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

NCT05533125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-02-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dutch Arthritis Association

    collaborator INDUSTRY

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Sint Maartenskliniek

    lead OTHER

Principal Investigators

  • Aatke van der Maas, MD PhD · Sint Maartenskliniek

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-10-29
Completion
2025-10-29

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05533125 on ClinicalTrials.gov