CompletedNCT05533125REDUCE-PMR-1Updated Feb 3, 2026

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Recently Diagnosed

A Phase 3 interventional study of Rituximab and Placebo in Polymyalgia Rheumatica, sponsored by Sint Maartenskliniek. Completed at 1 site in Netherlands. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Sint Maartenskliniek · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 114
Allocation: Randomized
Ages: 50 Years and older
Sex: All

Study 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 and small sample size require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in newly diagnosed PMR patients during glucocorticoid taper.

Conditions studied

Polymyalgia Rheumatica

Browse trials for

Polymyalgia Rheumatica 135

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 114 participants (actual)

Study arms

Experimental
Rituximab
1000mg rituximab intravenously once
Drug: Rituximab
Placebo comparator
Placebo
0mg rituximab (placebo) intravenously once
Drug: Placebo

Interventions

DrugRituximab
Rituximab 1000mg in 250ml NaCl 0.9% intravenously with usual premedication
Also known as: Rixathon, MabThera, Ruxience, Truxima
DrugPlacebo
Placebo in 250ml NaCl 0.9% intravenously with usual premedication

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Sint Maartensklineik
Ubbergen, Gelderland 6574 NA, Netherlands

References and documents

Publications

Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14. PubMed 39400109 ↗

Registry details

Key details

Study ID: NCT05533125
Lead sponsor: Sint Maartenskliniek
Collaborators: Dutch Arthritis Association, ZonMw: The Netherlands Organisation for Health Research and Development
Responsible party: Sponsor
First posted: Sep 8, 2022
Start date: Feb 1, 2023
Primary completion: Oct 29, 2025
Completion: Oct 29, 2025
Last update: Feb 3, 2026

Study contacts

Aatke van der Maas, MD PhD

principal investigator · Sint Maartenskliniek

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Polymyalgia Rheumatica→

Other studies from this sponsor

Sint Maartenskliniek

Start the discussion