ASSET (Abatacept Systemic SclErosis Trial) is an international, placebo-controlled, double blind, randomized trial of early diffuse cutaneous systemic sclerosis (SSc). This trial assesses abatacept (Orencia®, a recombinant fusion protein consisting of the extracellular domain of human CTLA4 is FDA approved biologic medication for rheumatoid arthritis and juvenile arthritis) in patients with early diffuse SSc with less than or equal to 36 months. The primary outcomes are to assess improvement in skin thickness and safety. The trial is a 12 month double blind study and is followed by a 6 month open label extension. Secondary and exploratory outcomes will include changes in the patient-reported outcomes, pulmonary function tests, joint swelling and tenderness, and other laboratory measures.
This is an investigator-initiated study coordinated by the University of Michigan with support from the National Institutes of Health and Bristol-Meyer-Squibb. The lead investigator is Dr. Dinesh Khanna, Director of the University of Michigan Scleroderma Program and the Data Coordinating Center is led by Dr. Catherine Spino.
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