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

Phase 3

Recruiting

• Conditions: Polymyalgia Rheumatica
• Interventions: Drug: Placebo; Drug: Rituximab

• Registration Number: NCT05533125
• Lead Sponsor: Sint Maartenskliniek

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-08
• Study Start: 2023-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0mg rituximab (placebo) intravenously once
Rituximab	Rituximab	1000mg rituximab intravenously once

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sint Maartensklineik; 🇳🇱 Ubbergen, Gelderland, Netherlands