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Can a single drug free PMR patients from steroids?

NCT ID NCT05533164

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether rituximab, a drug that calms certain immune cells, can help people with polymyalgia rheumatica (PMR) stop taking steroids without their symptoms returning. The study includes 174 adults who are currently experiencing a PMR relapse and cannot lower their steroid dose below 5 mg per day. Participants receive either rituximab or a placebo, and researchers track how many achieve steroid-free remission after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab (a drug that targets certain immune cells)
What this could lead to
If it works, this could offer a steroid-free option for people with polymyalgia rheumatica, reducing long-term side effects from steroids.
What could go wrong
This is a phase 3 trial, but previous evidence was small and short. Rituximab can increase infection risk, and it may not help everyone achieve steroid-free remission.

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

About 174 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jan 2028

An estimate. End dates often move.

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 (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.

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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

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