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

Study Overview
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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.

Official Title
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Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica

Conditions
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Polymyalgia Rheumatica

Intervention / Treatment
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* Drug: Rituximab
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab<br>1000mg rituximab intravenously once | Drug: Rituximab<br>* Rituximab 1000mg in 250ml NaCl 0.9% intravenously with usual premedication<br>* Other names: Truxima;|
| Placebo Comparator: Placebo<br>0mg rituximab (placebo) intravenously once | Drug: Placebo<br>* Placebo in 250ml NaCl 0.9% intravenously with usual premedication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At week 52 | 

Secondary Outcome Measures

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