Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Recently Diagnosed (REDUCE-PMR-1)

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica

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.

Study Overview

• Status: Completed
• Conditions: Polymyalgia Rheumatica
• Intervention / Treatment: Drug: Rituximab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Ubbergen, Gelderland, Netherlands, 6574 NA
      • Sint Maartensklineik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rituximab; 1000mg rituximab intravenously once	Drug: Rituximab; Rituximab 1000mg in 250ml NaCl 0.9% intravenously with usual premedication; Other Names: MabThera; Ruxience; Truxima; Rixathon
Placebo Comparator: Placebo; 0mg rituximab (placebo) intravenously once	Drug: Placebo; Placebo in 250ml NaCl 0.9% intravenously with usual premedication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At week 52

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sint Maartenskliniek
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Dutch Arthritis Association
• Investigators: Principal Investigator: Aatke van der Maas, MD PhD, Sint Maartenskliniek

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): October 29, 2025
• Study Completion (Actual): October 29, 2025

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Polymyalgia Rheumatica; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Rituximab
• Other Study ID Numbers: REDUCE PMR 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No