Upadacitinib Treatment for Relapsing Polychondritis in Adults Evaluating Safety and Effectiveness Compared to Standard Therapy

What this Trial Is About

Relapsing polychondritis RP is a rare autoimmune disease causing inflammation of cartilage in the body. Researchers are evaluating the drug Upadacitinib in adults with RP to see if it reduces disease activity and to assess its safety. The study compares Upadacitinib to standard treatments using corticosteroids combined with immunosuppressants to determine how well it controls RP symptoms. Participants will be randomly assigned to receive either Upadacitinib at a dose of 15 mg once daily or conventional corticosteroids plus immunosuppressants tailored to their condition, both for 24 weeks. Monthly hospital visits will be scheduled for checkups and tests to monitor treatment effects and safety. This trial includes a 24-week treatment period where researchers will also study immunological changes related to Upadacitinib. During the study, participants will attend monthly visits for clinical assessments, blood tests, and questionnaires about symptoms and quality of life. Researchers will measure changes in inflammation markers like CRP, disease activity scores, lymphocyte subpopulations, cytokines, and other inflammatory biomarkers. Safety will be monitored by recording any adverse events over the 24-week period. The total participation time corresponds to the 24-week treatment and monitoring period.

Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis