Rituximab's effect on reducing glucocorticoid use in patients with Polymyalgia Rheumatica
Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
This study is testing if the drug Rituximab can help people with Polymyalgia Rheumatica reduce their use of glucocorticoids and possibly achieve remission without them.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Sint Maartenskliniek Academic / other |
| Drugs / interventions | Rituximab |
| Locations | 1 site (Ubbergen, Gelderland) |
| Trial ID | NCT05533164 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Rituximab in reducing the need for glucocorticoids in patients with relapsing Polymyalgia Rheumatica (PMR). The study aims to confirm previous findings that suggested Rituximab could lead to glucocorticoid-free remission in PMR patients. Participants will be randomly assigned to receive either Rituximab or a placebo, with a focus on monitoring their symptoms and inflammatory markers over an extended period. The trial seeks to provide a larger sample size and longer follow-up than previous studies to validate the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include elderly patients diagnosed with Polymyalgia Rheumatica who are experiencing a relapse and cannot taper their glucocorticoid dosage below 5mg/day.
Not a fit: Patients with other rheumatic inflammatory diseases or those who have had recent treatment with certain immunosuppressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce glucocorticoid exposure and its associated side effects for PMR patients.
How similar studies have performed: Previous studies have shown promising results with Rituximab in similar contexts, but this trial aims to provide more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Polymyalgia rheumatica (PMR) diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria * Experiencing a PMR relapse, defined as recurring of symptoms and increase in erythrocyte sedimentation rate (ESR)/ C reactive protein (CRP) * Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent * Informed consent Exclusion Criteria: * Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide and azathioprine) 3 months prior to inclusion; * (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases; * concomitant conditions that might significantly interfere with PMR pain or movement evaluation as judged by the investigator; * previous hypersensitivity for RTX or contra-indications to RTX.
Where this trial is running
Ubbergen, Gelderland
- Sint Maartensklineik — Ubbergen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Aatke van der Maas — Sint Maartenskliniek
- Study coordinator: Pauline Bovens
- Email: p.bovens@maartenskliniek.nl
- Phone: 0031243272575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.