Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Giant Cell Arteritis Clinical Trial

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

Status Terminated

Clinical Trial Summary

Primary Objective:

To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:

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

• Clinical responses (such as responses based on 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 GCA.

• To measure sarilumab serum concentrations in participants with GCA.

• To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

Clinical Trial Description

Study duration per participant was approximately 82 weeks, including an up to 6-week screening period, 52-week treatment period, and 24-week follow-up period. ;

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

• NCT number: NCT03600805
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 3
• Start date: November 20, 2018
• Completion date: November 24, 2020