Rheumatoid Arthritis Clinical Trial
Official title:
A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.
All participants who completed the 12-month double-blind study period were eligible to
continue in the open-label study. Participants received placebo, Abatacept 2 mg/kg, or
Abatacept 10 mg/kg in the double-blind study. Participants receiving placebo in the
double-blind study were switched 1:1 to continued treatment with placebo or Abatacept 2
mg/kg. Participants receiving Abatacept 2 mg/kg or Abatacept 10 mg/kg continued at the
double-blind study dosage. After results from the double-blind period became available, all
participants were switched to a weight-tiered 10 mg/kg dose of Abatacept.
Open label study design: Single group assignment, Single arm, Open label,
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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