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

Study acronym: REDUCE-PMR-2
StatusActive, Not Recruiting
PhasePhase 3
Started2023-02-09
View on ClinicalTrials.gov ↗

Amendment history

2026-02-02
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations, IPDSharing v6
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2025-05-13
Study Status, Oversight, IPDSharing v5
Primary completion date2026-01→2027-01
Completion date2027-01→2028-01
2023-05-22
Study Status, Arms and Interventions v4
InterventionsRituximab (Drug)→Placebo (Drug), Rituximab (Drug)
2023-05-17
Study Status, Arms and Interventions, Outcome Measures, Eligibility v3
Eligibility criteria+58 characters
[...] ythrocyte sedimentation rate (ESR)/ C reactive protein (CRP) Unable whileto treatedreduce withglucocorticoid prednisolonedose ≤below 5mg/day prednisolone or equivalent Informed consent Exclusion Criteria: treatmentTreatment with systemic immunosuppressants (other than glucocorticoidsGC, MTX, leflunomide and azathioprine) 3 months prior to inclusion; (clinical) suspect concomitan [...]
Secondary endpoints+289 characters
Percentage of patients in glucocorticoid-free remission Percentage of patients with glucocorticoid dose of ≤5mg/day Number of relapses Time to glucocorticoid-free remission Time to relapse Cumulative glucocorticoid dose Percentage of patients needing RTX/Placebo retreatment Adverse events
2023-03-14
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-01→confirmed 2023-02-09
Study sites0→1
Primary endpoints1 entry, revised
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
2022-09-29
Study Status, Eligibility v1
Eligibility criteria+132 characters
Inclusion Criteria: Polymyalgia rheumatica (PMR) diagnosis fullfillingfulfilling 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) while treated with prednisolone ≤ 5mg/day Informed consent [...]
2022-09-06
Original filing
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.
Trial Details
NCT Number NCT05533164
Lead Sponsor Sint Maartenskliniek
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Arthritis Association
Conditions Polymyalgia Rheumatica
Enrollment 174 participants
Start Date 2023-02-09
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-04