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The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-690,550 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 | Drug | 5 mg BID up to 10 mg BID until launch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Baseline up to Week 288 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Nagoya University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41448717 | Derived | Strand V, Schulze-Koops H, Al-Emadi S, Kinch CD, Gruben D, Germino R, Connell CA, Mysler E. Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials. BMJ Open. 2025 Dec 24;15(12):e082366. doi: 10.1136/bmjopen-2023-082366. | |
| 38883150 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | 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). | 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 |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | 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). | 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 |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | 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). | 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 |
| Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | 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). | 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 |
| Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | 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). | 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 |
| Change From Baseline in Patient Global Assessment of Arthritis | 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). | 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 |
| Change From Baseline in Physician Global Assessment of Arthritis | 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). | 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 |
| Change From Baseline in Patient Assessment of Arthritis Pain | 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). | 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 |
| Change From Baseline in Tender/Painful Joint Counts | 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). | 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 |
| Change From Baseline in Swollen Joint Counts | 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). | 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 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | 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). | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
| Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | 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. | First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96 |
| Nagoya |
| Aichi-ken |
| 466-8560 |
| Japan |
| National Hospital Organization Chiba-East Hospital | Chiba | Chiba | 260-8712 | Japan |
| Chiba-ken Saiseikai Narashino Hospital | Narashino | Chiba | 275-8580 | Japan |
| Shimoshizu National Hospital | Yotukaidou | Chiba | 284-0003 | Japan |
| Kondo clinic for rheumatism and orthopaedics | Fukuoka | Fukuoka | 810-0001 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | Fukuoka | 810-8563 | Japan |
| Medical Co.LTA PS Clinic | Fukuoka | Fukuoka | 812-0025 | Japan |
| Aso Iizuka Hospital | Iiduka | Fukuoka | 820-8505 | Japan |
| University of Occupational and Environmental Health Hospital | Kitakyushu | Fukuoka | 807-8555 | Japan |
| St. Mary's Hospital | Kurume | Fukuoka | 830-8543 | Japan |
| SHONO Rheumatism Clinic | Sawara-ku | Fukuoka | 814-0002 | Japan |
| Fukusima Daiichi Hospital | Fukushima | Fukushima | 960-8251 | Japan |
| Inoue Hospital | Takasaki | Gunma | 370-0053 | Japan |
| Higashihiroshima Memorial Hospital | Higashihiroshima | Hiroshima | 739-0002 | Japan |
| Hiroshima Rheumatology Clinic | Hiroshima | Hiroshima | 730-0017 | Japan |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima | Hiroshima | 730-8619 | Japan |
| Katayama Orthopedic Rheumatology Clinic | Asahikawa | Hokkaido | 078-8243 | Japan |
| Sapporo city general hospital | Sapporo | Hokkaido | 060-8604 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Hokkaido Medical Center for Rheumatic Diseases | Sapporo | Hokkaido | 063-0811 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Taga General Hospital | Hitachi-shi | Ibaraki | 316-0035 | Japan |
| Tsukuba University Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Keio University Hospital | Shinjuku-ku, Tokyo | Japan | 160-8582 | Japan |
| National Hospital Organization Sagamihara National Hospital | Sagamihara | Kanagawa | 252-0392 | Japan |
| Kumamoto Saishunso National Hospital | Koushi | Kumamoto | 861-1196 | Japan |
| Kumamoto Orthopaedic Hospital | Kumamoto | Kumamoto | 862-0976 | Japan |
| University Hospital, Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| National hospital Organization Mie Chuou Medical Center | Tsu | Mie-ken | 514-1101 | Japan |
| Hikarigaoka Spellman Hospital | Sendai | Miyagi | 983-0833 | Japan |
| Nagasaki University Hospital of Medicine and Dentistry | Nagasaki | Nagasaki | 852-8501 | Japan |
| National Hospital Organization Nagasaki Medical Center | Ohmura | Nagasaki | 856-0835 | Japan |
| Sasebo Chuo Hospital | Sasebo | Nagasaki | 857-1195 | Japan |
| Higami hospital | Kashihara | Nara | 634-0007 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | Niigata | 951-8520 | Japan |
| A Medical Corporation Oribe Rheumatism Internist Clinic | Ōita | Oita Prefecture | 870-0823 | Japan |
| National Hospital Organization Osaka Minami Center | Kawachi-Nagano | Osaka | 586-8521 | Japan |
| The Tazuke Kofukai Medical Research Institute Kitano Hospital | Osaka | Osaka | 530-8480 | Japan |
| Ureshino Medical Center | Ureshino | Saga-ken | 843-0393 | Japan |
| Saitama Medical Center | Kawagoe-shi | Saitama | 350-8550 | Japan |
| Kitasato University Kitasato Institute Medical Center Hospital | Kitamoto | Saitama | 364-8501 | Japan |
| Saitama city hospital | Saitama | Saitama | 336-8522 | Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | 430-8558 | Japan |
| Tokyo Women's Medical University Medical Center East | Arakawa-ku | Tokyo | 116-8567 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Tokyo Medical And Dental University Hospital, Faculty of Medicine | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| The University of Tokyo Hospital | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Sasaki Foundation Kyoundo Hospital | Chiyoda-ku | Tokyo | 101-0062 | Japan |
| Juntendo Tokyo Koto Geriatric Medical Center | Koto-ku | Tokyo | 136-0075 | Japan |
| National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo | 152-8902 | Japan |
| National Hospital Organization MURAYAMA Medical Center | Musashimurayama-shi | Tokyo | 208-0011 | Japan |
| Fukuhara Hospital | Setagaya-ku | Tokyo | 155-0031 | Japan |
| Tokyo Women's Medical University, Institute of Rheumatology | Shinjyuku-ku | Tokyo | 162-0054 | Japan |
| Sendai Taihaku Hospital | Miyagi | 982-0032 | Japan |
| Pope J, Finckh A, Silva-Fernandez L, Mandl P, Fan H, Rivas JL, Valderrama M, Montoro M. Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention. Open Access Rheumatol. 2024 Jun 11;16:115-126. doi: 10.2147/OARRR.S446431. eCollection 2024. |
| 38854417 | Derived | Curtis JR, Wollenhaupt J, Tas SW, Chatzidionysiou K, Wang L, Roberts K, Tsekouras V. Determinants of tofacitinib discontinuation in adult patients with rheumatoid arthritis during long-term extension studies up to 9.5 years. Rheumatol Adv Pract. 2024 May 11;8(2):rkae063. doi: 10.1093/rap/rkae063. eCollection 2024. |
| 37453736 | Derived | Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print. |
| 36931693 | Derived | Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17. |
| 36601090 | Derived | Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022. |
| 36600185 | Derived | Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5. |
| 36526796 | Derived | Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17. |
| 34870800 | Derived | Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6. |
