Testing a Two-Step Treatment Approach for Rheumatoid Arthritis with TNF Inhibitors Followed by Abatacept

What this Trial Is About

Researchers are studying rheumatoid arthritis RA, focusing on patients who have not responded well to initial treatments like methotrexate or leflunomide. The trial compares two treatment strategies for patients positive for specific auto-antibodies ACPA who initially receive TNF inhibitors. The goal is to see if starting with TNF inhibitors followed by abatacept, a cell-targeted biologic drug, improves remission rates compared to continuing TNF inhibitors alone. This phase 3 randomized controlled trial aims to optimize treatment and tolerance in RA patients. All participants begin with 12 weeks of subcutaneous TNF inhibitor treatment. After this, those showing a moderate response are randomly assigned to one of two groups one switches to abatacept for 36 weeks, while the other continues TNF inhibitors for the same period. If patients in the TNF inhibitor group do not respond sufficiently at 24 or 36 weeks, a second TNF inhibitor may be offered. Concomitant use of methotrexate or leflunomide and low-dose steroids is permitted under stable conditions. Participants will attend regular visits for clinical evaluations using various disease activity scores and tolerance assessments throughout the 48-week study period. Researchers will measure remission rates, changes in auto-antibody levels, flare frequency, steroid use, serious adverse events, and quality of life indices. The primary outcome is the percentage of patients achieving remission 36 weeks after randomization, with additional secondary outcomes assessed at multiple time points.

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis