Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

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).

Timeline

Start

2018-11-20

Primary completion

2020-11-24

Completion

2020-11-24

Publications

• Schmidt WA, Dasgupta B, Sloane J, Giannelou A, Xu Y, Unizony SH, Mackie SL, Gonzalez-Gay MA, Spiera R, Warrington KJ, Villiger PM, Nivens MC, Akinlade B, Lin Y, Buttgereit F, Stone JH. A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis. Arthritis Res Ther. 2023 Oct 16;25(1):199. doi: 10.1186/s13075-023-03177-6.

Drugs

Indications