38  (0.94) 5.12  (0.47)
Week 168 (n=213, 70, 283) 5.82  (0.53) 3.93  (0.87) 5.35  (0.46)
Week 192 (n=138, 42, 180) 4.72  (0.61) 4.10  (1.05) 4.57  (0.53)
Week 216 (n=76, 13, 89) 3.73  (0.87) 1.59  (1.31) 3.42  (0.77)
Week 240 (n=65, 5, 70) 4.39  (0.96) -1.50  (1.90) 3.97  (0.92)
Week 264 (n=59, 5, 64) 4.12  (1.01) -1.03  (2.17) 3.72  (0.96)
Week 288 (n=3, 0, 3) -0.94  (4.23) NA [1]   (NA) -0.94  (4.23)
[1]
Mean and standard error were not calculated because no data were available.
17.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 7.37  (0.59) 6.61  (0.90) 7.20  (0.50)
Week 24 (n=357, 104, 461) 7.24  (0.58) 6.25  (0.97) 7.02  (0.50)
Week 48 (n=331, 102, 433) 6.83  (0.58) 7.22  (0.89) 6.92  (0.49)
Week 72 (n=315, 99, 414) 7.02  (0.61) 6.44  (0.98) 6.88  (0.52)
Week 96 (n=281, 87, 368) 6.78  (0.61) 6.19  (1.11) 6.64  (0.54)
Week 120 (n=242, 80, 322) 6.49  (0.70) 6.96  (1.26) 6.61  (0.61)
Week 144 (n=224, 76, 300) 6.27  (0.75) 5.51  (1.15) 6.08  (0.63)
Week 168 (n=213, 70, 283) 6.58  (0.72) 4.75  (1.27) 6.12  (0.63)
Week 192 (n=138, 42, 180) 5.40  (0.92) 5.70  (1.62) 5.47  (0.80)
Week 216 (n=76, 13, 89) 5.04  (1.18) 5.30  (2.47) 5.08  (1.07)
Week 240 (n=65, 5, 70) 5.11  (1.21) -0.60  (3.05) 4.70  (1.15)
Week 264 (n=59, 5, 64) 4.72  (1.17) -1.80  (3.36) 4.21  (1.13)
Week 288 (n=3, 0, 3) 14.97  (8.64) NA [1]   (NA) 14.97  (8.64)
[1]
Mean and standard error were not calculated because no data were available.
18.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 4.99  (0.60) 5.17  (1.09) 5.03  (0.52)
Week 24 (n=357, 104, 461) 5.57  (0.62) 4.96  (1.25) 5.44  (0.56)
Week 48 (n=331, 102, 433) 5.28  (0.64) 5.27  (1.14) 5.28  (0.55)
Week 72 (n=315, 99, 414) 4.81  (0.64) 4.78  (1.31) 4.81  (0.58)
Week 96 (n=281, 87, 368) 4.88  (0.67) 6.43  (1.19) 5.25  (0.58)
Week 120 (n=242, 80, 322) 5.20  (0.76) 5.98  (1.11) 5.39  (0.63)
Week 144 (n=224, 76, 300) 5.23  (0.77) 3.33  (1.39) 4.75  (0.67)
Week 168 (n=213, 70, 283) 4.72  (0.79) 3.84  (1.43) 4.50  (0.69)
Week 192 (n=138, 42, 180) 4.56  (0.96) 5.63  (1.36) 4.81  (0.80)
Week 216 (n=76, 13, 89) 4.53  (1.23) 3.31  (2.48) 4.35  (1.10)
Week 240 (n=65, 5, 70) 4.88  (1.41) 0.00  (0.00) 4.53  (1.32)
Week 264 (n=59, 5, 64) 4.47  (1.45) -2.15  (2.15) 3.95  (1.37)
Week 288 (n=3, 0, 3) 14.34  (9.49) NA [1]   (NA) 14.34  (9.49)
[1]
Mean and standard error were not calculated because no data were available.
