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…...
VF Celebrates Vasculitis Awareness Month 2018
The Vasculitis Foundation, the world’s largest organization dedicated to providing advocacy, education and support for people with vasculitis, announces the launch of Vasculitis Awareness Month (May 2018), an annual effort to create global awareness of the disease that’s so rare that fewer than 200,000 new cases are diagnosed each year.…...
