Clinical trial NCT00048568: A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-11-13
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.


Eligibility 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.

Primary outcomes:
measure: Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169
timeFrame: Day 169
measure: Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365
timeFrame: Day 365
measure: Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365
timeFrame: BL (Day 0), Day 365
measure: Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period
timeFrame: Day 365 to Day 2,185
measure: Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period
timeFrame: Day 365 to Day 2,185
measure: Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period
timeFrame: Day 365 to Day 2,185
measure: Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period
timeFrame: Day 365 to Day 2,185
measure: Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period
timeFrame: Day 365 to Day 2,185
measure: Mean BL Immunoglobulins Over Time in the OL Period
timeFrame: BL (Day 0), Day 365, Day 729, Day 1,093
measure: Mean Change From BL in Immunoglobulins in the OL Period
timeFrame: BL (Day 0), Day 365, Day 729, Day 1,093
measure: Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period
timeFrame: Day 1 to Day 1,821
measure: Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period
timeFrame: 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.
measure: Number of Participants Experiencing AEs of Special Interest in the OL Period
timeFrame: Day 365 to Day 2,185
measure: Mean BL Hematocrit in the OL Period
timeFrame: 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
measure: Mean Change From BL in Participant Hematocrit in the OL Period
timeFrame: 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
measure: Mean BL Platelet Count in the OL Period
timeFrame: 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
measure: Mean Change From BL in Participant Platelet Count in the OL Period
timeFrame: 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
measure: Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period
timeFrame: 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
measure: Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period
timeFrame: 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
measure: Mean BL White Blood Cells in the OL Period
timeFrame: 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
measure: Mean Change From BL in White Blood Cells in the OL Period
timeFrame: 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
measure: Mean BL Liver Function Parameters in the OL Period
timeFrame: 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
measure: Mean Change From BL in Liver Function Parameters in the OL Period
timeFrame: 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
measure: Mean BL Select Laboratory Parameters in the OL Period
timeFrame: 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
measure: Mean Change From BL in Select Laboratory Parameters in the OL Period
timeFrame: 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
measure: Mean BL Serum Electrolytes in the OL Period
timeFrame: 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
measure: Mean Change From BL in Serum Electrolytes in the OL Period
timeFrame: 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
Secondary outcomes:
measure: Mean Number of Tender Joints and Swollen Joints at DB BL
timeFrame: BL (Day 0)
measure: Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment
timeFrame: BL (Day 0)
measure: BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period
timeFrame: BL (Day 365)
measure: ACR 20 Responders at Day 365
timeFrame: Day 365
measure: ACR 20 Responders in the Double-Blind (DB) Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR 50 Responders at Day 169
timeFrame: Day 169
measure: ACR 50 Responders at Day 365
timeFrame: Day 365
measure: ACR 50 Responders in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR 70 Responders at Day 169
timeFrame: Day 169
measure: ACR 70 Responders at Day 365
timeFrame: Day 365
measure: ACR 70 Responders in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: Number of Participants Achieving Major Clinical Response By Day 365
timeFrame: 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.
measure: Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365
timeFrame: BL (Day 0), Day 169, Day 365, Day 169, Day 365
measure: 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
timeFrame: Day 1 to Day 365
measure: Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)
timeFrame: BL (Day 0), Day 365
measure: Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)
timeFrame: BL (Day 0), Day 169, Day 365
measure: Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Participants in the DB Period Achieving an Extended Major Clinical Response
timeFrame: Day 1 to Day 365
measure: Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period
timeFrame: Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365
measure: Number of Participants Discontinuing in the DB Period
timeFrame: Day 1 to Day 169, Day 170 to Day 365
measure: Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period
timeFrame: BL (Day 0), Day 365
measure: Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period
timeFrame: Day 1 to Day 365
measure: Participants Experiencing AEs of Special Interest in the DB Period
timeFrame: Day 1 to Day 365
measure: Mean BL Individual Components of the HAQ DI at Day 169 and Day 365
timeFrame: BL (Day 0), Day 169, Day 365
measure: Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169
timeFrame: Day 169
measure: Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365
timeFrame: Day 365
measure: Number of Participants With Immunogenicity to Abatacept in the DB Period
timeFrame: Day 1 to Day 365
measure: Number of New Tender Joints and Number of New Swollen Joints in the DB Period
timeFrame: Day 169, Day 365
measure: Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period
timeFrame: Day 169, Day 365
measure: Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period
timeFrame: Day 1 to Day 365
measure: Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period
timeFrame: Day 1 to Day 365
measure: Mean BL ESR and CRP Levels in the OL Period
timeFrame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185
measure: Mean Change From BL in ESR in the OL Period
timeFrame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185
measure: Participant RF Seroconversion in the OL Period
timeFrame: Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185
measure: Number of ACR 20 Responders in the DB and OL Periods
timeFrame: 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
measure: Number of ACR 50 Responders in the DB and OL Periods
timeFrame: 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
measure: Number of ACR 70 Responders in the DB and OL Periods
timeFrame: 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
measure: Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time
timeFrame: 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
measure: Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period
timeFrame: 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
measure: Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period
timeFrame: 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
measure: Mean BL DAS-28 ESR Over Time in the OL Period
timeFrame: 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
measure: Mean Change From BL in DAS-28 ESR Over Time in the OL Period
timeFrame: 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
measure: Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period
timeFrame: 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
measure: BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period
timeFrame: BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821
measure: Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Physical Function Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL General Health Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Vitality Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Mental Health Component of the SF-36 by Visit in the OL Period
timeFrame: 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
measure: Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period
timeFrame: 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
measure: Mean BL Fatigue in the OL Period
timeFrame: 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
measure: Mean Change From BL in Fatigue in the OL Period
timeFrame: 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
measure: Mean BL Sleep Quality in the OL Period
timeFrame: 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
measure: Mean Change From BL in Sleep Quality in the OL Period
timeFrame: 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
measure: Mean BL Limitations on Activities of Daily Living in the OL Period
timeFrame: 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
measure: Mean Change From BL in Limitations on Activities of Daily Living in the OL Period
timeFrame: 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
measure: Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Mean Change From BL in RF in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period
timeFrame: BL (Day 0), Day 169, Day 365
measure: 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
timeFrame: BL (Day 0), Day 365
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 365
measure: 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
timeFrame: BL (Day 0), Day 449
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 449
measure: 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
timeFrame: BL (Day 0), Day 533
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 533
measure: 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
timeFrame: BL (Day 0), Day 617
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 617
measure: 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
timeFrame: BL (Day 0), Day 729
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 729
measure: 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
timeFrame: BL (Day 0), Day 813
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 813
measure: 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
timeFrame: BL (Day 0), Day 897
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 897
measure: 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
timeFrame: BL (Day 0), Day 981
measure: Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period
timeFrame: BL (Day 0), Day 981
measure: 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
timeFrame: BL (Day 0), Day 1,093
measure: 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
timeFrame: BL (Day 0), Day 1,093
measure: 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
timeFrame: BL (Day 0), Day 1,177
measure: 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
timeFrame: BL (Day 0), Day 1,177
measure: 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
timeFrame: BL (Day 0), Day 1,261
measure: 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
timeFrame: BL (Day 0), Day 1,261
measure: 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
timeFrame: BL (Day 0), Day 1,345
measure: 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
timeFrame: BL (Day 0), Day 1,345
measure: 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
timeFrame: BL (Day 0), Day 1,457
measure: 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
timeFrame: BL (Day 0), Day 1,457
measure: 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
timeFrame: BL (Day 0), Day 1,625
measure: 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
timeFrame: BL (Day 0), Day 1,625
measure: 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
timeFrame: BL (Day 0), Day 1,821
measure: 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
timeFrame: BL (Day 0), Day 1,821
measure: 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
timeFrame: BL (Day 0), Day 1,989
measure: 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
timeFrame: BL (Day 0), Day 1,989
measure: 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
timeFrame: BL (Day 0), Day 2,185
measure: 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
timeFrame: BL (Day 0), Day 2,185
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Huntsville
country: United States
facility: Local Institution
state: Alabama
city: Mobile
country: United States
facility: Local Institution
state: Alabama
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Scottsdale
country: United States
facility: Local Institution
state: Arizona
city: Corona
country: United States
facility: Local Institution
state: California
city: Irvine
country: United States
facility: Local Institution
state: California
city: La Jolla
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Rancho Mirage
country: United States
facility: Local Institution
state: California
city: Aurora
country: United States
facility: Local Institution
state: Colorado
city: Colorado Springs
country: United States
facility: Local Institution
state: Colorado
city: Denver
country: United States
facility: Local Institution
state: Colorado
city: Hamden
country: United States
facility: Local Institution
state: Connecticut
city: Washington
country: United States
facility: Local Institution
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Local Institution
state: Florida
city: Gainsville
country: United States
facility: Local Institution
state: Florida
city: Palm Harbor
country: United States
facility: Local Institution
state: Florida
city: Sarasota
country: United States
facility: Local Institution
state: Florida
city: St. Petersburg
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Rockford
country: United States
facility: Local Institution
state: Illinois
city: Wichita
country: United States
facility: Local Institution
state: Kansas
city: Coeur d'Alene
country: United States
facility: Local Institution
state: Maryland
city: Cumberland
country: United States
facility: Local Institution
state: Maryland
city: Springfield
country: United States
facility: Local Institution
state: Massachusetts
city: Duluth
country: United States
facility: Local Institution
state: Minnesota
city: Lincoln
country: United States
facility: Local Institution
state: Nebraska
city: New Brunswick
country: United States
facility: Local Institution
state: New Jersey
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: Albany
country: United States
facility: Local Institution
state: New York
city: Binghamton
country: United States
facility: Local Institution
state: New York
city: Bronx
country: United States
facility: Local Institution
state: New York
city: Mineola
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Syracuse
country: United States
facility: Local Institution
state: New York
city: Wilmington
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Duncansville
country: United States
facility: Local Institution
state: Pennsylvania
city: Norristown
country: United States
facility: Local Institution
state: Pennsylvania
city: Sellersville
country: United States
facility: Local Institution
state: Pennsylvania
city: Willow Grove
country: United States
facility: Local Institution
state: Pennsylvania
city: North Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Austin
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Arlington
country: United States
facility: Local Institution
state: Virginia
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
References:
citation: Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Ge Z, Becker JC, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006 Jun 20;144(12):865-76. doi: 10.7326/0003-4819-144-12-200606200-00003.
citation: Kremer JM, Peterfy C, Russell AS, Emery P, Abud-Mendoza C, Sibilia J, Becker JC, Westhovens R, Genant HK. Longterm safety, efficacy, and inhibition of structural damage progression over 5 years of treatment with abatacept in patients with rheumatoid arthritis in the abatacept in inadequate responders to methotrexate trial. J Rheumatol. 2014 Jun;41(6):1077-87. doi: 10.3899/jrheum.130263. Epub 2014 May 1.
citation: Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Teng J, Becker JC, Westhovens R. Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum. 2008 Apr;58(4):953-63. doi: 10.1002/art.23397.