Individualized Adalimumab Tapering Strategy for Rheumatoid Arthritis Patients in Remission Based on Drug Levels

What this Trial Is About

Rheumatoid arthritis RA is a common inflammatory joint disease. Researchers are studying an individualized strategy to reduce the dose of adalimumab, a biological drug, in patients who have achieved remission. The study aims to find the best adalimumab blood concentration to maintain before tapering treatment, as current guidelines for stepping down medication are unclear and flares may occur during tapering. Participants receive adalimumab injections combined with methotrexate and will be randomly assigned to one of three groups a single-arm group following a clinical tapering strategy based on disease activity every three months, a maintenance group continuing the same adalimumab regimen, or an optimized tapering group where the timing of dose spacing depends on adalimumab trough blood levels. The tapering process and group assignment are randomized over 12 months. During the study, participants will be assessed every three months using disease activity scores to monitor flares. Researchers will track flare-ups over 15 months as the primary outcome, with infections as a secondary outcome. Participants medication doses and health status will be regularly evaluated to guide tapering and ensure safety throughout the study period.

Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study