Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 420
Healthy volunteers: no

Brief summary:
To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

Detailed description:
The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.

Arms:
arm 1: Placebo 12 weeks, 40mg adalimumab remaining 12 weeks arm 2: 40 mg every other week arm 3: 80 mg monthly

Interventions: intervention 1: adalimumab intervention 2: Placebo intervention 3: adalimumab
Intervention descriptions: intervention 1: Pre-filled syringe. See arm for more detail intervention 2: Pre-filled syringe. See arm for more detail intervention 3: Pre-filled syringe. See arm for more detail

Protocol document: