Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00661661
Collaborator
(none)
487
56
1
68
8.7
0.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
487 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis
Study Start Date
:
Apr 1, 2008
Actual Primary Completion Date
:
Dec 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CP-690,550
|
Drug: CP-690,550
5 mg BID up to 10 mg BID until launch
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Baseline up to Week 288]
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.
Secondary Outcome Measures
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [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]
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).
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [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]
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).
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [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]
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).
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [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]
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).
- Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [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]
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).
- Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [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]
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).
- Change From Baseline in Patient Global Assessment of Arthritis [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]
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).
- Change From Baseline in Physician Global Assessment of Arthritis [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]
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).
- Change From Baseline in Patient Assessment of Arthritis Pain [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]
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).
- Change From Baseline in Tender/Painful Joint Counts [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]
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).
- Change From Baseline in Swollen Joint Counts [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]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental [Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288]
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).
- Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) [First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis
Exclusion Criteria:
- Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National hospital Organization Nagoya Medical Center | Nagoya | Aichi | Japan | 460-0001 |
| 2 | Nagoya University Hospital | Nagoya | Aichi | Japan | 466-8560 |
| 3 | Chiba-ken Saiseikai Narashino Hospital | Narashino | Chiba | Japan | 275-8580 |
| 4 | Shimoshizu National Hospital | Yotukaidou | Chiba | Japan | 284-0003 |
| 5 | Aso Iizuka Hospital | Iiduka | Fukuoka | Japan | 820-8505 |
| 6 | University of Occupational and Environmental Health Hospital | Kitakyusyu | Fukuoka | Japan | 807-8555 |
| 7 | St. Mary's Hospital | Kurume | Fukuoka | Japan | 830-8543 |
| 8 | SHONO Rheumatism Clinic | Sawara-ku | Fukuoka | Japan | 814-0002 |
| 9 | Inoue Hospital | Takasaki | Gunma | Japan | 370-0053 |
| 10 | Higashihiroshima Memorial Hospital | Higashihiroshima | Hiroshima | Japan | 739-0002 |
| 11 | Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima-city | Hiroshima | Japan | 730-8619 |
| 12 | Katayama Orthopedic Rheumatology Clinic | Asahikawa | Hokkaido | Japan | 078-8243 |
| 13 | Sapporo city general hospital | Sapporo | Hokkaido | Japan | 060-8604 |
| 14 | Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
| 15 | Hokkaido Medical Center for Rheumatic Diseases | Sapporo | Hokkaido | Japan | 063-0811 |
| 16 | The Hospital of Hyogo College of Medicine | Nishinomiya | Hyogo | Japan | 663-8501 |
| 17 | Taga General Hospital | Hitachi-shi | Ibaraki | Japan | 316-0035 |
| 18 | Tsukuba University Hospital | Tsukuba | Ibaraki | Japan | 305-8576 |
| 19 | National Hospital Organization Sagamihara National Hospital | Sagamihara | Kanagawa | Japan | 252-0392 |
| 20 | Kumamoto Saishunso National Hospital | Koushi | Kumamoto | Japan | 861-1196 |
| 21 | National hospital Organization Mie Chuou Medical Center | Tsu | Mie | Japan | 514-1101 |
| 22 | Hikarigaoka Spellman Hospital | Sendai | Miyagi | Japan | 983-0833 |
| 23 | National Hospital Organization Nagasaki Medical Center | Ohmura | Nagasaki | Japan | 856-0835 |
| 24 | Sasebo Chuo Hospital | Sasebo | Nagasaki | Japan | 857-1195 |
| 25 | Higami hospital | Kashihara | Nara | Japan | 634-0007 |
| 26 | National Hospital Organization Osaka Minami Center | Kawachinagano | Osaka | Japan | 586-8521 |
| 27 | Ureshino Medical Center | Ureshino | Saga | Japan | 843-0393 |
| 28 | Saitama Medical Center | Kawagoe-shi | Saitama | Japan | 350-8550 |
| 29 | Kitasato University Kitasato Institute Medical Center Hospital | Kitamoto | Saitama | Japan | 364-8501 |
| 30 | Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | Japan | 430-8558 |
| 31 | Tokyo Women's Medical University Medical Center East | Arakawa-ku | Tokyo | Japan | 116-8567 |
| 32 | Juntendo University Hospital | Bunkyo-ku | Tokyo | Japan | 113-8431 |
| 33 | Tokyo Medical And Dental University Hospital, Faculty of Medicine | Bunkyo-ku | Tokyo | Japan | 113-8519 |
| 34 | The University of Tokyo Hospital | Bunkyo-ku | Tokyo | Japan | 113-8655 |
| 35 | Sasaki Foundation Kyoundo Hospital | Chiyoda-ku | Tokyo | Japan | 101-0062 |
| 36 | Juntendo Tokyo Koto Geriatric Medical Center | Koto-ku | Tokyo | Japan | 136-0075 |
| 37 | National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo | Japan | 152-8902 |
| 38 | National Hospital Organization MURAYAMA Medical Center | Musashimurayama-shi | Tokyo | Japan | 208-0011 |
| 39 | Fukuhara Hospital | Setagaya-ku | Tokyo | Japan | 155-0031 |
| 40 | Tokyo Women's Medical University, Institute of Rheumatology | Shinjyuku-ku | Tokyo | Japan | 162-0054 |
| 41 | National Hospital Organization Chiba-East Hospital | Chiba | Japan | 260-8712 | |
| 42 | Kondo clinic for rheumatism and orthopaedics | Fukuoka | Japan | 810-0001 | |
| 43 | National Hospital Organization Kyushu Medical Center | Fukuoka | Japan | 810-8563 | |
| 44 | Medical Co.LTA PS Clinic | Fukuoka | Japan | 812-0025 | |
| 45 | Fukusima Daiichi Hospital | Fukusima | Japan | 960-8251 | |
| 46 | Hiroshima Rheumatology Clinic | Hiroshima | Japan | 730-0017 | |
| 47 | Kumamoto Orthopaedic Hospital | Kumamoto | Japan | 862-0976 | |
| 48 | University Hospital, Kyoto Prefectural University of Medicine | Kyoto | Japan | 602-8566 | |
| 49 | Kyoto University Hospital | Kyoto | Japan | 606-8507 | |
| 50 | Sendai Taihaku Hospital | Miyagi | Japan | 982-0032 | |
| 51 | Nagasaki University Hospital of Medicine and Dentistry | Nagasaki | Japan | 852-8501 | |
