Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study Save

Date Added
October 17th, 2017
PRO Number
Pro00070403
Researcher
Richard Silver

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Keywords
Autoimmune disease, Drug Studies, Scleroderma, Skin
Summary

This study is being conducted in order to test the safety of Brentuximab Vedotin in subjects with Diffuse Cutaneous Systemic Sclerosis. The study involves a Screening visit, a Baseline visit and 12 study visits occurring every 3 to 4 weeks, with enrollment lasting approximately 52 weeks, during which enrolled subjects will receive either the study compound or placebo.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF IFETROBAN IN PATIENTS WITH DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS OR SYSTEMIC SCLEROSIS-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION Save

Date Added
October 11th, 2016
PRO Number
Pro00059217
Researcher
Richard Silver

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Keywords
Drug Studies, Pulmonary Arterial Hypertension (PAH), Scleroderma
Summary

A 52 week trial to evaluate the safety and effectiveness of the study drug ifetroban versus placebo, in treating patients with diffuse cutaneous systemic sclerosis or systemic sclerosis associated Pulmonary Arterial Hypertension. Subjects over age 18, with disease duration 60 months or less, along with other inclusion criteria will receive study drug or placebo for one year, along with safety testing.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

Comparison of Ultrasound Lung Comets and Serum Biomarkers in Systemic Sclerosis (SSc, Scleroderma): A longitudinal study. Save

Date Added
May 18th, 2016
PRO Number
Pro00053858
Researcher
Richard Silver

Silhouette
Keywords
Scleroderma
Summary

People with scleroderma often develop lung disease called interstitial lung disease. This study will use ultrasound to detect shadows on the lungs called "lung comets" among patients with scleroderma who have diagnosed lung disease, and those who have no evidence of lung disease. This is not a drug study. We are enrolling scleroderma patients to complete two visits over a period of approximately 12 months. Information about your medical history, exam findings, and laboratory tests will be collected for analysis. This study will involve approximately 40 participants.

Institution
MUSC
Recruitment Contact
Rupak Thapa
843-792-2300
thapa@musc.edu

Safety and Suitability of Dabigatran to Inhibit Thrombin in Scleroderma Save

Date Added
May 19th, 2015
PRO Number
Pro00042421
Researcher
Richard Silver

Silhouette
Keywords
Autoimmune disease, Lung, Scleroderma, Skin
Summary

This is a six month study to test the safety and suitability of dabigatran etexilate for the treatment of scleroderma-related interstitial lung disease.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

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