drugset / Trial / NCT05533164
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
Phase 3
Active not recruiting
174 enrolled
Sint Maartenskliniek
Dutch Arthritis Association · collabZonMw: The Netherlands Organisation for Health Research and Development · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |