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

Phase

Condition

Polymyalgia Rheumatica (Pmr)

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

Rituximab

Placebo

Clinical Study ID

NCT05533125

REDUCE PMR 1

Ages > 50
All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Polymyalgia rheumatica diagnosis fulfilling the 2012 European League AgainstRheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria
Diagnoses less than 12 weeks ago
Glucocorticoid treatment less than 8 weeks and with dose equivalent of prednisolone ≤ 30 mg/day
Informed consent

Exclusion

Exclusion Criteria:

treatment with systemic immunosuppressants (other than glucocorticoids) 3 monthsprior to inclusion;
(clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatorydiseases;
concomitant conditions that might significantly interfere with PMR pain or movementevaluation as judged by the investigator;
previous hypersensitivity for RTX or contra-indications to RTX.

Study Design