NCT05533125

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Recently Diagnosed

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Sint Maartenskliniek · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 and small sample size require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in newly diagnosed PMR patients during glucocorticoid taper.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 1000mg in 250ml NaCl 0.9% intravenously with usual premedication
DRUG	Placebo	Placebo in 250ml NaCl 0.9% intravenously with usual premedication

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-10-29
• Completion: 2025-10-29
• First posted: 2022-09-08
• Last updated: 2026-02-03

Locations

1 site across 1 country: Netherlands