19.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 6.65  (0.65) 4.98  (1.19) 6.28  (0.57)
Week 24 (n=357, 104, 461) 6.88  (0.73) 4.40  (1.41) 6.32  (0.65)
Week 48 (n=331, 102, 433) 7.26  (0.75) 5.49  (1.29) 6.85  (0.65)
Week 72 (n=315, 99, 414) 6.02  (0.78) 5.54  (1.28) 5.91  (0.67)
Week 96 (n=281, 87, 368) 6.04  (0.79) 5.96  (1.43) 6.02  (0.69)
Week 120 (n=242, 80, 322) 5.68  (0.90) 3.98  (1.40) 5.26  (0.76)
Week 144 (n=224, 76, 300) 5.39  (0.96) 3.74  (1.56) 4.97  (0.82)
Week 168 (n=213, 70, 283) 5.90  (0.89) 4.43  (1.49) 5.54  (0.76)
Week 192 (n=138, 42, 180) 4.31  (1.23) 4.42  (1.91) 4.33  (1.04)
Week 216 (n=76, 13, 89) 4.33  (1.55) 3.49  (2.76) 4.21  (1.38)
Week 240 (n=65, 5, 70) 4.72  (1.66) -0.76  (4.22) 4.33  (1.58)
Week 264 (n=59, 5, 64) 5.07  (1.74) -0.76  (4.22) 4.61  (1.64)
Week 288 (n=3, 0, 3) 22.71  (5.78) NA [1]   (NA) 22.71  (5.78)
[1]
Mean and standard error were not calculated because no data were available.
20.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 6.27  (0.63) 5.38  (1.04) 6.08  (0.54)
Week 24 (n=357, 104, 461) 6.22  (0.65) 3.84  (1.17) 5.69  (0.57)
Week 48 (n=331, 102, 433) 5.73  (0.64) 5.35  (1.02) 5.64  (0.54)
Week 72 (n=315, 99, 414) 4.77  (0.70) 5.48  (1.04) 4.94  (0.59)
Week 96 (n=281, 87, 368) 5.23  (0.68) 5.89  (1.14) 5.38  (0.59)
Week 120 (n=242, 80, 322) 5.56  (0.77) 5.26  (1.31) 5.49  (0.67)
Week 144 (n=224, 76, 300) 5.10  (0.84) 4.37  (1.34) 4.91  (0.71)
Week 168 (n=213, 70, 283) 5.12  (0.76) 3.76  (1.29) 4.79  (0.66)
Week 192 (n=138, 42, 180) 3.77  (0.93) 5.21  (1.75) 4.11  (0.82)
Week 216 (n=76, 13, 89) 2.66  (1.21) 4.26  (3.04) 2.89  (1.12)
Week 240 (n=65, 5, 70) 3.75  (1.20) 3.32  (2.04) 3.72  (1.12)
Week 264 (n=59, 5, 64) 4.18  (1.34) 0.00  (1.75) 3.85  (1.25)
Week 288 (n=3, 0, 3) 14.78  (7.56) NA [1]   (NA) 14.78  (7.56)
[1]
Mean and standard error were not calculated because no data were available.
21.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 8.44  (0.39) 6.09  (0.68) 7.92  (0.34)
Week 24 (n=357, 104, 461) 9.39  (0.38) 7.56  (0.70) 8.98  (0.34)
Week 48 (n=331, 102, 433) 9.75  (0.43) 8.24  (0.72) 9.39  (0.37)
Week 72 (n=315, 99, 414) 9.72  (0.43) 8.21  (0.76) 9.36  (0.37)
Week 96 (n=281, 87, 368) 9.35  (0.48) 8.93  (0.77) 9.25  (0.41)
Week 120 (n=242, 80, 322) 9.66  (0.49) 8.79  (0.92) 9.45  (0.43)
Week 144 (n=224, 76, 300) 9.26  (0.54) 8.60  (0.92) 9.09  (0.47)
Week 168 (n=213, 70, 283) 9.51  (0.54) 7.86  (1.03) 9.10  (0.48)
Week 192 (n=138, 42, 180) 9.51  (0.65) 8.56  (1.18) 9.29  (0.57)
Week 216 (n=76, 13, 89) 9.59  (0.88) 5.37  (1.93) 8.97  (0.82)
Week 240 (n=65, 5, 70) 9.00  (0.93) 1.91  (2.87) 8.49  (0.91)
Week 264 (n=59, 5, 64) 8.72  (1.03) 2.31  (2.27) 8.22  (0.99)
Week 288 (n=3, 0, 3) 6.87  (1.88) NA [1]   (NA) 6.87  (1.88)
[1]
Mean and standard error were not calculated because no data were available.
22.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and 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) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).
Time Frame Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 381 105 486
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 (n=370, 105, 475) 5.13  (0.63) 4.82  (1.01) 5.06  (0.54)
Week 24 (n=357, 104, 461) 4.95  (0.67) 3.38  (1.26) 4.60  (0.59)
Week 48 (n=331, 102, 433) 4.56  (0.66) 4.45  (1.06) 4.54  (0.56)
Week 72 (n=315, 99, 414) 3.63  (0.69) 4.15  (1.14) 3.75  (0.59)
Week 96 (n=281, 87, 368) 3.88  (0.68) 4.53  (1.25) 4.03  (0.60)
Week 120 (n=242, 80, 322) 3.79  (0.80) 3.68  (1.37) 3.76  (0.69)
Week 144 (n=224, 76, 300) 3.57  (0.84) 2.24  (1.40) 3.23  (0.72)
Week 168 (n=213, 70, 283) 3.64  (0.80) 2.45  (1.41) 3.35  (0.70)
Week 192 (n=138, 42, 180) 2.05  (0.99) 3.44  (1.80) 2.38  (0.86)
Week 216 (n=76, 13, 89) 1.49  (1.29) 3.14  (3.04) 1.73  (1.18)
Week 240 (n=65, 5, 70) 2.41  (1.27) -0.04  (1.81) 2.23  (1.19)
Week 264 (n=59, 5, 64) 2.59  (1.42) -2.25  (1.41) 2.21  (1.32)
Week 288 (n=3, 0, 3) 18.64  (4.01) NA [1]   (NA) 18.64  (4.01)
[1]
Mean and standard error were not calculated because no data were available.
23.Secondary Outcome
Title Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)
Hide Description mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study.
Time Frame First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had completed Study A3921044 among all participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description:
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
Overall Number of Participants Analyzed 75 7 82
Mean (Standard Error)
Unit of Measure: Units on a scale
Week 24 (n=69, 7, 76) 0.17  (0.09) 0.50  (0.22) 0.20  (0.08)
Week 48 (n=64, 7, 71) 0.27  (0.17) 1.75  (1.16) 0.41  (0.19)
Week 96 (n=39, 1, 40) 0.40  (0.21) 1.00 [1]   (NA) 0.42  (0.20)
[1]
Standard error was not calculated because there was one participant data.
Time Frame Safety observations up to Week 288
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Hide Arm/Group Description CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
All-Cause Mortality
CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   111/381 (29.13%)   28/105 (26.67%)   139/486 (28.60%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Disseminated intravascular coagulation * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Thrombotic thrombocytopenic purpura * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Cardiac disorders       
Acute coronary syndrome * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Angina pectoris * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Prinzmetal angina * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Ventricular fibrillation * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Ear and labyrinth disorders       
Vertigo * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Vertigo positional * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Endocrine disorders       
Hyperparathyroidism primary * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Eye disorders       
Cataract * 1  2/381 (0.52%)  1/105 (0.95%)  3/486 (0.62%) 
Dacryostenosis acquired * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Retinal artery occlusion * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Retinal detachment * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Gastrointestinal disorders       
Colitis ischaemic * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Gastric polyps * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Gastric ulcer haemorrhage * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Ileus * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Inguinal hernia * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Large intestine polyp * 1  3/381 (0.79%)  0/105 (0.00%)  3/486 (0.62%) 
Radicular cyst * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
General disorders       
Chest pain * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Device material issue * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Submandibular mass * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Hepatobiliary disorders       
Cholecystitis chronic * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Cholelithiasis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Liver disorder * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Infections and infestations       
Appendicitis * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Bronchitis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Cellulitis * 1  3/381 (0.79%)  1/105 (0.95%)  4/486 (0.82%) 
Chronic sinusitis * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Diverticulitis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Enteritis infectious * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Enterocolitis infectious * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Enterocolitis viral * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Gastroenteritis * 1  2/381 (0.52%)  1/105 (0.95%)  3/486 (0.62%) 
Herpes zoster * 1  11/381 (2.89%)  2/105 (1.90%)  13/486 (2.67%) 
Herpes zoster disseminated * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Mycobacterium avium complex infection * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Nasopharyngitis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Pneumocystis jirovecii pneumonia * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Pneumonia * 1  6/381 (1.57%)  1/105 (0.95%)  7/486 (1.44%) 