| 52 | Niigata University Medical & Dental Hospital | Niigata | Japan | 951-8520 | |
| 53 | A Medical Corporation Oribe Rheumatism Internist Clinic | Oita | Japan | 870-0823 | |
| 54 | The Tazuke Kofukai Medical Research Institute Kitano Hospital | Osaka | Japan | 530-8480 | |
| 55 | Saitama city hospital | Saitama | Japan | 336-8522 | |
| 56 | Keio University Hospital | Shinjuku-ku, Tokyo | Japan | 160-8582 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00661661
Other Study ID Numbers:
- A3921041
First Posted:
Apr 18, 2008
Last Update Posted:
May 12, 2015
Last Verified:
Apr 1, 2015
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants received study drug (CP-690,550 or placebo) in the precedent study A3921039 (NCT00603512) for 12 weeks, A3921040 (NCT00687193) for 12 weeks, or A3921044 (NCT00847613) for 2 years. |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID |
|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. |
| Period Title: Overall Study | ||
| STARTED | 382 | 105 |
| COMPLETED | 242 | 66 |
| NOT COMPLETED | 140 | 39 |
Baseline Characteristics
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | Total of all reporting groups |
| Overall Participants | 381 | 105 | 486 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.5
(11.2)
|
49.3
(11.7)
|
52.6
(11.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
318
83.5%
|
86
81.9%
|
404
83.1%
|
| Male |
63
16.5%
|
19
18.1%
|
82
16.9%
|
Outcome Measures
| Title | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
|---|---|
| Description | ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
80.2
21%
|
68.6
65.3%
|
77.6
16%
|
| Week 4 (n=373, 105, 478) |
87.1
22.9%
|
70.5
67.1%
|
83.5
17.2%
|
| Week 8 (n=371, 105, 476) |
90.0
23.6%
|
72.4
69%
|
86.1
17.7%
|
| Week 12 (n=370, 105, 475) |
91.9
24.1%
|
77.1
73.4%
|
88.6
18.2%
|
| Week 24 (n=357, 104, 461) |
90.8
23.8%
|
85.6
81.5%
|
89.6
18.4%
|
| Week 36 (n=339, 102, 441) |
94.1
24.7%
|
87.3
83.1%
|
92.5
19%
|
| Week 48 (n=331, 102, 433) |
93.7
24.6%
|
88.2
84%
|
92.4
19%
|
| Week 60 (n=323, 102, 425) |
92.3
24.2%
|
90.2
85.9%
|
91.8
18.9%
|
| Week 72 (n=315, 99, 414) |
92.4
24.3%
|
86.9
82.8%
|
91.1
18.7%
|
| Week 84 (n=309, 92, 401) |
93.2
24.5%
|
87.0
82.9%
|
91.8
18.9%
|
| Week 96 (n=281, 87, 368) |
92.2
24.2%
|
92.0
87.6%
|
92.1
19%
|
| Week 108 (n=259, 84, 343) |
91.9
24.1%
|
86.9
82.8%
|
90.7
18.7%
|
| Week 120 (n=242, 80, 322) |
91.3
24%
|
88.8
84.6%
|
90.7
18.7%
|
| Week 132 (n=232, 79, 311) |
92.2
24.2%
|
84.8
80.8%
|
90.4
18.6%
|
| Week 144 (n=224, 76, 300) |
89.7
23.5%
|
86.8
82.7%
|
89.0
18.3%
|
| Week 156 (n=219, 73, 292) |
91.3
24%
|
84.9
80.9%
|
89.7
18.5%
|
| Week 168 (n=213, 70, 283) |
92.5
24.3%
|
82.9
79%
|
90.1
18.5%
|
| Week 180 (n=180, 57, 237) |
92.8
24.4%
|
86.0
81.9%
|
91.1
18.7%
|
| Week 192 (n=138, 42, 180) |
92.8
24.4%
|
85.7
81.6%
|
91.1
18.7%
|
| Week 204 (n=109, 30, 139) |
92.7
24.3%
|
90.0
85.7%
|
92.1
19%
|
| Week 216 (n=76, 13, 89) |
96.1
25.2%
|
84.6
80.6%
|
94.4
19.4%
|
| Week 228 (n=68, 5, 73) |
91.2
23.9%
|
80.0
76.2%
|
90.4
18.6%
|
| Week 240 (n=65, 5, 70) |
93.8
24.6%
|
80.0
76.2%
|
92.9
19.1%
|
| Week 252 (n=65, 5, 70) |
92.3
24.2%
|
80.0
76.2%
|
91.4
18.8%
|
| Week 264 (n=59, 5, 64) |
89.8
23.6%
|
80.0
76.2%
|
89.1
18.3%
|
| Week 276 (n=22, 1, 23) |
95.5
25.1%
|
100
95.2%
|
95.7
19.7%
|
| Week 288 (n=3, 0, 3) |
100
26.2%
|
0
0%
|
100
20.6%
|
| Title | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
|---|---|
| Description | ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
59.5
15.6%
|
36.2
34.5%
|
54.5
11.2%
|
| Week 4 (n=373, 105, 478) |
63.8
16.7%
|
35.2
33.5%
|
57.5
11.8%
|
| Week 8 (n=371, 105, 476) |
70.4
18.5%
|
47.6
45.3%
|
65.3
13.4%
|
| Week 12 (n=370, 105, 475) |
70.8
18.6%
|
46.7
44.5%
|
65.5
13.5%
|
| Week 24 (n=357, 104, 461) |
76.2
20%
|
62.5
59.5%
|
73.1
15%
|
| Week 36 (n=339, 102, 441) |
77.3
20.3%
|
56.9
54.2%
|
72.6
14.9%
|
| Week 48 (n=331, 102, 433) |
77.3
20.3%
|
59.8
57%
|
73.2
15.1%
|
| Week 60 (n=323, 102, 425) |
77.1
20.2%
|
66.7
63.5%
|
74.6
15.3%
|
| Week 72 (n=315, 99, 414) |
77.8
20.4%
|
74.7
71.1%
|
77.1
15.9%
|
| Week 84 (n=309, 92, 401) |
78.6
20.6%
|
64.1
61%
|
75.3
15.5%
|
| Week 96 (n=281, 87, 368) |
78.3
20.6%
|
60.9
58%
|
74.2
15.3%
|
| Week 108 (n=259, 84, 343) |
79.9
21%
|
72.6
69.1%
|
78.1
16.1%
|
| Week 120 (n=242, 80, 322) |
76.4
20.1%
|
68.8
65.5%
|
74.5
15.3%
|
| Week 132 (n=232, 79, 311) |
77.2
20.3%
|
72.2
68.8%
|
75.9
15.6%
|
| Week 144 (n=224, 76, 300) |
78.1
20.5%
|
69.7
66.4%
|
76.0
15.6%
|
| Week 156 (n=219, 73, 292) |
79.5
20.9%
|
65.8
62.7%
|
76.0
15.6%
|
| Week 168 (n=213, 70, 283) |
79.3
20.8%
|
67.1
63.9%
|
76.3
15.7%
|
| Week 180 (n=180, 57, 237) |
82.2
21.6%
|
71.9
68.5%
|
79.7
16.4%
|
| Week 192 (n=138, 42, 180) |
79.7
20.9%
|
61.9
59%
|
75.6
15.6%
|
| Week 204 (n=109, 30, 139) |
84.4
22.2%
|
80.0
76.2%
|
83.5
17.2%
|
| Week 216 (n=76, 13, 89) |
86.8
22.8%
|
53.8
51.2%
|
82.0
16.9%
|
| Week 228 (n=68, 5, 73) |
76.5
20.1%
|
80.0
76.2%
|
76.7
15.8%
|
| Week 240 (n=65, 5, 70) |
83.1
21.8%
|
40.0
38.1%
|
80.0
16.5%
|
| Week 252 (n=65, 5, 70) |
86.2
22.6%
|
40.0
38.1%
|
82.9
17.1%
|
| Week 264 (n=59, 5, 64) |
84.7
22.2%
|
40.0
38.1%
|
81.3
16.7%
|
| Week 276 (n=22, 1, 23) |
81.8
21.5%
|
100
95.2%
|
82.6
17%
|
| Week 288 (n=3, 0, 3) |
100
26.2%
|
0
0%
|
100
20.6%
|
| Title | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
|---|---|
| Description | ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
37.0
9.7%
|
19.0
18.1%
|
33.1
6.8%
|
| Week 4 (n=373, 105, 478) |
44.8
11.8%
|
20.2
19.2%
|
39.3
8.1%
|
| Week 8 (n=371, 105, 476) |
47.7
12.5%
|
21.0
20%
|
41.8
8.6%
|
| Week 12 (n=370, 105, 475) |
50.0
13.1%
|
16.2
15.4%
|
42.5
8.7%
|
| Week 24 (n=357, 104, 461) |
54.1
14.2%
|
27.9
26.6%
|
48.2
9.9%
|
| Week 36 (n=339, 102, 441) |
56.6
14.9%
|
24.5
23.3%
|
49.2
10.1%
|
| Week 48 (n=331, 102, 433) |
59.8
15.7%
|
34.3
32.7%
|
53.8
11.1%
|
| Week 60 (n=323, 102, 425) |
59.1
15.5%
|
37.3
35.5%
|
53.9
11.1%
|
| Week 72 (n=315, 99, 414) |
61.9
16.2%
|
38.4
36.6%
|
56.3
11.6%
|
| Week 84 (n=309, 92, 401) |
60.2
15.8%
|
35.9
34.2%
|
54.6
11.2%
|
| Week 96 (n=281, 87, 368) |
59.4
15.6%
|
42.5
40.5%
|
55.4
11.4%
|
| Week 108 (n=259, 84, 343) |
60.6
15.9%
|
42.9
40.9%
|
56.3
11.6%
|
| Week 120 (n=242, 80, 322) |
62.0
16.3%
|
37.5
35.7%
|
55.9
11.5%
|
| Week 132 (n=232, 79, 311) |
60.8
16%
|
40.5
38.6%
|
55.6
11.4%
|
| Week 144 (n=224, 76, 300) |
61.2
16.1%
|
35.5
33.8%
|
54.7
11.3%
|
| Week 156 (n=219, 73, 292) |
61.6
16.2%
|
41.1
39.1%
|
56.5
11.6%
|
| Week 168 (n=213, 70, 283) |
62.9
16.5%
|
41.4
39.4%
|
57.6
11.9%
|
| Week 180 (n=180, 57, 237) |
63.9
16.8%
|
47.4
45.1%
|
59.9
12.3%
|
| Week 192 (n=138, 42, 180) |
63.8
16.7%
|
42.9
40.9%
|
58.9
12.1%
|
| Week 204 (n=109, 30, 139) |
62.4
16.4%
|
56.7
54%
|
61.2
12.6%
|
| Week 216 (n=76, 13, 89) |
69.7
18.3%
|
30.8
29.3%
|
64.0
13.2%
|
| Week 228 (n=68, 5, 73) |
63.2
16.6%
|
20.0
19%
|
60.3
12.4%
|
| Week 240 (n=65, 5, 70) |
69.2
18.2%
|
20.0
19%
|
65.7
13.5%
|
| Week 252 (n=65, 5, 70) |
73.8
19.4%
|
20.0
19%
|
70.0
14.4%
|
| Week 264 (n=59, 5, 64) |
71.2
18.7%
|
20.0
19%
