Rheumatoid Arthritis Clinical Trial
The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.
This was a multinational, multicenter, randomized, double-blind, 2-arm, parallel-dosing
designed study. The treatment period was 12 months. Eligible participants were randomized to
1 of 2 treatment groups: abatacept fixed dose approximating 10 mg/kg (based on participant's
body weight; 500 mg for participants weighing < 60kg; 750 mg for participants weighing 60 to
100 kg; and 1 gram for participants weighing > 100 kg, monthly) or placebo intravenous (IV)
infusion. All participants continued their background therapy(ies) for rheumatoid arthritis
(RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout
the double-blind treatment period. Double-blind study medication (abatacept or placebo) was
administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses.
All participants who completed the 12-month double-blind study period (Day 1 through Day
365), were eligible to continue into the open-label period. All eligible participants
(active or placebo) were re-allocated to receive abatacept at a weight-tiered dose that
approximated 10 mg/kg, based on their Day 365 body weight. Participants continued to receive
infusions every 28 days.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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