Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse (REDUCE-PMR-2)

February 2, 2026 updated by: Sint Maartenskliniek
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Ubbergen, Gelderland, Netherlands, 6574 NA
        • Sint Maartensklineik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab
1000mg rituximab intravenously once
Drug: Rituximab
1000mg rituximab in 250ml NaCl 0.9% intravenously
Other Names:
  • MabThera
  • Ruxience
  • Truxima
  • Rixathon
Placebo Comparator: Placebo
0mg rituximab (placebo) intravenously once
Drug: Placebo
Placebo in 250ml NaCl 0.9% intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between group difference in percentage of patients in glucocorticoid-free remission
Time Frame: At week 52
Between group difference in percentage of patients in glucocorticoid-free remission (PMR activity score < 10) at week 52
At week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients in glucocorticoid-free remission
Time Frame: 21 weeks
Percentage of patients in glucocorticoid-free remission
21 weeks
Percentage of patients with glucocorticoid dose of ≤5mg/day
Time Frame: 52 weeks
Percentage of patients with glucocorticoid dose of ≤5mg/day
52 weeks
Number of relapses
Time Frame: 52 weeks
Number of relapses
52 weeks
Cumulative glucocorticoid dose
Time Frame: 52 weeks
Cumulative glucocorticoid dose
52 weeks
Percentage of patients needing RTX/Placebo retreatment
Time Frame: 52 weeks
Percentage of patients needing RTX/Placebo retreatment
52 weeks
Adverse events
Time Frame: 52 weeks
Adverse events
52 weeks
Time to glucocorticoid-free remission
Time Frame: 52 weeks
Time to glucocorticoid-free remission in days during the study period
52 weeks
Time to relapse
Time Frame: 52 weeks
Time to relapse in days during the study period
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sint Maartenskliniek

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Arthritis Association

Investigators

  • Principal Investigator: Aatke van der Maas, Sint Maartenskliniek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDUCE-PMR-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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