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

Last updated: May 22, 2023
Sponsor: Sint Maartenskliniek
Overall Status: Active - Recruiting

Phase

3

Condition

Polymyalgia Rheumatica (Pmr)

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

Placebo

Rituximab

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 months priorto 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

Total Participants: 114
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 01, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Sint Maartensklineik

    Ubbergen, Gelderland 6574 NA
    Netherlands

    Active - Recruiting

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