NCT05533125 (REDUCE-PMR-1) is a Phase 3 clinical trial of Rituximab in Polymyalgia Rheumatica, sponsored by Sint Maartenskliniek.

Who is sponsoring NCT05533125?

NCT05533125 is sponsored by Sint Maartenskliniek.

What drugs are being tested in NCT05533125?

Interventions in NCT05533125: Rituximab, Placebo.

What condition does NCT05533125 study?

NCT05533125 studies Polymyalgia Rheumatica.

Is NCT05533125 still recruiting?

NCT05533125 is currently completed. Last updated 3 February 2026.

Last reviewed 2026-02-03 · How we verify

NCT05533125: REDUCE-PMR-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 3 February 2026

What this trial tests

Phase 3 trial testing Rituximab in Polymyalgia Rheumatica in 114 participants. Completed in 29 October 2025.

Timeline

1 February 2023

Primary endpoint
29 October 2025

29 October 2025

Quick facts

Lead sponsor	Sint Maartenskliniek
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	114
Start date	1 February 2023
Primary completion	29 October 2025
Estimated completion	29 October 2025
Sites	1 location across Netherlands

Drugs / interventions tested

Rituximab — full drug profile →
Placebo

Conditions studied

Polymyalgia Rheumatica — all drugs for Polymyalgia Rheumatica →

Sponsor

Sint Maartenskliniek — full company profile →

Who can join

50 and older, any sex, with Polymyalgia Rheumatica. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Modern Management of Isolated Polymyalgia Rheumatica.
Harkins P, Cowley S, Burke E, Harrington R, et al · · 2025 · PMID 41085890 · DOI 10.1007/s40744-025-00797-z
Traditional and Emerging Strategies for Managing Polymyalgia Rheumatica: Insights into New Treatments.
García-Porrúa C, Heras-Recuero E, Blázquez-Sánchez T, Torres-Roselló A, et al · · 2024 · PMID 39518631 · DOI 10.3390/jcm13216492

Verify or expand the search:

Other trials of Rituximab

Trials testing the same drug.

NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia · Phase 1, PHASE2 · recruiting
NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting

Other recruiting trials for Polymyalgia Rheumatica

Currently open trials in the same condition.

NCT06647134 — A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoi · recruiting
NCT06331312 — Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) · Phase 3 · active not recruiting
NCT06172361 — Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica · Phase 3 · recruiting
NCT05935709 — DANIsh VASculitis Database (DANIVAS) · recruiting
NCT06460142 — Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic · recruiting

Other Sint Maartenskliniek trials

Trials by the same sponsor.

NCT07160231 — REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases · Phase 4 · recruiting
NCT06578182 — The Effect of ColcHicine on the Incidence of Knee or Hip Replacements · Phase 3 · recruiting
NCT06259227 — Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury · NA · terminated
NCT06214546 — Effect of Different Support Systems on Gait · NA · completed
NCT06516120 — Kinematics of Movements Provoked by an Augmented Reality App · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05533125 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sint Maartenskliniek
Last refreshed: 3 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05533125.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing