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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Polymyalgia Rheumatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rituximab

1000mg rituximab intravenously once

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

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

Placebo

0mg rituximab (placebo) intravenously once

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in 250ml NaCl 0.9% intravenously with usual premedication

Interventions

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Rituximab

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

Intervention Type DRUG

Placebo

Placebo in 250ml NaCl 0.9% intravenously with usual premedication

Intervention Type DRUG

Other Intervention Names

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Rixathon MabThera Ruxience Truxima

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No