| 33127856 | Derived | Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395. |
| 33057725 | Derived | van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476. |
| 32816215 | Derived | Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. |
| 29435359 | Derived | Fleischmann R, Wollenhaupt J, Takiya L, Maniccia A, Kwok K, Wang L, van Vollenhoven RF. Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. RMD Open. 2017 Dec 18;3(2):e000491. doi: 10.1136/rmdopen-2017-000491. eCollection 2017. |
| 29417430 | Derived | Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7. |
| 28143815 | Derived | Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31. |
| 26818974 | Derived | Yamanaka H, Tanaka Y, Takeuchi T, Sugiyama N, Yuasa H, Toyoizumi S, Morishima Y, Hirose T, Zwillich S. Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study. Arthritis Res Ther. 2016 Jan 28;18:34. doi: 10.1186/s13075-016-0932-2. |
| 25047021 | Derived | Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779. |
| FG001 | CP-690,550 10 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. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. |
| BG001 | CP-690,550 10 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Number | Percentage of participants | 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 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Number | Percentage of participants | 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 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Number | Percentage of participants | 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 |
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| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | 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 |
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| Secondary | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | 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 |
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| Secondary | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | 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 |
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| Secondary | Change From Baseline in Patient Global Assessment of Arthritis | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | 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 |
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| Secondary | Change From Baseline in Physician Global Assessment of Arthritis | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | 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 |
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| Secondary | Change From Baseline in Patient Assessment of Arthritis Pain | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | 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 |
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| Secondary | Change From Baseline in Tender/Painful Joint Counts | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Tender/painful joints | 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 |
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| Secondary | Change From Baseline in Swollen Joint Counts | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Swollen joints | 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 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental | 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). | Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). | Posted | Mean | Standard Error | Units on a scale | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
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| Secondary | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) | 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. | 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). | Posted | Mean | Standard Error | Units on a scale | First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96 |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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. | Safety analysis set: all participants who received at least 1 dose of study medication in current study. | Posted | Number | Particiants | Baseline up to Week 288 |
|
Safety observations up to Week 288
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | 111 | 381 | 345 | 381 | ||
| EG001 | CP-690,550 10 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. | 28 | 105 | 101 | 105 | ||
| EG002 | Total | 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. | 139 | 486 | 446 | 486 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperparathyroidism primary | Endocrine disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Radicular cyst | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Device material issue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Submandibular mass | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Computerised tomogram thorax abnormal | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fallopian tube cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Paget's disease of nipple | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cerebral thrombosis | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cubital tunnel syndrome | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Spondylitic myelopathy | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Temporal lobe epilepsy | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
| Male |
|
|
| Week 8 (n=371, 105, 476) |
|
| Week 12 (n=370, 105, 475) |
|
| Week 24 (n=357, 104, 461) |
|
| Week 36 (n=339, 102, 441) |
|
| Week 48 (n=331, 102, 433) |
|
| Week 60 (n=323, 102, 425) |
|
| Week 72 (n=315, 99, 414) |
|
| Week 84 (n=309, 92, 401) |
|
| Week 96 (n=281, 87, 368) |
|
| Week 108 (n=259, 84, 343) |
|
| Week 120 (n=242, 80, 322) |
|
| Week 132 (n=232, 79, 311) |
|
| Week 144 (n=224, 76, 300) |
|
| Week 156 (n=219, 73, 292) |
|
| Week 168 (n=213, 70, 283) |
|
| Week 180 (n=180, 57, 237) |
|
| Week 192 (n=138, 42, 180) |
|
| Week 204 (n=109, 30, 139) |
|
| Week 216 (n=76, 13, 89) |
|
| Week 228 (n=68, 5, 73) |
|
| Week 240 (n=65, 5, 70) |
|
| Week 252 (n=65, 5, 70) |
|
| Week 264 (n=59, 5, 64) |
|
| Week 276 (n=22, 1, 23) |
|
| Week 288 (n=3, 0, 3) |
|
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. |
| OG002 | Total | 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. |
|
|
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. |
| OG002 | Total | 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. |
|
|
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. |
| OG002 | Total | 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. |
|
|
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. |
| OG002 | Total | 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. |
|
|
| OG002 | Total | 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. |
|
|
| OG002 | Total | 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. |
|
|
| OG002 | Total | 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. |
|
|
| OG002 | Total | 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. |
|
|
| OG002 | Total | 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. |
|
|
| OG002 | Total | 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. |
|
|
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. |
| OG002 | Total | 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. |
|
|
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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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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. |
| OG002 | Total | 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. |
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| OG002 | Total | 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. |
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| OG002 | Total | 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. |
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