Pneumonia bacterial * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Pneumonia haemophilus * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Pneumonia mycoplasmal * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Pulmonary tuberculosis * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Pyelonephritis * 1  3/381 (0.79%)  2/105 (1.90%)  5/486 (1.03%) 
Sepsis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Septic shock * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Urinary tract infection * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Injury, poisoning and procedural complications       
Ankle fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Compression fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Contusion * 1  3/381 (0.79%)  0/105 (0.00%)  3/486 (0.62%) 
Femoral neck fracture * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Femur fracture * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Hand fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Humerus fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Joint dislocation * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Patella fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Post procedural haemorrhage * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Pubis fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Radius fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Tendon rupture * 1  9/381 (2.36%)  0/105 (0.00%)  9/486 (1.85%) 
Tibia fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Ulna fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Upper limb fracture * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Investigations       
Alanine aminotransferase increased * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Computerised tomogram thorax abnormal * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Hypokalaemia * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Musculoskeletal and connective tissue disorders       
Arthropathy * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Foot deformity * 1  1/381 (0.26%)  1/105 (0.95%)  2/486 (0.41%) 
Intervertebral disc protrusion * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Joint destruction * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Kyphosis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Lumbar spinal stenosis * 1  0/381 (0.00%)  4/105 (3.81%)  4/486 (0.82%) 
Neck pain * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Osteoarthritis * 1  2/381 (0.52%)  1/105 (0.95%)  3/486 (0.62%) 
Osteonecrosis * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Periostitis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Rheumatoid arthritis * 1  3/381 (0.79%)  1/105 (0.95%)  4/486 (0.82%) 
Spinal column stenosis * 1  3/381 (0.79%)  0/105 (0.00%)  3/486 (0.62%) 
Spondylolisthesis * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute myeloid leukaemia * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Adenocarcinoma gastric * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Breast cancer * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Colon adenoma * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Colon cancer * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Colorectal adenocarcinoma * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Fallopian tube cancer * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Gastric cancer * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Haemangioma * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Liposarcoma * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Lymphoproliferative disorder * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Malignant ascites * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Malignant pleural effusion * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Metastases to liver * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Metastases to lung * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Metastases to lymph nodes * 1  3/381 (0.79%)  0/105 (0.00%)  3/486 (0.62%) 
Metastases to peritoneum * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Neuroendocrine carcinoma of the skin * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Oesophageal carcinoma * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Ovarian cancer * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Ovarian cancer metastatic * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Ovarian germ cell teratoma benign * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Paget's disease of nipple * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Peritoneal neoplasm * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Small cell lung cancer * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Squamous cell carcinoma of lung * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Transitional cell carcinoma * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Uterine leiomyoma * 1  2/381 (0.52%)  0/105 (0.00%)  2/486 (0.41%) 
Nervous system disorders       
