This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptomatic Raynaud's Phenomenon secondary to Systemic Sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
Pacific Arthritis Care Center of Los Angeles
Los Angeles, California, United States
Change in Frequency of Symptomatic RP Attacks
The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline. The baseline weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during the 10- to 25-day baseline ePRO diary completion period. The double-blind endpoint weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during Days 8 to 21, inclusive.
Time frame: Day 8 - Day 21 will be compared to baseline
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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 D.C., District of Columbia, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, 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
...and 6 more locations