NCT05533125

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2025

Completed
Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

September 6, 2022

Last Update Submit

February 2, 2026

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Percentage of patients in glucocorticoid-free remission

    21 weeks

  • Percentage of patients with glucocorticoid dose of ≤5mg/day

    52 weeks

  • Number of relapses

    52 weeks

  • Time to glucocorticoid-free remission

    52 weeks

  • Time to relapse

    52 weeks

  • +3 more secondary outcomes

Study Arms (2)

Rituximab

EXPERIMENTAL

1000mg rituximab intravenously once

Drug: Rituximab

Placebo

PLACEBO COMPARATOR

0mg rituximab (placebo) intravenously once

Drug: Placebo

Interventions

RituximabDRUG

Rituximab 1000mg in 250ml NaCl 0.9% intravenously with usual premedication

Also known as: Rixathon, MabThera, Ruxience, Truxima
Rituximab
PlaceboDRUG

Placebo in 250ml NaCl 0.9% intravenously with usual premedication

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Maartensklineik

Ubbergen, Gelderland, 6574 NA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 39400109DERIVED

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Aatke van der Maas, MD PhD

    Sint Maartenskliniek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 8, 2022

Study Start

February 1, 2023

Primary Completion

October 29, 2025

Study Completion

October 29, 2025

Last Updated

February 3, 2026

Record last verified: 2026-02

Locations

NL(1)