|
67.2
13.8%
|
| Week 276 (n=22, 1, 23) |
68.2
17.9%
|
0
0%
|
65.2
13.4%
|
| Week 288 (n=3, 0, 3) |
66.7
17.5%
|
0
0%
|
66.7
13.7%
|
| Title | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
|---|---|
| Description | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
-0.55
(0.03)
|
-0.44
(0.05)
|
-0.53
(0.03)
|
| Week 4 (n=372, 105, 477) |
-0.61
(0.03)
|
-0.45
(0.05)
|
-0.57
(0.03)
|
| Week 8 (n=371, 105, 476) |
-0.66
(0.03)
|
-0.49
(0.05)
|
-0.62
(0.03)
|
| Week 12 (n=370, 105, 475) |
-0.66
(0.03)
|
-0.51
(0.05)
|
-0.63
(0.03)
|
| Week 24 (n=357, 104, 461) |
-0.69
(0.03)
|
-0.55
(0.05)
|
-0.65
(0.03)
|
| Week 36 (n=339, 102, 441) |
-0.70
(0.03)
|
-0.54
(0.05)
|
-0.66
(0.03)
|
| Week 48 (n=331, 102, 433) |
-0.70
(0.03)
|
-0.62
(0.05)
|
-0.68
(0.03)
|
| Week 60 (n=323, 102, 425) |
-0.71
(0.03)
|
-0.57
(0.05)
|
-0.67
(0.03)
|
| Week 72 (n=315, 99, 414) |
-0.72
(0.03)
|
-0.60
(0.05)
|
-0.69
(0.03)
|
| Week 84 (n=309, 92, 401) |
-0.72
(0.04)
|
-0.61
(0.05)
|
-0.69
(0.03)
|
| Week 96 (n=281, 87, 368) |
-0.72
(0.04)
|
-0.61
(0.06)
|
-0.69
(0.03)
|
| Week 108 (n=259, 84, 343) |
-0.70
(0.04)
|
-0.64
(0.06)
|
-0.69
(0.03)
|
| Week 120 (n=242, 80, 322) |
-0.70
(0.04)
|
-0.63
(0.06)
|
-0.68
(0.03)
|
| Week 132 (n=232, 79, 311) |
-0.70
(0.04)
|
-0.64
(0.06)
|
-0.68
(0.03)
|
| Week 144 (n=224, 76, 300) |
-0.67
(0.04)
|
-0.59
(0.07)
|
-0.65
(0.04)
|
| Week 156 (n=219, 72, 291) |
-0.68
(0.04)
|
-0.62
(0.06)
|
-0.66
(0.03)
|
| Week 168 (n=213, 70, 283) |
-0.68
(0.04)
|
-0.57
(0.07)
|
-0.65
(0.04)
|
| Week 180 (n=180, 57, 237) |
-0.70
(0.05)
|
-0.63
(0.08)
|
-0.68
(0.04)
|
| Week 192 (n=138, 42, 180) |
-0.69
(0.05)
|
-0.61
(0.09)
|
-0.67
(0.05)
|
| Week 204 (n=109, 30, 139) |
-0.67
(0.06)
|
-0.67
(0.09)
|
-0.67
(0.05)
|
| Week 216 (n=76, 13, 89) |
-0.62
(0.06)
|
-0.42
(0.09)
|
-0.59
(0.05)
|
| Week 228 (n=68, 5, 73) |
-0.62
(0.06)
|
-0.25
(0.10)
|
-0.59
(0.06)
|
| Week 240 (n=65, 5, 70) |
-0.66
(0.06)
|
-0.33
(0.14)
|
-0.64
(0.06)
|
| Week 252 (n=65, 5, 70) |
-0.68
(0.07)
|
-0.25
(0.12)
|
-0.65
(0.06)
|
| Week 264 (n=59, 5, 64) |
-0.65
(0.07)
|
-0.23
(0.07)
|
-0.62
(0.07)
|
| Week 276 (n=22, 1, 23) |
-0.83
(0.11)
|
-0.63
(NA)
|
-0.82
(0.11)
|
| Week 288 (n=3, 0, 3) |
-0.96
(0.37)
|
NA
(NA)
|
-0.96
(0.37)
|
| Title | Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) |
|---|---|
| Description | DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
-2.60
(0.07)
|
-1.94
(0.13)
|
-2.45
(0.06)
|
| Week 4 (n=372, 105, 477) |
-2.77
(0.07)
|
-1.95
(0.13)
|
-2.59
(0.06)
|
| Week 8 (n=371, 104, 475) |
-2.95
(0.06)
|
-2.14
(0.12)
|
-2.77
(0.06)
|
| Week 12 (n=370, 105, 475) |
-3.01
(0.06)
|
-2.08
(0.12)
|
-2.81
(0.06)
|
| Week 24 (n=357, 104, 461) |
-3.12
(0.06)
|
-2.42
(0.12)
|
-2.96
(0.06)
|
| Week 36 (n=339, 102, 441) |
-3.18
(0.07)
|
-2.54
(0.13)
|
-3.03
(0.06)
|
| Week 48 (n=331, 102, 433) |
-3.20
(0.07)
|
-2.72
(0.13)
|
-3.08
(0.06)
|
| Week 60 (n=323, 101, 424) |
-3.25
(0.07)
|
-2.80
(0.12)
|
-3.15
(0.06)
|
| Week 72 (n=315, 99, 414) |
-3.20
(0.07)
|
-2.83
(0.12)
|
-3.11
(0.06)
|
| Week 84 (n=309, 92, 401) |
-3.26
(0.07)
|
-2.86
(0.14)
|
-3.17
(0.06)
|
| Week 96 (n=281, 87, 368) |
-3.21
(0.07)
|
-2.87
(0.14)
|
-3.13
(0.07)
|
| Week 108 (n=259, 83, 342) |
-3.22
(0.08)
|
-2.83
(0.15)
|
-3.12
(0.07)
|
| Week 120 (n=242, 79, 321) |
-3.24
(0.08)
|
-2.78
(0.14)
|
-3.12
(0.07)
|
| Week 132 (n=232, 79, 311) |
-3.14
(0.08)
|
-2.84
(0.15)
|
-3.07
(0.07)
|
| Week 144 (n=224, 76, 300) |
-3.17
(0.09)
|
-2.84
(0.16)
|
-3.09
(0.08)
|
| Week 156 (n=218, 72, 290) |
-3.08
(0.09)
|
-2.84
(0.16)
|
-3.02
(0.08)
|
| Week 168 (n=213, 70, 283) |
-3.16
(0.09)
|
-2.87
(0.17)
|
-3.09
(0.08)
|
| Week 180 (n=178, 56, 234) |
-3.21
(0.10)
|
-3.06
(0.19)
|
-3.18
(0.09)
|
| Week 192 (n=138, 42, 180) |
-3.17
(0.11)
|
-3.07
(0.19)
|
-3.15
(0.09)
|
| Week 204 (n=109, 30, 139) |
-3.24
(0.12)
|
-3.35
(0.25)
|
-3.26
(0.11)
|
| Week 216 (n=76, 13, 89) |
-3.20
(0.13)
|
-2.44
(0.44)
|
-3.09
(0.13)
|
| Week 228 (n=68, 5, 73) |
-3.08
(0.17)
|
-2.25
(0.58)
|
-3.02
(0.16)
|
| Week 240 (n=65, 5, 70) |
-3.22
(0.15)
|
-2.61
(0.70)
|
-3.17
(0.14)
|
| Week 252 (n=65, 5, 70) |
-3.33
(0.15)
|
-1.81
(0.51)
|
-3.23
(0.15)
|
| Week 264 (n=59, 5, 64) |
-3.32
(0.15)
|
-2.09
(0.45)
|
-3.23
(0.14)
|
| Week 276 (n=21, 1, 22) |
-3.34
(0.25)
|
-2.15
(NA)
|
-3.29
(0.24)
|
| Week 288 (n=3, 0, 3) |
-2.95
(0.51)
|
NA
(NA)
|
-2.95
(0.51)
|
| Title | Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
|---|---|
| Description | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
-2.44
(0.06)
|
-1.90
(0.12)
|
-2.32
(0.06)
|
| Week 4 (n=372, 105, 477) |
-2.55
(0.06)
|
-1.90
(0.12)
|
-2.41
(0.06)
|
| Week 8 (n=371, 105, 476) |
-2.68
(0.06)
|
-2.06
(0.11)
|
-2.55
(0.05)
|
| Week 12 (n=370, 105, 475) |
-2.75
(0.06)
|
-1.97
(0.11)
|
-2.57
(0.05)
|
| Week 24 (n=357, 104, 461) |
-2.85
(0.06)
|
-2.29
(0.11)
|
-2.72
(0.05)
|
| Week 36 (n=337, 102, 439) |
-2.92
(0.06)
|
-2.45
(0.11)
|
-2.81
(0.05)
|
| Week 48 (n=331, 102, 433) |
-2.92
(0.06)
|
-2.58
(0.12)
|
-2.84
(0.05)
|
| Week 60 (n=322, 102, 424) |
-2.92
(0.06)
|
-2.60
(0.11)
|
-2.85
(0.05)
|
| Week 72 (n=315, 99, 414) |
-2.93
(0.06)
|
-2.61
(0.11)
|
-2.86
(0.05)
|
| Week 84 (n=309, 92, 401) |
-2.98
(0.06)
|
-2.70
(0.12)
|
-2.92
(0.06)
|
| Week 96 (n=281, 87, 368) |
-2.95
(0.07)
|
-2.69
(0.13)
|
-2.88
(0.06)
|
| Week 108 (n=259, 83, 342) |
-2.93
(0.07)
|
-2.64
(0.13)
|
-2.86
(0.06)
|
| Week 120 (n=242, 80, 322) |
-2.97
(0.07)
|
-2.60
(0.13)
|
-2.88
(0.06)
|
| Week 132 (n=231, 79, 310) |
-2.89
(0.07)
|
-2.66
(0.13)
|
-2.83
(0.06)
|
| Week 144 (n=224, 76, 300) |
-2.90
(0.08)
|
-2.68
(0.14)
|
-2.85
(0.07)
|
| Week 156 (n=219, 72, 291) |
-2.84
(0.08)
|
-2.70
(0.14)
|
-2.81
(0.07)
|
| Week 168 (n=213, 70, 283) |
-2.90
(0.08)
|
-2.68
(0.15)
|
-2.84
(0.07)
|
| Week 180 (n=180, 57, 237) |
-2.92
(0.09)
|
-2.80
(0.17)
|
-2.89
(0.08)
|
| Week 192 (n=138, 42, 180) |
-2.93
(0.09)
|
-2.84
(0.16)
|
-2.91
(0.08)
|
| Week 204 (n=109, 30, 139) |
-2.95
(0.11)
|
-3.05
(0.22)
|
-2.97
(0.10)
|
| Week 216 (n=76, 13, 89) |
-2.94
(0.12)
|
-2.46
(0.34)
|
-2.87
(0.12)
|
| Week 228 (n=68, 5, 73) |
-2.84
(0.17)
|
-2.38
(0.44)
|
-2.81
(0.16)
|
| Week 240 (n=65, 5, 70) |
-2.97
(0.13)
|
-2.36
(0.57)
|
-2.92
(0.13)
|
| Week 252 (n=65, 5, 70) |
-3.09
(0.14)
|
-1.89
(0.42)
|
-3.00
(0.14)
|
| Week 264 (n=58, 5, 63) |
-3.13
(0.15)
|
-1.86
(0.30)
|
-3.03
(0.14)
|
| Week 276 (n=22, 1, 23) |
-3.24
(0.24)
|
-1.50
(NA)
|
-3.16
(0.24)
|
| Week 288 (n=3, 0, 3) |
-2.67
(0.27)
|
NA
(NA)
|
-2.67
(0.27)
|
| Title | Change From Baseline in Patient Global Assessment of Arthritis |
|---|---|
| Description | Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
-34.52
(1.38)
|
-25.38
(2.43)
|
-32.54
(1.21)
|
| Week 4 (n=372, 105, 477) |
-37.81
(1.36)
|
-25.34
(2.61)
|
-35.06
(1.23)
|
| Week 8 (n=371, 105, 476) |
-39.61
(1.35)
|
-28.86
(2.31)
|
-37.24
(1.19)
|
| Week 12 (n=370, 105, 475) |
-39.31
(1.38)
|
-27.33
(2.23)
|
-36.67
(1.20)
|
| Week 24 (n=357, 104, 461) |
-40.67
(1.39)
|
-30.75
(2.53)
|
-38.43
(1.24)
|
| Week 36 (n=339, 102, 441) |
-41.70
(1.42)
|
-29.95
(2.63)
|
-38.98
(1.27)
|
| Week 48 (n=331, 102, 433) |
-41.03
(1.46)
|
-32.48
(2.56)
|
-39.02
(1.28)
|
| Week 60 (n=323, 102, 425) |
-41.79
(1.44)
|
-34.33
(2.42)
|
-40.00
(1.25)
|
| Week 72 (n=315, 99, 414) |
-41.30
(1.53)
|
-35.38
(2.31)
|
-39.88
(1.29)
|
| Week 84 (n=309, 92, 401) |
-42.29
(1.53)
|
-35.12
(2.63)
|
-40.65
(1.33)
|
| Week 96 (n=281, 87, 368) |
-41.90
(1.62)
|
-34.98
(2.88)
|
-40.27
(1.42)
|
| Week 108 (n=259, 84, 343) |
-42.47
(1.67)
|
-34.95
(2.98)
|
-40.63
(1.46)
|
| Week 120 (n=242, 80, 322) |
-42.97
(1.71)
|
-35.00
(3.05)
|
-40.99
(1.50)
|
| Week 132 (n=232, 79, 311) |
-42.87
(1.73)
|
-35.05
(3.13)
|
-40.88
(1.52)
|
| Week 144 (n=224, 76, 300) |
-42.48
(1.77)
|
-33.78
(3.22)
|
-40.27
(1.57)
|
| Week 156 (n=219, 72, 291) |
-42.72
(1.71)
|
-32.64
(3.13)
|
-40.22
(1.52)
|
| Week 168 (n=213, 70, 283) |
-43.00
(1.72)
|
-33.61
(3.22)
|
-40.67
(1.53)
|
| Week 180 (n=180, 57, 237) |
-43.22
(1.91)
|
-36.14
(3.72)
|
-41.52
(1.71)
|
| Week 192 (n=138, 42, 180) |
-42.05
(2.10)
|
-34.40
(3.95)
|
-40.27
(1.86)
|
| Week 204 (n=109, 30, 139) |
-42.44
(2.36)
|
-35.73
(5.31)
|
-40.99
(2.18)
|
| Week 216 (n=76, 13, 89) |
-42.04
(2.87)
|
-23.92
(9.22)
|
-39.39
(2.86)
|
| Week 228 (n=68, 5, 73) |
-37.09
(2.96)
|
-17.60
(10.66)
|
-35.75
(2.89)
|
| Week 240 (n=65, 5, 70) |
-38.91
(2.98)
|
-18.20
(8.36)
|
-37.43
(2.89)
|
| Week 252 (n=65, 5, 70) |
-40.37
(2.92)
|
-7.60
(9.17)
|
-38.03
(2.95)
|
| Week 264 (n=59, 5, 64) |
-37.32
(3.69)
|
-16.20
(9.01)
|
-35.67
(3.54)
|
| Week 276 (n=21, 1, 22) |
-35.62
(6.09)
|
-10.00
(NA)
|
-34.45
(5.92)
|
| Week 288 (n=3, 0, 3) |
-41.67
(7.31)
|
NA
(NA)
|
-41.67
(7.31)
|
| Title | Change From Baseline in Physician Global Assessment of Arthritis |
|---|---|
| Description | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
-42.80
(1.13)
|
-33.49
(2.01)
|
-40.78
(1.00)
|
| Week 4 (n=372, 105, 477) |
-46.06
(1.08)
|
-34.91
(2.20)
|
-43.60
(0.99)
|
| Week 8 (n=371, 105, 476) |
-47.34
(1.06)
|
-37.15
(2.00)
|
-45.09
(0.95)
|
| Week 12 (n=370, 105, 475) |
-47.78
(1.09)
|
-36.56
(2.33)
|
-45.30
(1.00)
|
| Week 24 (n=357, 104, 461) |
-48.29
(1.07)
|
-41.26
(2.01)
|
-46.70
(0.95)
|
| Week 36 (n=339, 102, 441) |
-49.28
(1.09)
|
-41.92
(2.01)
|
-47.58
(0.97)
|
| Week 48 (n=331, 102, 433) |
-49.96
(1.13)
|
-45.28
(2.08)
|
-48.86
(1.00)
|
| Week 60 (n=323, 102, 425) |
-49.89
(1.14)
|
-47.01
(2.05)
|
-49.20
(1.00)
|
| Week 72 (n=315, 99, 414) |
-50.03
(1.14)
|
-45.70
(1.95)
|
-48.99
(0.99)
|
| Week 84 (n=309, 92, 401) |
-50.61
(1.16)
|
-46.89
(2.17)
|
-49.75
(1.02)
|
| Week 96 (n=281, 87, 368) |
-49.99
(1.28)
|
-48.16
(2.23)
|
-49.55
(1.11)
|
| Week 108 (n=259, 83, 342) |
-49.62
(1.33)
|
-47.99
(2.56)
|
-49.22
(1.18)
|
| Week 120 (n=242, 80, 322) |
-49.42
(1.47)
|
-47.76
(2.39)
|
-49.01
(1.26)
|
| Week 132 (n=231, 78, 309) |
-49.99
(1.41)
|
-50.19
(2.33)
|
-50.04
(1.20)
|
| Week 144 (n=224, 76, 300) |
-50.80
(1.46)
|
-49.55
(2.44)
|
-50.49
(1.25)
|
| Week 156 (n=219, 72, 291) |
-50.68
(1.39)
|
-49.78
(2.58)
|
-50.46
(1.23)
|
| Week 168 (n=213, 70, 283) |
-51.52
(1.45)
|
-46.33
(2.60)
|
-50.23
(1.27)
|
| Week 180 (n=180, 57, 237) |
-52.20
(1.51)
|
-50.33
(2.84)
|
-51.75
(1.33)
|
| Week 192 (n=138, 42, 180) |
-51.41
(1.72)
|
-50.43
(2.98)
|
-51.18
(1.49)
|
| Week 204 (n=109, 30, 139) |
-51.10
(1.73)
|
-50.97
(4.12)
|
-51.07
(1.61)
|
| Week 216 (n=76, 13, 89) |
-50.91
(2.01)
|
-42.77
(6.37)
|
-49.72
(1.96)
|
| Week 228 (n=67, 5, 72) |
-49.57
(2.37)
|
-33.60
(8.88)
|
-48.46
(2.33)
|
| Week 240 (n=65, 5, 70) |
-49.94
(2.25)
|
-34.40
(10.30)
|
-48.83
(2.25)
|
| Week 252 (n=65, 5, 70) |
-51.78
(2.17)
|
-31.60
(7.92)
|
-50.34
(2.17)
|
| Week 264 (n=58, 5, 63) |
-52.62
(2.36)
|
-33.80
(9.49)
|
-51.13
(2.36)
|
| Week 276 (n=21, 1, 22) |
-53.05
(3.92)
|
-7.00
(NA)
|
-50.95
(4.29)
|
| Week 288 (n=3, 0, 3) |
-37.67
(1.33)
|
NA
(NA)
|
-37.67
(1.33)
|
| Title | Change From Baseline in Patient Assessment of Arthritis Pain |
|---|---|
| Description | Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n= 378, 105, 483) |
-34.23
(1.40)
|
-27.98
(2.39)
|
-32.87
(1.22)
|
| Week 4 (n=372, 105, 477) |
-37.32
(1.38)
|
-27.70
(2.61)
|
-35.20
(1.23)
|
| Week 8 (n=371, 105, 476) |
-39.54
(1.34)
|
-30.69
(2.32)
|
-37.59
(1.17)
|
| Week 12 (n=370, 105, 475) |
-39.34
(1.36)
|
-29.03
(2.25)
|
-37.06
(1.18)
|
| Week 24 (n=357, 104, 461) |
-40.70
(1.42)
|
-33.60
(2.50)
|
-39.10
(1.24)
|
| Week 36 (n=339, 102, 441) |
-41.70
(1.45)
|
-32.71
(2.56)
|
-39.62
(1.27)
|
| Week 48 (n=331, 102, 433) |
-41.98
(1.41)
|
-34.39
(2.52)
|
-40.19
(1.24)
|
| Week 60 (n=323, 102, 425) |
-42.37
(1.44)
|
-36.65
(2.36)
|
-41.00
(1.24)
|
| Week 72 (n=315, 99, 414) |
-41.84
(1.51)
|
-37.41
(2.28)
|
-40.79
(1.28)
|
| Week 84 (n=309, 92, 401) |
-42.49
(1.53)
|
-37.65
(2.55)
|
-41.38
(1.32)
|
| Week 96 (n=281, 87, 368) |
-42.21
(1.63)
|
-38.21
(2.87)
|
-41.27
(1.42)
|
| Week 108 (n=259, 84, 343) |
-42.61
(1.68)
|
-37.99
(2.87)
|
-41.48
(1.45)
|
| Week 120 (n=242, 80, 322) |
-42.44
(1.74)
|
-37.45
(2.92)
|
-41.20
(1.50)
|
| Week 132 (n=232, 79, 311) |
-42.52
(1.78)
|
-37.86
(3.04)
|
-41.33
(1.54)
|
| Week 144 (n=224, 76, 300) |
-42.05
(1.81)
|
-37.07
(3.09)
|
-40.79
(1.56)
|
| Week 156 (n=219, 72, 291) |
-43.77
(1.75)
|
-36.39
(2.89)
|
-41.94
(1.51)
|
| Week 168 (n=213, 70, 283) |
-43.87
(1.73)
|
-37.96
(3.24)
|
-42.41
(1.54)
|
| Week 180 (n=180, 57, 237) |
-43.85
(1.92)
|
-40.21
(3.51)
|
-42.97
(1.68)
|
| Week 192 (n=138, 42, 180) |
-42.64
(2.22)
|
-36.67
(3.93)
|
-41.24
(1.94)
|
| Week 204 (n=109, 30, 139) |
-41.11
(2.59)
|
-38.70
(5.25)
|
-40.59
(2.32)
|
| Week 216 (n=76, 13, 89) |
-41.61
(2.90)
|
-30.38
(9.30)
|
-39.97
(2.84)
|
| Week 228 (n=68, 5, 73) |
-37.19
(2.96)
|
-28.40
(12.48)
|
-36.59
(2.87)
|
| Week 240 (n=65, 5, 70) |
-36.72
(3.08)
|
-21.20
(7.85)
|
-35.61
(2.94)
|
| Week 252 (n=65, 5, 70) |
-38.54
(3.19)
|
-21.20
(10.56)
|
-37.30
(3.08)
|
| Week 264 (n=59, 5, 64) |
-36.80
(3.72)
|
-16.60
(11.91)
|
-35.22
(3.60)
|
| Week 276 (n=21, 1, 22) |
-40.19
(5.00)
|
-44.00
(NA)
|
-40.36
(4.77)
|
| Week 288 (n=3, 0, 3) |
-34.67
(9.82)
|
NA
(NA)
|
-34.67
(9.82)
|
| Title | Change From Baseline in Tender/Painful Joint Counts |
|---|---|
| Description | This was carried out on 68 joints. Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n=378, 105, 483) |
-11.88
(0.48)
|
-10.17
(0.95)
|
-11.51
(0.43)
|
| Week 4 (n=373, 105, 478) |
-12.13
(0.51)
|
-10.46
(0.90)
|
-11.77
(0.45)
|
| Week 8 (n=371, 105, 476) |
-13.06
(0.47)
|
-10.75
(0.96)
|
-12.55
(0.43)
|
| Week 12 (n=370, 105, 475) |
-13.41
(0.47)
|
-10.74
(0.97)
|
-12.82
(0.43)
|
| Week 24 (n=357, 104, 461) |
-14.02
(0.50)
|
-12.62
(0.89)
|
-13.70
(0.44)
|
| Week 36 (n=339, 102, 441) |
-14.32
(0.53)
|
-13.05
(0.94)
|
-14.03
(0.46)
|
| Week 48 (n=331, 102, 433) |
-14.23
(0.53)
|
-13.43
(0.99)
|
-14.04
(0.47)
|
| Week 60 (n=323, 102, 425) |
-14.23
(0.55)
|
-13.67
(0.94)
|
-14.09
(0.48)
|
| Week 72 (n=315, 99, 414) |
-14.45
(0.56)
|
-14.00
(0.96)
|
-14.34
(0.48)
|
| Week 84 (n=309, 92, 401) |
-14.39
(0.56)
|
-14.04
(1.11)
|
-14.31
(0.50)
|
| Week 96 (n=281, 87, 368) |
-14.44
(0.60)
|
-13.92
(1.03)
|
-14.32
(0.52)
|
| Week 108 (n=259, 83, 342) |
