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Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse | Clinical Trials | Clareo Health

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

NCT05533164•Sint Maartenskliniek

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Polymyalgia rheumatica (PMR) diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria
•Experiencing a PMR relapse, defined as recurring of symptoms and increase in erythrocyte sedimentation rate (ESR)/ C reactive protein (CRP)
•Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent
•Informed consent

Exclusion Criteria

•Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide and azathioprine) 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.

Locations (1)

Sint Maartensklineik

Ubbergen, Gelderland, Netherlands

Key Dates

Start Date

February 9, 2023

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2028

Last Updated

February 4, 2026

Enrollment

174

ESTIMATED participants

Conditions

Polymyalgia Rheumatica

Interventions

Rituximab

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Rheumatology Patient Registry and Biorepository

A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)

Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica

Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic

Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)