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NCT Number: NCT05533164

Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica Patients Experiencing a PMR Relapse

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, small sample size and only few relapsing patients included in this study require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in relapsing PMR patients during glucocorticoid taper.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Polymyalgia Rheumatica Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sint Maartensklineik

Ubbergen, Gelderland, 6574 NA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

1000mg rituximab in 250ml NaCl 0.9% intravenously

Other names: Rixathon, MabThera, Ruxience, Truxima

Placebo

Drug

Placebo in 250ml NaCl 0.9% intravenously

Primary outcomes

  1. Between group difference in percentage of patients in glucocorticoid-free remission

    Time frame: At week 52

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

Secondary outcomes

  1. Percentage of patients in glucocorticoid-free remission

    Time frame: 21 weeks

    Percentage of patients in glucocorticoid-free remission

  2. Percentage of patients with glucocorticoid dose of ≤5mg/day

    Time frame: 52 weeks

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

  3. Number of relapses

    Time frame: 52 weeks

    Number of relapses

  4. Time to glucocorticoid-free remission

    Time frame: 52 weeks

    Time to glucocorticoid-free remission in days during the study period

  5. Time to relapse

    Time frame: 52 weeks

    Time to relapse in days during the study period

  6. Cumulative glucocorticoid dose

    Time frame: 52 weeks

    Cumulative glucocorticoid dose

  7. Percentage of patients needing RTX/Placebo retreatment

    Time frame: 52 weeks

    Percentage of patients needing RTX/Placebo retreatment

  8. Adverse events

    Time frame: 52 weeks

    Adverse events

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Collaborators

  • Dutch Arthritis Association
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: REDUCE-PMR-2

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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