Dinesh Khanna | University of Michigan | Ann Arbor, MI
David Fox | University of Michigan | Ann Arbor, MI
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology | Ann Arbor, MI
UCLA Medical Center: Division of Rheumatology | Los Angeles, CA
University of Texas Houston Medicine School: Division of Rheumatology & Clinical | Houston, TX
Georgetown University Medical Center: Division of Rheumatology | Washington, DC
University of Pittsburgh Medical Center: Division of Rheumatology & Clinical Immunology | Pittsburg, PA
Hospital for Special Surgery, New York: Division of Rheumatology | New York, NY
Duke University Medical Center: Division of Rheumatology & Immunology | Durham, NC
Medical University of South Carolina: Division of Rheumatology & Immunology | Charleston, SC
Boston University School of Medicine: Rheumatology Section, Scleroderma Clinical Centers | Boston, MA
ITN075AI
Analysis
The main goal of the BRAVOS study is to determine the safety of an investigational study drug, brentuximab vedotin (ADCETRIS®), in diffuse cutaneous systemic sclerosis (dcSSc). Researchers will also assess whether ADCETRIS® has any effect on symptoms associated with dcSSc, and will examine the effect of the ADCETRIS® on the immune system by looking at blood and skin samples.
BRAVOS is a placebo-controlled trial, double-blinded study. Three quarters of participants will receive one of three dosages of brentuximab vedotin (ADCETRIS®) and one quarter will receive placebo.
A total of eight doses of brentuximab vedotin (ADCETRIS®) or placebo will be given by intravenous infusion once every 3 weeks over a 21 week period. Then there will be 4 follow-up visits over the next 6 months. Total study time is 1 year.
Brentuximab vedotin (ADCETRIS®) is approved by the FDA for the treatment of Hodgkin’s and other lymphomas. Researchers think brentuximab vedotin (ADCETRIS®) might also work in dcSSc by attaching to the immune cells that cause dcSSc. Since it has never been tested in patients with dcSSC, brentuximab vedotin (ADCETRIS®) it is considered an experimental drug for this disease.
Brentuximab vedotin (ADCETRIS®) attaches to the CD30 protein on cells and releases a toxin into the cell, causing the cell to die. CD30 is a protein found at low levels on the surface of normal healthy white blood cells. However, the CD30 protein is increased on certain types of cancer cells, and also may be increased on the overactive immune cells involved with inflammation and fibrosis in dcSSc.
You may be eligible to participate in the BRAVOS Study if you:
