Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (RITUXERA).

ABSTRACT:

Background

The optimal retreatment strategy with rituximab for rheumatoid arthritis (RA) remains a point of discussion. Depending on local guidelines, rituximab can either be administered at fixed intervals or when losing disease control, balancing therapeutic effectiveness with drug overexposure. However, treatment based on loss of disease control may significantly affect patients' lives, provoking uncertainty and potentially leading to progressive joint damage. Moreover, as low-dose rituximab proved to be effective in treating RA while decreasing toxicity, drug exposure may be limited by tapering down rituximab doses guided by disease activity.

Methods

RITUXERA is a 104-week open-label multicentre randomised controlled superiority trial. In total, 134 patients with RA trea

SUBMITTER: De Meyst E 

PROVIDER: S-EPMC11476693 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature