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Open Study: Evaluation of Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis

Brief Summary:

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).

Click here to learn more about the study.
ClinicalTrials.gov Identifier: NCT03600805