Open Study: Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Brief Summary: March 20, 2020 Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary…...
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…...
Early VF-Funded Study Paves Way for New ANCA Vasculitis Clinical Trial
More than a decade ago, Donna O’Dell Bunch, PhD, was co-investigator in a Vasculitis Foundation-funded trial that studied changes in B cells (white blood cells that form antibodies) in patients with ANCA-associated vasculitis, and the medical implications of those changes on the disease. The findings from that 2007 clinical trial,…...
FDA Approves Otezla®for the Treatment of Oral Ulcers in Behcet’s Disease
Celgene Corporation announced on July 19 that the U.S. Food and Drug Administration (FDA) has approved Otezla® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behcet’s disease. Otezla, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only…...
