drugset / Trial / NCT05533164

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

NCT05533164 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration, small sample size and only few relapsing patients included in this study require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in relapsing PMR patients during glucocorticoid taper.

Timeline

Start
2023-02-09
Primary completion
2027-01
Completion
2028-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 1000 mg Intravenous