A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study

简要总结

主要结局

次要结局

• Number of Participants Experiencing Disease Relapse(After 12 Months of treatment)
• Mean Time-Matched Baseline DAS28 CRP Scores(Baseline)
• Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment(Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365)
• Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)(After 12 months of treatment)
• Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment(After 12 months of treatment)
• Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids(After 12 months of treatment)
• Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment(After 12 months of treatment)
• Percentage of Participants Who Modified Therapy During Double-Blind Treatment(After 12 months of treatment)
• Percentage of Participants Who Lost Remission Status(After 12 months of treatment)
• Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment(Day 701 of the main study; sub-study Days 1, 85, 169, 253)
• Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Clinically Significant Changes in Vital Signs and Physical Findings(From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks))
• Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment(After 12 months of treatment)