Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Status:
Terminated
Trial end date:
2020-11-24
Target enrollment:
Participant gender:
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).