-14.46
(0.61)
|
-13.66
(1.14)
|
-14.26
(0.54)
|
| Week 120 (n=242, 80, 322) |
-14.67
(0.65)
|
-13.69
(1.07)
|
-14.42
(0.55)
|
| Week 132 (n=232, 79, 311) |
-14.01
(0.73)
|
-13.30
(1.33)
|
-13.83
(0.64)
|
| Week 144 (n=224, 76, 300) |
-14.45
(0.68)
|
-13.83
(1.18)
|
-14.29
(0.59)
|
| Week 156 (n=219, 72, 291) |
-14.24
(0.70)
|
-14.15
(1.20)
|
-14.22
(0.61)
|
| Week 168 (n=213, 70, 283) |
-14.41
(0.73)
|
-14.06
(1.25)
|
-14.33
(0.63)
|
| Week 180 (n=180, 57, 237) |
-14.78
(0.79)
|
-15.18
(1.46)
|
-14.87
(0.70)
|
| Week 192 (n=138, 42, 180) |
-15.01
(0.87)
|
-14.57
(1.42)
|
-14.91
(0.74)
|
| Week 204 (n=109, 30, 139) |
-14.79
(0.94)
|
-15.67
(1.93)
|
-14.98
(0.84)
|
| Week 216 (n=76, 13, 89) |
-14.42
(1.04)
|
-11.38
(2.64)
|
-13.98
(0.97)
|
| Week 228 (n=68, 5, 73) |
-13.78
(1.56)
|
-11.60
(5.46)
|
-13.63
(1.49)
|
| Week 240 (n=65, 5, 70) |
-15.11
(1.15)
|
-10.80
(4.92)
|
-14.80
(1.12)
|
| Week 252 (n=65, 5, 70) |
-15.34
(1.17)
|
-9.60
(4.55)
|
-14.93
(1.14)
|
| Week 264 (n=59, 5, 64) |
-15.54
(1.27)
|
-9.80
(3.95)
|
-15.09
(1.22)
|
| Week 276 (n=22, 1, 23) |
-17.55
(2.55)
|
-4.00
(NA)
|
-16.96
(2.51)
|
| Week 288 (n=3, 0, 3) |
-8.67
(1.20)
|
NA
(NA)
|
-8.67
(1.20)
|
| Title | Change From Baseline in Swollen Joint Counts |
|---|---|
| Description | Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 2 (n=378, 105, 483) |
-9.67
(0.38)
|
-8.69
(0.74)
|
-9.46
(0.34)
|
| Week 4 (n=373, 105, 478) |
-10.12
(0.42)
|
-8.54
(0.75)
|
-9.78
(0.37)
|
| Week 8 (n=371, 105, 476) |
-10.90
(0.39)
|
-9.31
(0.73)
|
-10.55
(0.35)
|
| Week 12 (n=370, 105, 475) |
-11.18
(0.40)
|
-9.21
(0.67)
|
-10.74
(0.35)
|
| Week 24 (n=357, 104, 461) |
-11.33
(0.40)
|
-10.46
(0.72)
|
-11.13
(0.35)
|
| Week 36 (n=339, 102, 441) |
-11.62
(0.43)
|
-10.75
(0.73)
|
-11.41
(0.37)
|
| Week 48 (n=331, 102, 433) |
-11.76
(0.44)
|
-11.11
(0.74)
|
-11.61
(0.38)
|
| Week 60 (n=323, 102, 425) |
-11.83
(0.44)
|
-10.97
(0.76)
|
-11.62
(0.38)
|
| Week 72 (n=315, 99, 414) |
-12.00
(0.46)
|
-11.38
(0.80)
|
-11.85
(0.40)
|
| Week 84 (n=309, 92, 401) |
-12.08
(0.47)
|
-11.72
(0.88)
|
-12.00
(0.41)
|
| Week 96 (n=281, 87, 368) |
-11.97
(0.50)
|
-11.54
(0.84)
|
-11.87
(0.43)
|
| Week 108 (n=259, 83, 342) |
-11.94
(0.52)
|
-11.60
(0.91)
|
-11.86
(0.45)
|
| Week 120 (n=242, 80, 322) |
-12.09
(0.56)
|
-11.24
(0.87)
|
-11.88
(0.47)
|
| Week 132 (n=232, 79, 311) |
-11.69
(0.64)
|
-11.15
(1.16)
|
-11.55
(0.56)
|
| Week 144 (n=224, 76, 300) |
-11.90
(0.61)
|
-11.74
(0.94)
|
-11.86
(0.51)
|
| Week 156 (n=219, 72, 291) |
-12.07
(0.61)
|
-11.86
(1.04)
|
-12.02
(0.52)
|
| Week 168 (n=213, 70, 283) |
-12.17
(0.62)
|
-11.67
(1.05)
|
-12.05
(0.54)
|
| Week 180 (n=180, 57, 237) |
-12.43
(0.70)
|
-12.26
(1.24)
|
-12.39
(0.61)
|
| Week 192 (n=138, 42, 180) |
-12.36
(0.79)
|
-12.48
(1.47)
|
-12.38
(0.69)
|
| Week 204 (n=109, 30, 139) |
-12.35
(0.82)
|
12.50
(1.89)
|
12.38
(0.76)
|
| Week 216 (n=76, 13, 89) |
-12.34
(0.99)
|
-9.00
(2.35)
|
-11.85
(0.91)
|
| Week 228 (n=68, 5, 73) |
-11.74
(1.47)
|
-11.00
(5.09)
|
-11.68
(1.41)
|
| Week 240 (n=65, 5, 70) |
-13.09
(1.12)
|
-11.40
(5.48)
|
-12.97
(1.10)
|
| Week 252 (n=65, 5, 70) |
-13.20
(1.15)
|
-10.60
(4.70)
|
-13.01
(1.11)
|
| Week 264 (n=59, 5, 64) |
-13.58
(1.24)
|
-10.00
(4.11)
|
-13.30
(1.19)
|
| Week 276 (n=22, 1, 23) |
-15.32
(2.53)
|
-6.00
(NA)
|
-14.91
(2.46)
|
| Week 288 (n=3, 0, 3) |
-8.33
(0.88)
|
NA
(NA)
|
-8.33
(0.88)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
7.87
(0.45)
|
5.94
(0.76)
|
7.45
(0.39)
|
| Week 24 (n=357, 104, 461) |
8.67
(0.46)
|
6.12
(1.01)
|
8.10
(0.42)
|
| Week 48 (n=331, 102, 433) |
9.06
(0.48)
|
6.84
(1.05)
|
8.54
(0.45)
|
| Week 72 (n=315, 99, 414) |
9.10
(0.51)
|
7.61
(0.93)
|
8.74
(0.45)
|
| Week 96 (n=281, 87, 368) |
9.11
(0.55)
|
8.26
(0.88)
|
8.91
(0.47)
|
| Week 120 (n=242, 80, 322) |
9.12
(0.57)
|
8.34
(1.09)
|
8.92
(0.51)
|
| Week 144 (n=224, 76, 300) |
8.85
(0.66)
|
7.57
(1.18)
|
8.53
(0.57)
|
| Week 168 (n=213, 70, 283) |
9.01
(0.68)
|
7.16
(1.36)
|
8.55
(0.61)
|
| Week 192 (n=138, 42, 180) |
9.43
(0.78)
|
8.09
(1.25)
|
9.12
(0.66)
|
| Week 216 (n=76, 13, 89) |
8.78
(0.98)
|
5.04
(2.27)
|
8.23
(0.91)
|
| Week 240 (n=65, 5, 70) |
8.91
(1.00)
|
3.27
(1.90)
|
8.51
(0.95)
|
| Week 264 (n=59, 5, 64) |
8.85
(1.08)
|
1.64
(1.98)
|
8.28
(1.03)
|
| Week 288 (n=3, 0, 3) |
10.23
(1.18)
|
NA
(NA)
|
10.23
(1.18)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
7.31
(0.57)
|
5.48
(1.00)
|
6.90
(0.50)
|
| Week 24 (n=357, 104, 461) |
8.21
(0.59)
|
6.29
(1.06)
|
7.77
(0.51)
|
| Week 48 (n=331, 102, 433) |
8.38
(0.64)
|
7.77
(0.92)
|
8.23
(0.53)
|
| Week 72 (n=315, 99, 414) |
7.23
(0.67)
|
7.47
(1.08)
|
7.29
(0.57)
|
| Week 96 (n=281, 87, 368) |
7.24
(0.70)
|
8.15
(1.16)
|
7.46
(0.60)
|
| Week 120 (n=242, 80, 322) |
7.69
(0.75)
|
6.77
(1.10)
|
7.46
(0.63)
|
| Week 144 (n=224, 76, 300) |
7.21
(0.80)
|
6.56
(1.23)
|
7.05
(0.67)
|
| Week 168 (n=213, 70, 283) |
7.38
(0.77)
|
5.42
(1.41)
|
6.90
(0.68)
|
| Week 192 (n=138, 42, 180) |
6.59
(1.01)
|
6.70
(1.57)
|
6.61
(0.86)
|
| Week 216 (n=76, 13, 89) |
6.53
(1.37)
|
4.59
(2.53)
|
6.25
(1.22)
|
| Week 240 (n=65, 5, 70) |
6.13
(1.56)
|
-0.48
(2.86)
|
5.66
(1.48)
|
| Week 264 (n=59, 5, 64) |
6.15
(1.58)
|
0.95
(2.68)
|
5.74
(1.48)
|
| Week 288 (n=3, 0, 3) |
22.27
(5.22)
|
NA
(NA)
|
22.27
(5.22)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
11.40
(0.48)
|
8.13
(0.77)
|
10.40
(0.41)
|
| Week 24 (n=357, 104, 461) |
11.87
(0.50)
|
9.63
(0.79)
|
11.36
(0.43)
|
| Week 48 (n=331, 102, 433) |
12.19
(0.53)
|
10.65
(0.75)
|
11.83
(0.44)
|
| Week 72 (n=315, 99, 414) |
11.96
(0.56)
|
9.92
(0.81)
|
11.47
(0.47)
|
| Week 96 (n=281, 87, 368) |
11.35
(0.59)
|
11.60
(1.04)
|
11.41
(0.51)
|
| Week 120 (n=242, 80, 322) |
11.98
(0.62)
|
10.42
(1.08)
|
11.60
(0.54)
|
| Week 144 (n=224, 76, 300) |
11.51
(0.68)
|
11.15
(1.04)
|
11.42
(0.57)
|
| Week 168 (n=213, 70, 283) |
11.82
(0.65)
|
11.07
(1.11)
|
11.63
(0.56)
|
| Week 192 (n=138, 42, 180) |
11.19
(0.85)
|
11.43
(1.57)
|
11.25
(0.75)
|
| Week 216 (n=76, 13, 89) |
12.43
(1.03)
|
8.52
(2.37)
|
11.86
(0.95)
|
| Week 240 (n=65, 5, 70) |
11.34
(1.04)
|
5.25
(2.63)
|
10.90
(0.99)
|
| Week 264 (n=59, 5, 64) |
11.27
(1.28)
|
4.50
(2.87)
|
10.74
(1.22)
|
| Week 288 (n=3, 0, 3) |
7.08
(5.60)
|
NA
(NA)
|
7.08
(5.60)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
6.07
(0.38)
|
4.24
(0.70)
|
5.67
(0.34)
|
| Week 24 (n=357, 104, 461) |
6.38
(0.39)
|
5.00
(0.58)
|
6.07
(0.33)
|
| Week 48 (n=331, 102, 433) |
6.40
(0.40)
|
5.20
(0.67)
|
6.12
(0.34)
|
| Week 72 (n=315, 99, 414) |
6.29
(0.42)
|
5.35
(0.63)
|
6.06
(0.35)
|
| Week 96 (n=281, 87, 368) |
6.00
(0.45)
|
4.82
(0.73)
|
5.72
(0.38)
|
| Week 120 (n=242, 80, 322) |
5.86
(0.49)
|
5.36
(0.82)
|
5.74
(0.42)
|
| Week 144 (n=224, 76, 300) |
5.37
(0.54)
|
4.38
(0.94)
|
5.12
(0.47)
|
| Week 168 (n=213, 70, 283) |
5.82
(0.53)
|
3.93
(0.87)
|
5.35
(0.46)
|
| Week 192 (n=138, 42, 180) |
4.72
(0.61)
|
4.10
(1.05)
|
4.57
(0.53)
|
| Week 216 (n=76, 13, 89) |
3.73
(0.87)
|
1.59
(1.31)
|
3.42
(0.77)
|
| Week 240 (n=65, 5, 70) |
4.39
(0.96)
|
-1.50
(1.90)
|
3.97
(0.92)
|
| Week 264 (n=59, 5, 64) |
4.12
