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Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
Sponsor: Sint Maartenskliniek
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.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2023-02-09
Completion Date
2028-01
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Rituximab
1000mg rituximab in 250ml NaCl 0.9% intravenously
Placebo
Placebo in 250ml NaCl 0.9% intravenously
Locations (1)
Sint Maartensklineik
Ubbergen, Gelderland, Netherlands