Conditions: Rheumatoid Arthritis (RA)
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 119
Healthy volunteers: no

Brief summary:
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

Detailed description:

Arms:
arm 1: In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. arm 2: In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.

Interventions: intervention 1: abatacept intervention 2: Methotrexate (MTX)
Intervention descriptions: intervention 1: solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open intervention 2: Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks

Protocol document: