Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Polymyalgia Rheumatica Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Status Terminated

Clinical Trial Summary

Primary Objective:

To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen.

Secondary Objectives:

• To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to:

• Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time.

• Cumulative CS (including prednisone) exposure.

• To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR.

• To measure sarilumab serum concentrations in participants with PMR.

• To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

Clinical Trial Description

Study duration per participant was approximative 62 weeks including up to a 4-week screening period, 52-week treatment period and 6-week follow-up period. ;

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

• NCT number: NCT03600818
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 3
• Start date: October 9, 2018
• Completion date: May 19, 2021