A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)

Phase 3 Completed 39 enrolled Medical University of Vienna

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind, controlled fashion, focussing on glucocorticoid-free remission of disease.

Timeline

Start: 2017-11-24
Primary completion: 2020-06-02
Completion: 2020-06-02

Outcome

Met primary endpoint

paper 12 out of 19 patients on tocilizumab (63.2%) and 2 out of 17 patients receiving placebo (11.8%, p=0.002) PMID 35210264 ↗

Publications

Bonelli M, Radner H, Kerschbaumer A, Mrak D, Durechova M, Stieger J, Husic R, Mandl P, Smolen JS, Dejaco C, Aletaha D. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial. Ann Rheum Dis. 2022 Jun;81(6):838-844. doi: 10.1136/annrheumdis-2021-221126. Epub 2022 Feb 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tocilizumab	Monoclonal antibody	162 mg	Subcutaneous
Background	Prednisone	Other / unclassified	20 mg	Oral