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

Last updated: May 13, 2025
Sponsor: Sint Maartenskliniek
Overall Status: Active - Recruiting

Phase

3

Condition

Connective Tissue Diseases

Polymyalgia Rheumatica (Pmr)

Collagen Vascular Diseases

Treatment

Placebo

Rituximab

Clinical Study ID

NCT05533164
REDUCE-PMR-2
  • 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, 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Polymyalgia rheumatica (PMR) diagnosis fulfilling the 2012 European League AgainstRheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria

  • Experiencing a PMR relapse, defined as recurring of symptoms and increase inerythrocyte sedimentation rate (ESR)/ C reactive protein (CRP)

  • Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent

  • Informed consent

Exclusion

Exclusion Criteria:

  • Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide andazathioprine) 3 months prior 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

Total Participants: 174
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 09, 2023
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Sint Maartensklineik

    Ubbergen, Gelderland 6574 NA
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.