STUDY SUSPENDED DUE TO COVID-19 (April 2020)
Brief Summary:
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).
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ClinicalTrials.gov Identifier: NCT03600805
