Clinical Trial

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

Study acronym: REDUCE-PMR-2
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-09-06; most recent amendment 2026-02-02.
Status change: Recruiting → Active, Not Recruiting 2026-02-02
Status change: Not Yet Recruiting → Recruiting 2023-03-14
Trial Details
NCT Number NCT05533164
Lead Sponsor Sint Maartenskliniek
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Arthritis Association
Conditions Polymyalgia Rheumatica
Enrollment 174 participants
Start Date 2023-02-09
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-04