Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Anti-Inflammatory Biological Therapy adalimumab Disease-Modifying Antirheumatic Drugs Antirheumatic Agents Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief summary:
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.

Detailed description:

Arms:
arm 1: Participants in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration. arm 2: Participants in the Standard of Care arm will receive methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may be initiated after a minimum of 6 months.

Interventions: intervention 1: adalimumab intervention 2: Methotrexate
Intervention descriptions: intervention 1: Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor. intervention 2: Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.

Protocol document: