Trials / Active Not Recruiting
Active Not RecruitingNCT05533164
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- 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, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | 1000mg rituximab in 250ml NaCl 0.9% intravenously |
| DRUG | Placebo | Placebo in 250ml NaCl 0.9% intravenously |
Timeline
- Start date
- 2023-02-09
- Primary completion
- 2027-01-01
- Completion
- 2028-01-01
- First posted
- 2022-09-08
- Last updated
- 2026-02-04
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05533164. Inclusion in this directory is not an endorsement.