(1.01)
|
-1.03
(2.17)
|
3.72
(0.96)
|
| Week 288 (n=3, 0, 3) |
-0.94
(4.23)
|
NA
(NA)
|
-0.94
(4.23)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
7.37
(0.59)
|
6.61
(0.90)
|
7.20
(0.50)
|
| Week 24 (n=357, 104, 461) |
7.24
(0.58)
|
6.25
(0.97)
|
7.02
(0.50)
|
| Week 48 (n=331, 102, 433) |
6.83
(0.58)
|
7.22
(0.89)
|
6.92
(0.49)
|
| Week 72 (n=315, 99, 414) |
7.02
(0.61)
|
6.44
(0.98)
|
6.88
(0.52)
|
| Week 96 (n=281, 87, 368) |
6.78
(0.61)
|
6.19
(1.11)
|
6.64
(0.54)
|
| Week 120 (n=242, 80, 322) |
6.49
(0.70)
|
6.96
(1.26)
|
6.61
(0.61)
|
| Week 144 (n=224, 76, 300) |
6.27
(0.75)
|
5.51
(1.15)
|
6.08
(0.63)
|
| Week 168 (n=213, 70, 283) |
6.58
(0.72)
|
4.75
(1.27)
|
6.12
(0.63)
|
| Week 192 (n=138, 42, 180) |
5.40
(0.92)
|
5.70
(1.62)
|
5.47
(0.80)
|
| Week 216 (n=76, 13, 89) |
5.04
(1.18)
|
5.30
(2.47)
|
5.08
(1.07)
|
| Week 240 (n=65, 5, 70) |
5.11
(1.21)
|
-0.60
(3.05)
|
4.70
(1.15)
|
| Week 264 (n=59, 5, 64) |
4.72
(1.17)
|
-1.80
(3.36)
|
4.21
(1.13)
|
| Week 288 (n=3, 0, 3) |
14.97
(8.64)
|
NA
(NA)
|
14.97
(8.64)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
4.99
(0.60)
|
5.17
(1.09)
|
5.03
(0.52)
|
| Week 24 (n=357, 104, 461) |
5.57
(0.62)
|
4.96
(1.25)
|
5.44
(0.56)
|
| Week 48 (n=331, 102, 433) |
5.28
(0.64)
|
5.27
(1.14)
|
5.28
(0.55)
|
| Week 72 (n=315, 99, 414) |
4.81
(0.64)
|
4.78
(1.31)
|
4.81
(0.58)
|
| Week 96 (n=281, 87, 368) |
4.88
(0.67)
|
6.43
(1.19)
|
5.25
(0.58)
|
| Week 120 (n=242, 80, 322) |
5.20
(0.76)
|
5.98
(1.11)
|
5.39
(0.63)
|
| Week 144 (n=224, 76, 300) |
5.23
(0.77)
|
3.33
(1.39)
|
4.75
(0.67)
|
| Week 168 (n=213, 70, 283) |
4.72
(0.79)
|
3.84
(1.43)
|
4.50
(0.69)
|
| Week 192 (n=138, 42, 180) |
4.56
(0.96)
|
5.63
(1.36)
|
4.81
(0.80)
|
| Week 216 (n=76, 13, 89) |
4.53
(1.23)
|
3.31
(2.48)
|
4.35
(1.10)
|
| Week 240 (n=65, 5, 70) |
4.88
(1.41)
|
0.00
(0.00)
|
4.53
(1.32)
|
| Week 264 (n=59, 5, 64) |
4.47
(1.45)
|
-2.15
(2.15)
|
3.95
(1.37)
|
| Week 288 (n=3, 0, 3) |
14.34
(9.49)
|
NA
(NA)
|
14.34
(9.49)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
6.65
(0.65)
|
4.98
(1.19)
|
6.28
(0.57)
|
| Week 24 (n=357, 104, 461) |
6.88
(0.73)
|
4.40
(1.41)
|
6.32
(0.65)
|
| Week 48 (n=331, 102, 433) |
7.26
(0.75)
|
5.49
(1.29)
|
6.85
(0.65)
|
| Week 72 (n=315, 99, 414) |
6.02
(0.78)
|
5.54
(1.28)
|
5.91
(0.67)
|
| Week 96 (n=281, 87, 368) |
6.04
(0.79)
|
5.96
(1.43)
|
6.02
(0.69)
|
| Week 120 (n=242, 80, 322) |
5.68
(0.90)
|
3.98
(1.40)
|
5.26
(0.76)
|
| Week 144 (n=224, 76, 300) |
5.39
(0.96)
|
3.74
(1.56)
|
4.97
(0.82)
|
| Week 168 (n=213, 70, 283) |
5.90
(0.89)
|
4.43
(1.49)
|
5.54
(0.76)
|
| Week 192 (n=138, 42, 180) |
4.31
(1.23)
|
4.42
(1.91)
|
4.33
(1.04)
|
| Week 216 (n=76, 13, 89) |
4.33
(1.55)
|
3.49
(2.76)
|
4.21
(1.38)
|
| Week 240 (n=65, 5, 70) |
4.72
(1.66)
|
-0.76
(4.22)
|
4.33
(1.58)
|
| Week 264 (n=59, 5, 64) |
5.07
(1.74)
|
-0.76
(4.22)
|
4.61
(1.64)
|
| Week 288 (n=3, 0, 3) |
22.71
(5.78)
|
NA
(NA)
|
22.71
(5.78)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
6.27
(0.63)
|
5.38
(1.04)
|
6.08
(0.54)
|
| Week 24 (n=357, 104, 461) |
6.22
(0.65)
|
3.84
(1.17)
|
5.69
(0.57)
|
| Week 48 (n=331, 102, 433) |
5.73
(0.64)
|
5.35
(1.02)
|
5.64
(0.54)
|
| Week 72 (n=315, 99, 414) |
4.77
(0.70)
|
5.48
(1.04)
|
4.94
(0.59)
|
| Week 96 (n=281, 87, 368) |
5.23
(0.68)
|
5.89
(1.14)
|
5.38
(0.59)
|
| Week 120 (n=242, 80, 322) |
5.56
(0.77)
|
5.26
(1.31)
|
5.49
(0.67)
|
| Week 144 (n=224, 76, 300) |
5.10
(0.84)
|
4.37
(1.34)
|
4.91
(0.71)
|
| Week 168 (n=213, 70, 283) |
5.12
(0.76)
|
3.76
(1.29)
|
4.79
(0.66)
|
| Week 192 (n=138, 42, 180) |
3.77
(0.93)
|
5.21
(1.75)
|
4.11
(0.82)
|
| Week 216 (n=76, 13, 89) |
2.66
(1.21)
|
4.26
(3.04)
|
2.89
(1.12)
|
| Week 240 (n=65, 5, 70) |
3.75
(1.20)
|
3.32
(2.04)
|
3.72
(1.12)
|
| Week 264 (n=59, 5, 64) |
4.18
(1.34)
|
0.00
(1.75)
|
3.85
(1.25)
|
| Week 288 (n=3, 0, 3) |
14.78
(7.56)
|
NA
(NA)
|
14.78
(7.56)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
8.44
(0.39)
|
6.09
(0.68)
|
7.92
(0.34)
|
| Week 24 (n=357, 104, 461) |
9.39
(0.38)
|
7.56
(0.70)
|
8.98
(0.34)
|
| Week 48 (n=331, 102, 433) |
9.75
(0.43)
|
8.24
(0.72)
|
9.39
(0.37)
|
| Week 72 (n=315, 99, 414) |
9.72
(0.43)
|
8.21
(0.76)
|
9.36
(0.37)
|
| Week 96 (n=281, 87, 368) |
9.35
(0.48)
|
8.93
(0.77)
|
9.25
(0.41)
|
| Week 120 (n=242, 80, 322) |
9.66
(0.49)
|
8.79
(0.92)
|
9.45
(0.43)
|
| Week 144 (n=224, 76, 300) |
9.26
(0.54)
|
8.60
(0.92)
|
9.09
(0.47)
|
| Week 168 (n=213, 70, 283) |
9.51
(0.54)
|
7.86
(1.03)
|
9.10
(0.48)
|
| Week 192 (n=138, 42, 180) |
9.51
(0.65)
|
8.56
(1.18)
|
9.29
(0.57)
|
| Week 216 (n=76, 13, 89) |
9.59
(0.88)
|
5.37
(1.93)
|
8.97
(0.82)
|
| Week 240 (n=65, 5, 70) |
9.00
(0.93)
|
1.91
(2.87)
|
8.49
(0.91)
|
| Week 264 (n=59, 5, 64) |
8.72
(1.03)
|
2.31
(2.27)
|
8.22
(0.99)
|
| Week 288 (n=3, 0, 3) |
6.87
(1.88)
|
NA
(NA)
|
6.87
(1.88)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS). |
| Time Frame | Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Week 12 (n=370, 105, 475) |
5.13
(0.63)
|
4.82
(1.01)
|
5.06
(0.54)
|
| Week 24 (n=357, 104, 461) |
4.95
(0.67)
|
3.38
(1.26)
|
4.60
(0.59)
|
| Week 48 (n=331, 102, 433) |
4.56
(0.66)
|
4.45
(1.06)
|
4.54
(0.56)
|
| Week 72 (n=315, 99, 414) |
3.63
(0.69)
|
4.15
(1.14)
|
3.75
(0.59)
|
| Week 96 (n=281, 87, 368) |
3.88
(0.68)
|
4.53
(1.25)
|
4.03
(0.60)
|
| Week 120 (n=242, 80, 322) |
3.79
(0.80)
|
3.68
(1.37)
|
3.76
(0.69)
|
| Week 144 (n=224, 76, 300) |
3.57
(0.84)
|
2.24
(1.40)
|
3.23
(0.72)
|
| Week 168 (n=213, 70, 283) |
3.64
(0.80)
|
2.45
(1.41)
|
3.35
(0.70)
|
| Week 192 (n=138, 42, 180) |
2.05
(0.99)
|
3.44
(1.80)
|
2.38
(0.86)
|
| Week 216 (n=76, 13, 89) |
1.49
(1.29)
|
3.14
(3.04)
|
1.73
(1.18)
|
| Week 240 (n=65, 5, 70) |
2.41
(1.27)
|
-0.04
(1.81)
|
2.23
(1.19)
|
| Week 264 (n=59, 5, 64) |
2.59
(1.42)
|
-2.25
(1.41)
|
2.21
(1.32)
|
| Week 288 (n=3, 0, 3) |
18.64
(4.01)
|
NA
(NA)
|
18.64
(4.01)
|
| Title | Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS) |
|---|---|
| Description | mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study. |
| Time Frame | First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who had completed Study A3921044 among all participants who received at least 1 dose of study medication in current study. No imputation was used (observed data). |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 75 | 7 | 82 |
| Week 24 (n=69, 7, 76) |
0.17
(0.09)
|
0.50
(0.22)
|
0.20
(0.08)
|
| Week 48 (n=64, 7, 71) |
0.27
(0.17)
|
1.75
(1.16)
|
0.41
(0.19)
|
| Week 96 (n=39, 1, 40) |
0.40
(0.21)
|
1.00
(NA)
|
0.42
(0.20)
|
| Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation. |
| Time Frame | Baseline up to Week 288 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: all participants who received at least 1 dose of study medication in current study. |
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total |
|---|---|---|---|
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. |
| Measure Participants | 381 | 105 | 486 |
| Number of participants with AEs (including SAEs) |
371
|
105
|
476
|
| Number of participants with SAEs |
111
|
28
|
