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Brief Title: Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)
Study ID: NCT04040322
Brief Summary: This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Arthritis & Rheumatology Research, PLLC, Phoenix, Arizona, United States
Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States
University of Arizona - Arthritis Research Center, Tucson, Arizona, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California, Los Angeles Medical Center, Los Angeles, California, United States
Stanford University Medical Center, Palo Alto, California, United States
University of California San Francisco, San Francisco, California, United States
Georgetown University Medical Center - Department of Rheumatology, Washington, District of Columbia, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
West Michigan Rheumatology PLLC, Grand Rapids, Michigan, United States
University of Minnesota Maple Grove, Minneapolis, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Hospital for Special Surgery, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Cincinnati - Scleroderma Center, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
The University of Toledo Medical Center (UTMC) - Ruppert Health Center, Toledo, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC), Charleston, South Carolina, United States
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Wade Benton, Pharm D
Affiliation: Eicos Sciences, Inc.
Role: STUDY_DIRECTOR