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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00048568
Date of registration: 02/11/2002
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Scientific title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Date of first enrolment: December 2002
Target sample size: 1250
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00048568
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

- Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis
of RA.

- Participants must have been taking methotrexate for at least 3 months with at least a
weekly dose of 15 mg.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Methotrexate
Drug: Placebo
Primary Outcome(s)
Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 [Time Frame: BL (Day 0), Day 365]
Mean BL Hematocrit in the OL Period [Time Frame: Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean BL Immunoglobulins Over Time in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093]
Mean BL Liver Function Parameters in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean BL Platelet Count in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean BL Select Laboratory Parameters in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean BL Serum Electrolytes in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean BL White Blood Cells in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean Change From BL in Immunoglobulins in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093]
Mean Change From BL in Liver Function Parameters in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean Change From BL in Participant Hematocrit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean Change From BL in Participant Platelet Count in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean Change From BL in Select Laboratory Parameters in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean Change From BL in Serum Electrolytes in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Mean Change From BL in White Blood Cells in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185]
Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 [Time Frame: Day 169]
Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365 [Time Frame: Day 365]
Number of Participants Experiencing AEs of Special Interest in the OL Period [Time Frame: Day 365 to Day 2,185]
Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period [Time Frame: Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.]
Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period [Time Frame: Day 365 to Day 2,185]
Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period [Time Frame: Day 365 to Day 2,185]
Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period [Time Frame: Day 365 to Day 2,185]
Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period [Time Frame: Day 365 to Day 2,185]
Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period [Time Frame: Day 1 to Day 1,821]
Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period [Time Frame: Day 365 to Day 2,185]
Secondary Outcome(s)
ACR 20 Responders at Day 365 [Time Frame: Day 365]
ACR 20 Responders in the Double-Blind (DB) Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR 50 Responders at Day 169 [Time Frame: Day 169]
ACR 50 Responders at Day 365 [Time Frame: Day 365]
ACR 50 Responders in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR 70 Responders at Day 169 [Time Frame: Day 169]
ACR 70 Responders at Day 365 [Time Frame: Day 365]
ACR 70 Responders in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365]
Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169 [Time Frame: Day 169]
Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365 [Time Frame: Day 365]
Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821]
BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period [Time Frame: BL (Day 365)]
Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period [Time Frame: BL (Day 0), Day 365]
Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365 [Time Frame: BL (Day 0), Day 169, Day 365, Day 169, Day 365]
Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period [Time Frame: BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL DAS-28 ESR Over Time in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean BL ESR and CRP Levels in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185]
Mean BL Fatigue in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL General Health Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 365]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 449]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 533]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,093]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,177]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,261]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,345]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,457]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,625]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,821]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,989]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 2,185]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 617]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 729]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 813]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 897]
Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 981]
Mean BL Individual Components of the HAQ DI at Day 169 and Day 365 [Time Frame: BL (Day 0), Day 169, Day 365]
Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean BL Limitations on Activities of Daily Living in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457]
Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Mental Health Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Physical Function Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Sleep Quality in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean BL Vitality Component of the SF-36 by Visit in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period [Time Frame: BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL in DAS-28 ESR Over Time in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean Change From BL in ESR in the OL Period [Time Frame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL in Fatigue in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,093]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,177]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,261]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,345]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,457]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,625]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,821]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 1,989]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 2,185]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 365]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 449]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 533]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 617]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 729]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 813]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 897]
Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period [Time Frame: BL (Day 0), Day 981]
Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean Change From BL in Limitations on Activities of Daily Living in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457]
Mean Change From BL in RF in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean Change From BL in Sleep Quality in the OL Period [Time Frame: BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period [Time Frame: BL (Day 0), Day 169, Day 365]
Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS) [Time Frame: BL (Day 0), Day 365]
Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment [Time Frame: BL (Day 0)]
Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36) [Time Frame: BL (Day 0), Day 169, Day 365]
Mean Number of Tender Joints and Swollen Joints at DB BL [Time Frame: BL (Day 0)]
Number of ACR 20 Responders in the DB and OL Periods [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]
Number of ACR 50 Responders in the DB and OL Periods [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]
Number of ACR 70 Responders in the DB and OL Periods [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]
Number of New Tender Joints and Number of New Swollen Joints in the DB Period [Time Frame: Day 169, Day 365]
Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821]
Number of Participants Achieving Major Clinical Response By Day 365 [Time Frame: Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.]
Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time [Time Frame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185]
Number of Participants Discontinuing in the DB Period [Time Frame: Day 1 to Day 169, Day 170 to Day 365]
Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period [Time Frame: Day 169, Day 365]
Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period [Time Frame: Day 1 to Day 365]
Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period [Time Frame: Day 1 to Day 365]
Number of Participants With Immunogenicity to Abatacept in the DB Period [Time Frame: Day 1 to Day 365]
Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period [Time Frame: Day 1 to Day 365]
Participant RF Seroconversion in the OL Period [Time Frame: Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185]
Participants Experiencing AEs of Special Interest in the DB Period [Time Frame: Day 1 to Day 365]
Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period [Time Frame: Day 1 to Day 365]
Participants in the DB Period Achieving an Extended Major Clinical Response [Time Frame: Day 1 to Day 365]
Secondary ID(s)
IM101-102
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 05/12/2011
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00048568
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