Suspended

REDUCE-PMR-2Rituximab's Role in Reducing Glucocorticoid Use in Relapsing PMR Patients

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Study Aim

This study aims to evaluate if Rituximab can reduce the need for glucocorticoid use in patients with relapsing Polymyalgia Rheumatica (PMR), by comparing the percentage of patients in glucocorticoid-free remission at week 52.

What is being tested

Rituximab

+ Placebo

Drug
Who is being recruted

Connective Tissue Diseases+3

+ Muscular Diseases

+ Musculoskeletal Diseases

Over 50 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: February 2023
See protocol details

Summary

Principal SponsorSint Maartenskliniek
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 9, 2023

Actual date on which the first participant was enrolled.

Polymyalgia rheumatica (PMR) is a common condition among the elderly that can significantly reduce quality of life if left untreated. The main treatment for PMR is glucocorticoids, but these have side effects, making it important to find treatments that can reduce the need for them. A previous study showed that a drug called Rituximab (RTX) helped more patients achieve a glucocorticoid-free remission compared to a placebo. However, this study was small and short, so more research is needed to confirm these results. This larger, randomized controlled trial aims to investigate the effectiveness of RTX in helping PMR patients who are experiencing a relapse to achieve a glucocorticoid-free remission during the tapering of glucocorticoid treatment. During this study, participants will be randomly assigned to receive either RTX or a placebo. The main goal is to measure the difference between the two groups in the percentage of patients who achieve a glucocorticoid-free remission at week 52. This remission is defined by a PMR activity score of less than 10. The study will monitor the participants' progress and evaluate the potential benefits and risks of RTX treatment.

Official TitleRituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse
NCT05533164
Principal SponsorSint Maartenskliniek
Last updated: February 5, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

174 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Connective Tissue DiseasesMuscular DiseasesMusculoskeletal DiseasesPolymyalgia RheumaticaRheumatic DiseasesSkin and Connective Tissue Diseases

Criteria

4 inclusion criteria required to participate
Unable to reduce glucocorticoid dose below 5mg/day prednisolone or equivalent
Informed consent
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)
4 exclusion criteria prevent from participating
Treatment with systemic immunosuppressants (other than GC, MTX, leflunomide and azathioprine) 3 months prior to inclusion
Previous hypersensitivity for RTX or contra-indications to RTX
(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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
1000mg rituximab intravenously once

Group II

Placebo
0mg rituximab (placebo) intravenously once

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sint Maartensklineik

Ubbergen, NetherlandsOpen Sint Maartensklineik in Google Maps
SuspendedOne Study Center