139
|
Adverse Events
| Time Frame | Safety observations up to Week 288 | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||
| Arm/Group Title | CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total | |||
| Arm/Group Description | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID. | CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID. | All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient's condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total. | |||
All Cause Mortality |
||||||
| CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 111/381 (29.1%) | 28/105 (26.7%) | 139/486 (28.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Disseminated intravascular coagulation | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Thrombotic thrombocytopenic purpura | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Cardiac disorders | ||||||
| Acute coronary syndrome | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Angina pectoris | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Prinzmetal angina | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Ventricular fibrillation | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Vertigo positional | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Endocrine disorders | ||||||
| Hyperparathyroidism primary | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Eye disorders | ||||||
| Cataract | 2/381 (0.5%) | 1/105 (1%) | 3/486 (0.6%) | |||
| Dacryostenosis acquired | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Retinal artery occlusion | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Retinal detachment | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Gastrointestinal disorders | ||||||
| Colitis ischaemic | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Gastric polyps | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Gastric ulcer haemorrhage | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Ileus | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Inguinal hernia | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Large intestine polyp | 3/381 (0.8%) | 0/105 (0%) | 3/486 (0.6%) | |||
| Radicular cyst | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| General disorders | ||||||
| Chest pain | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Device material issue | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Submandibular mass | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Hepatobiliary disorders | ||||||
| Cholecystitis chronic | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Cholelithiasis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Liver disorder | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Infections and infestations | ||||||
| Appendicitis | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Bronchitis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Cellulitis | 3/381 (0.8%) | 1/105 (1%) | 4/486 (0.8%) | |||
| Chronic sinusitis | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Diverticulitis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Enteritis infectious | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Enterocolitis infectious | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Enterocolitis viral | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Gastroenteritis | 2/381 (0.5%) | 1/105 (1%) | 3/486 (0.6%) | |||
| Herpes zoster | 11/381 (2.9%) | 2/105 (1.9%) | 13/486 (2.7%) | |||
| Herpes zoster disseminated | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Mycobacterium avium complex infection | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Nasopharyngitis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Pneumocystis jirovecii pneumonia | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Pneumonia | 6/381 (1.6%) | 1/105 (1%) | 7/486 (1.4%) | |||
| Pneumonia bacterial | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Pneumonia haemophilus | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Pneumonia mycoplasmal | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Pulmonary tuberculosis | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Pyelonephritis | 3/381 (0.8%) | 2/105 (1.9%) | 5/486 (1%) | |||
| Sepsis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Septic shock | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Urinary tract infection | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Injury, poisoning and procedural complications | ||||||
| Ankle fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Compression fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Contusion | 3/381 (0.8%) | 0/105 (0%) | 3/486 (0.6%) | |||
| Femoral neck fracture | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Femur fracture | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Hand fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Humerus fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Joint dislocation | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Patella fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Post procedural haemorrhage | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Pubis fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Radius fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Tendon rupture | 9/381 (2.4%) | 0/105 (0%) | 9/486 (1.9%) | |||
| Tibia fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Ulna fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Upper limb fracture | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Computerised tomogram thorax abnormal | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Hypokalaemia | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthropathy | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Foot deformity | 1/381 (0.3%) | 1/105 (1%) | 2/486 (0.4%) | |||
| Intervertebral disc protrusion | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Joint destruction | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Kyphosis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Lumbar spinal stenosis | 0/381 (0%) | 4/105 (3.8%) | 4/486 (0.8%) | |||
| Neck pain | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Osteoarthritis | 2/381 (0.5%) | 1/105 (1%) | 3/486 (0.6%) | |||
| Osteonecrosis | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Periostitis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Rheumatoid arthritis | 3/381 (0.8%) | 1/105 (1%) | 4/486 (0.8%) | |||
| Spinal column stenosis | 3/381 (0.8%) | 0/105 (0%) | 3/486 (0.6%) | |||
| Spondylolisthesis | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Acute myeloid leukaemia | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Adenocarcinoma gastric | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Breast cancer | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Colon adenoma | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Colon cancer | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Colorectal adenocarcinoma | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Fallopian tube cancer | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Gastric cancer | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Haemangioma | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Liposarcoma | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Lymphoproliferative disorder | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Malignant ascites | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Malignant pleural effusion | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Metastases to liver | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Metastases to lung | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Metastases to lymph nodes | 3/381 (0.8%) | 0/105 (0%) | 3/486 (0.6%) | |||
| Metastases to peritoneum | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Neuroendocrine carcinoma of the skin | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Oesophageal carcinoma | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Ovarian cancer | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Ovarian cancer metastatic | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Ovarian germ cell teratoma benign | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Paget's disease of nipple | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Peritoneal neoplasm | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Small cell lung cancer | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Squamous cell carcinoma of lung | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Transitional cell carcinoma | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Uterine leiomyoma | 2/381 (0.5%) | 0/105 (0%) | 2/486 (0.4%) | |||
| Nervous system disorders | ||||||
| Carpal tunnel syndrome | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Cerebral haemorrhage | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Cerebral infarction | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Cerebral thrombosis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Convulsion | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Cubital tunnel syndrome | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| IIIrd nerve paralysis | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Lacunar infarction | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
| Loss of consciousness | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Spondylitic myelopathy | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Temporal lobe epilepsy | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Transient global amnesia | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Renal and urinary disorders | ||||||
| Calculus ureteric | 1/381 (0.3%) | 1/105 (1%) | 2/486 (0.4%) | |||
| Glomerulonephritis membranous | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Reproductive system and breast disorders | ||||||
| Uterine polyp | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Interstitial lung disease | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Organising pneumonia | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Pleurisy | 1/381 (0.3%) | 0/105 (0%) | 1/486 (0.2%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Skin ulcer | 0/381 (0%) | 1/105 (1%) | 1/486 (0.2%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| CP-690,550 5 mg BID | CP-690,550 10 mg BID | Total | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 345/381 (90.6%) | 101/105 (96.2%) | 446/486 (91.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 14/381 (3.7%) | 11/105 (10.5%) | 25/486 (5.1%) | |||
| Eye disorders | ||||||
| Conjunctivitis | 17/381 (4.5%) | 6/105 (5.7%) | 23/486 (4.7%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 13/381 (3.4%) | 6/105 (5.7%) | 19/486 (3.9%) | |||
| Constipation | 34/381 (8.9%) | 9/105 (8.6%) | 43/486 (8.8%) | |||
| Dental caries | 39/381 (10.2%) | 15/105 (14.3%) | 54/486 (11.1%) | |||
| Diarrhoea | 28/381 (7.3%) | 5/105 (4.8%) | 33/486 (6.8%) | |||
| Gastritis | 22/381 (5.8%) | 4/105 (3.8%) | 26/486 (5.3%) | |||
| Stomatitis | 25/381 (6.6%) | 7/105 (6.7%) | 32/486 (6.6%) | |||
| General disorders | ||||||
| Pyrexia | 15/381 (3.9%) | 9/105 (8.6%) | 24/486 (4.9%) | |||
| Infections and infestations | ||||||
| Bronchitis | 45/381 (11.8%) | 5/105 (4.8%) | 50/486 (10.3%) | |||
| Cystitis | 39/381 (10.2%) | 7/105 (6.7%) | 46/486 (9.5%) | |||
| Gastroenteritis | 34/381 (8.9%) | 11/105 (10.5%) | 45/486 (9.3%) | |||
| Gingivitis | 10/381 (2.6%) | 7/105 (6.7%) | 17/486 (3.5%) | |||
| Herpes zoster | 59/381 (15.5%) | 22/105 (21%) | 81/486 (16.7%) | |||
| Influenza | 37/381 (9.7%) | 11/105 (10.5%) | 48/486 (9.9%) | |||
| Nasopharyngitis | 221/381 (58%) | 72/105 (68.6%) | 293/486 (60.3%) | |||
| Oral herpes | 26/381 (6.8%) | 7/105 (6.7%) | 33/486 (6.8%) | |||
| Periodontitis | 20/381 (5.2%) | 3/105 (2.9%) | 23/486 (4.7%) | |||
| Pharyngitis | 36/381 (9.4%) | 10/105 (9.5%) | 46/486 (9.5%) | |||
| Tinea pedis | 31/381 (8.1%) | 3/105 (2.9%) | 34/486 (7%) | |||
| Upper respiratory tract infection | 40/381 (10.5%) | 8/105 (7.6%) | 48/486 (9.9%) | |||
| Injury, poisoning and procedural complications | ||||||
| Contusion | 36/381 (9.4%) | 12/105 (11.4%) | 48/486 (9.9%) | |||
| Fall | 51/381 (13.4%) | 20/105 (19%) | 71/486 (14.6%) | |||
| Ligament sprain | 11/381 (2.9%) | 9/105 (8.6%) | 20/486 (4.1%) | |||
| Road traffic accident | 9/381 (2.4%) | 8/105 (7.6%) | 17/486 (3.5%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 25/381 (6.6%) | 1/105 (1%) | 26/486 (5.3%) | |||
| Aspartate aminotransferase increased | 22/381 (5.8%) | 1/105 (1%) | 23/486 (4.7%) | |||
| Blood cholesterol increased | 9/381 (2.4%) | 6/105 (5.7%) | 15/486 (3.1%) | |||
| Low density lipoprotein increased | 17/381 (4.5%) | 6/105 (5.7%) | 23/486 (4.7%) | |||
| Lymphocyte count decreased | 29/381 (7.6%) | 9/105 (8.6%) | 38/486 (7.8%) | |||
| White blood cell count decreased | 17/381 (4.5%) | 10/105 (9.5%) | 27/486 (5.6%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypercholesterolaemia | 13/381 (3.4%) | 6/105 (5.7%) | 19/486 (3.9%) | |||
| Hyperlipidaemia | 36/381 (9.4%) | 20/105 (19%) | 56/486 (11.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 43/381 (11.3%) | 3/105 (2.9%) | 46/486 (9.5%) | |||
| Rheumatoid arthritis | 6/381 (1.6%) | 7/105 (6.7%) | 13/486 (2.7%) | |||
| Nervous system disorders | ||||||
| Headache | 38/381 (10%) | 10/105 (9.5%) | 48/486 (9.9%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 24/381 (6.3%) | 9/105 (8.6%) | 33/486 (6.8%) | |||
| Oropharyngeal pain | 19/381 (5%) | 4/105 (3.8%) | 23/486 (4.7%) | |||
| Upper respiratory tract inflammation | 25/381 (6.6%) | 9/105 (8.6%) | 34/486 (7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Eczema | 25/381 (6.6%) | 2/105 (1.9%) | 27/486 (5.6%) | |||
| Rash | 17/381 (4.5%) | 6/105 (5.7%) | 23/486 (4.7%) | |||
| Vascular disorders | ||||||
| Hypertension | 40/381 (10.5%) | 15/105 (14.3%) | 55/486 (11.3%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00661661
Other Study ID Numbers:
- A3921041
First Posted:
Apr 18, 2008
Last Update Posted:
May 12, 2015
Last Verified:
Apr 1, 2015