Carpal tunnel syndrome * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Cerebral haemorrhage * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Cerebral infarction * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Cerebral thrombosis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Convulsion * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Cubital tunnel syndrome * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
IIIrd nerve paralysis * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Lacunar infarction * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
Loss of consciousness * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Spondylitic myelopathy * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Temporal lobe epilepsy * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Transient global amnesia * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Renal and urinary disorders       
Calculus ureteric * 1  1/381 (0.26%)  1/105 (0.95%)  2/486 (0.41%) 
Glomerulonephritis membranous * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Reproductive system and breast disorders       
Uterine polyp * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Interstitial lung disease * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Organising pneumonia * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Pleurisy * 1  1/381 (0.26%)  0/105 (0.00%)  1/486 (0.21%) 
Skin and subcutaneous tissue disorders       
Skin ulcer * 1  0/381 (0.00%)  1/105 (0.95%)  1/486 (0.21%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CP-690,550 5 mg BID CP-690,550 10 mg BID Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   345/381 (90.55%)   101/105 (96.19%)   446/486 (91.77%) 
Blood and lymphatic system disorders       
Anaemia * 1  14/381 (3.67%)  11/105 (10.48%)  25/486 (5.14%) 
Eye disorders       
Conjunctivitis * 1  17/381 (4.46%)  6/105 (5.71%)  23/486 (4.73%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  13/381 (3.41%)  6/105 (5.71%)  19/486 (3.91%) 
Constipation * 1  34/381 (8.92%)  9/105 (8.57%)  43/486 (8.85%) 
Dental caries * 1  39/381 (10.24%)  15/105 (14.29%)  54/486 (11.11%) 
Diarrhoea * 1  28/381 (7.35%)  5/105 (4.76%)  33/486 (6.79%) 
Gastritis * 1  22/381 (5.77%)  4/105 (3.81%)  26/486 (5.35%) 
Stomatitis * 1  25/381 (6.56%)  7/105 (6.67%)  32/486 (6.58%) 
General disorders       
Pyrexia * 1  15/381 (3.94%)  9/105 (8.57%)  24/486 (4.94%) 
Infections and infestations       
Bronchitis * 1  45/381 (11.81%)  5/105 (4.76%)  50/486 (10.29%) 
Cystitis * 1  39/381 (10.24%)  7/105 (6.67%)  46/486 (9.47%) 
Gastroenteritis * 1  34/381 (8.92%)  11/105 (10.48%)  45/486 (9.26%) 
Gingivitis * 1  10/381 (2.62%)  7/105 (6.67%)  17/486 (3.50%) 
Herpes zoster * 1  59/381 (15.49%)  22/105 (20.95%)  81/486 (16.67%) 
Influenza * 1  37/381 (9.71%)  11/105 (10.48%)  48/486 (9.88%) 
Nasopharyngitis * 1  221/381 (58.01%)  72/105 (68.57%)  293/486 (60.29%) 
Oral herpes * 1  26/381 (6.82%)  7/105 (6.67%)  33/486 (6.79%) 
Periodontitis * 1  20/381 (5.25%)  3/105 (2.86%)  23/486 (4.73%) 
Pharyngitis * 1  36/381 (9.45%)  10/105 (9.52%)  46/486 (9.47%) 
Tinea pedis * 1  31/381 (8.14%)  3/105 (2.86%)  34/486 (7.00%) 
Upper respiratory tract infection * 1  40/381 (10.50%)  8/105 (7.62%)  48/486 (9.88%) 
Injury, poisoning and procedural complications       
Contusion * 1  36/381 (9.45%)  12/105 (11.43%)  48/486 (9.88%) 
Fall * 1  51/381 (13.39%)  20/105 (19.05%)  71/486 (14.61%) 
Ligament sprain * 1  11/381 (2.89%)  9/105 (8.57%)  20/486 (4.12%) 
Road traffic accident * 1  9/381 (2.36%)  8/105 (7.62%)  17/486 (3.50%) 
Investigations       
Alanine aminotransferase increased * 1  25/381 (6.56%)  1/105 (0.95%)  26/486 (5.35%) 
Aspartate aminotransferase increased * 1  22/381 (5.77%)  1/105 (0.95%)  23/486 (4.73%) 
Blood cholesterol increased * 1  9/381 (2.36%)  6/105 (5.71%)  15/486 (3.09%) 
Low density lipoprotein increased * 1  17/381 (4.46%)  6/105 (5.71%)  23/486 (4.73%) 
Lymphocyte count decreased * 1  29/381 (7.61%)  9/105 (8.57%)  38/486 (7.82%) 
White blood cell count decreased * 1  17/381 (4.46%)  10/105 (9.52%)  27/486 (5.56%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia * 1  13/381 (3.41%)  6/105 (5.71%)  19/486 (3.91%) 
Hyperlipidaemia * 1  36/381 (9.45%)  20/105 (19.05%)  56/486 (11.52%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  43/381 (11.29%)  3/105 (2.86%)  46/486 (9.47%) 
Rheumatoid arthritis * 1  6/381 (1.57%)  7/105 (6.67%)  13/486 (2.67%) 
Nervous system disorders       
Headache * 1  38/381 (9.97%)  10/105 (9.52%)  48/486 (9.88%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  24/381 (6.30%)  9/105 (8.57%)  33/486 (6.79%) 
Oropharyngeal pain * 1  19/381 (4.99%)  4/105 (3.81%)  23/486 (4.73%) 
Upper respiratory tract inflammation * 1  25/381 (6.56%)  9/105 (8.57%)  34/486 (7.00%) 
Skin and subcutaneous tissue disorders       
Eczema * 1  25/381 (6.56%)  2/105 (1.90%)  27/486 (5.56%) 
Rash * 1  17/381 (4.46%)  6/105 (5.71%)  23/486 (4.73%) 
Vascular disorders       
Hypertension * 1  40/381 (10.50%)  15/105 (14.29%)  55/486 (11.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
[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: NCT00661661    
Other Study ID Numbers: A3921041
First Submitted: February 7, 2008
First Posted: April 18, 2008
Results First Submitted: February 17, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015