Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1286
Healthy volunteers: no

Brief summary:
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

Detailed description:

Arms:
arm 1: In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. arm 2: In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. arm 3: Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.

Interventions: intervention 1: Abatacept intervention 2: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) intervention 3: Anti-Tumor Necrosing Factor (TNF) Therapy
Intervention descriptions: intervention 1: IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months. intervention 2: During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1). intervention 3: Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months

Protocol document: