Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sint Maartenskliniek
• Collaborators: Dutch Arthritis Association; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Polymyalgia rheumatica diagnosis fullfilling the 2012 EULAR/ACR classification criteria

• Experiencing a PMR relapse, defined as recurring of symptoms and increase in ESR/CRP while treated with prednisolone ≤ 5mg/day

• Informed consent

Exclusion Criteria:

• treatment with systemic immunosuppressants (other than glucocorticoids) 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.