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).
› Valuation of efficacy and safety of Sarilumab in patients with GCA.
Detailed 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.
Inclusion criteria:
› Diagnosis of giant cell arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology classification criteria.
› New onset active disease or refractory active disease. › At least one of the symptoms of GCA within 6 weeks of baseline. › Either erythrocyte sedimentation rate ≥30 mm/hour or C-reactive protein ≥10 mg/L within 6 weeks of baseline.
› Receiving or able to receive prednisone 20-60 mg/ day for the treatment of active GCA.
Contact: 800.633.1610, Ext. 1
Email: [email protected]
Study Locations: Denver, Colorado Boca Raton, Florida Duncansville, Pennsylvania
To learn more about the study, including the exclusion criteria: https://clinicaltrials.gov/ct2/show/NCT03600805
