Open-Label Two-Stage Study Comparing Immunomodulatory Treatments for Adults With Relapsing Polychondritis

What this Trial Is About

This research aims to compare the effectiveness of five standard treatment options for patients with relapsing polychondritis RP, a condition characterized by inflammation of cartilage and other tissues. The study is a two-stage, open-label, non-randomized pilot trial involving twenty patients with mild to moderately active RP. It evaluates immunomodulatory medications in a pragmatic clinical setting to better understand their impact on managing RP symptoms. Participants will start in Stage 1 if they have not previously used methotrexate MTX or azathioprine AZA, or have active disease on these drugs for 8 weeks or less. Those new to treatment will begin MTX or AZA depending on suitability. Patients who do not meet the primary effectiveness endpoint or experience relapse or intolerance will move to Stage 2, where they will receive either a tumor necrosis factor inhibitor adalimumab or infliximab or an interleukin 6 inhibitor tocilizumab. All patients receive glucocorticoids tapered to 5 mg daily by week 21 following a standardized schedule. During the 26-week study, participants will undergo assessments including physician and patient global response evaluations at weeks 0, 12, and 26, quality of life measurements, and monitoring of time to disease flare and safety of study drugs. The primary outcome is efficacy of the treatments over 26 weeks. Patients will have regular follow-up visits to monitor disease activity, medication effects, and adherence to therapy. The study provides detailed tracking to understand how these therapies work in controlling RP symptoms.

An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis