Conditions: Early Rheumatoid Arthritis
Keywords: Arthritis Erosion Humira Adalimumab Injection Rheumatoid Methotrexate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 395
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).

Detailed description:

Arms:
arm 1: 2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks arm 2: 5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks arm 3: 10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks arm 4: MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks

Interventions: intervention 1: adalimumab intervention 2: methotrexate
Intervention descriptions: intervention 1: Pre-filled syringe every other week intervention 2: weekly oral capsule dosing

Protocol document: