Trial intelligence / Profile preview

Rituximab in newly diagnosed Polymyalgia Rheumatica

NCT05533125Phase 3

Key facts

Status: Completed
Start: Feb 2023
Primary completion: Oct 2025
Countries: 1
Sponsor: Sint Maartenskliniek
Modality: Monoclonal Antibodies

Drugs: rituximab
Conditions: polymyalgia rheumatica (PMR)

Overview

Phase 3, randomised, double-blind trial in polymyalgia rheumatica (PMR) comparing Rituximab with Placebo (2 arms). Primary endpoint: Glucocorticoid-free remission at 52 weeks. Started Feb 2023; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Rituximab
1000mg rituximab intravenously once
Placebo
0mg rituximab (placebo) intravenously once

Who it enrols

Newly diagnosed (<12 weeks) polymyalgia rheumatica patients on glucocorticoid treatment (<8 weeks, <=30mg/day prednisolone equivalent), without recent use of other systemic immunosuppressants or concomitant rheumatic inflammatory diseases.

Endpoints

Primary

Glucocorticoid-free remission52 weeks

Secondary

Glucocorticoid-free remission21 weeks
Glucocorticoid dose of <=5mg/day52 weeks
Number of relapses52 weeks
Time to glucocorticoid-free remission52 weeks
Time to relapse52 weeks
Cumulative glucocorticoid dose52 weeks
Percentage of patients needing RTX/Placebo retreatment52 weeks
Adverse events52 weeks

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