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New hope for PMR patients: drug may reduce need for steroids

NCT ID NCT05533125

Disease control Sponsor: Sint Maartenskliniek Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether rituximab, a drug that calms the immune system, can help people with polymyalgia rheumatica (PMR) stop taking steroids sooner. PMR causes pain and stiffness, and steroids are the main treatment but have side effects. The trial included 114 newly diagnosed patients and compared rituximab to a placebo, with the goal of seeing if more patients could achieve remission without steroids after one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

114 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Polymyalgia rheumatica diagnosis fulfilling the 2012 European League Against Rheumatism (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 Criteria: * treatment with systemic immunosuppressants (other than glucocorticoids) 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.

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Conditions

The condition(s) this trial relates to.

polymyalgia rheumatica

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polymyalgia rheumatica

Contacts and locations

Locations

  • Sint Maartensklineik

    Ubbergen, Gelderland, 6574 NA, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.