Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 309
Healthy volunteers: no

Brief summary:
This study will investigate the efficacy of both low and high doses of methotrexate (MTX) in combination with open-label adalimumab (ADA) in patients who have had an inadequate response to high dose of MTX. The study will also evaluate the pharmacokinetics and safety of the two regimens of MTX in combination with ADA in participants with rheumatoid arthritis (RA).

Detailed description:

Arms:
arm 1: Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly). arm 2: Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).

Interventions: intervention 1: Adalimumab intervention 2: Methotrexate
Intervention descriptions: intervention 1: Adalimumab in pre-filled syringes intervention 2: Methotrexate capsule

Protocol document: