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

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2028-01-31

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, 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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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

1000mg rituximab in 250ml NaCl 0.9% intravenously

Placebo

0mg rituximab (placebo) intravenously once

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in 250ml NaCl 0.9% intravenously

Interventions

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Rituximab

1000mg rituximab in 250ml NaCl 0.9% intravenously

Intervention Type DRUG

Placebo

Placebo in 250ml NaCl 0.9% intravenously

Intervention Type DRUG

Other Intervention Names

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Rixathon MabThera Ruxience Truxima

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No