Last updated on December 2019

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA


Brief description of study

Primary Objective:

To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients 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 patients 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 patients with GCA.
  • To measure sarilumab serum concentrations in patients with GCA.
  • To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

Detailed Study Description

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

Clinical Study Identifier: NCT03600805

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