Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1250
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Short Term: Abatacept was dosed by weight with participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) either orally or parenterally at a minimum dose of 15 mg. arm 2: Short Term: Participants received a placebo solution intravenously and methotrexate at the dose employed prior to study enrollment and a minimum of 15 mg. arm 3: Open Label: Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.

Interventions: intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Placebo
Intervention descriptions: intervention 1: Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year intervention 2: Tablets, Oral, \>= 15 mg, weekly, 1 year intervention 3: IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year

Protocol document: