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

• 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 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.

• 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

• Diagnoses less than 12 weeks ago

• Glucocorticoid treatment less than 8 weeks and with dose equivalent of prednisolone ≤ 25mg/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.