A phase 2 study to evaluate subcutaneous abatacept vs placebo in diffuse cutaneous systemic sclerosis-a double-blind, placebo-controlled, randomized controlled trial Save

Date Added
September 8th, 2015
PRO Number
Pro00043904
Researcher
Faye Hant
Keywords
Scleroderma, Skin
Summary

This study, comprised of an initial 12 month double-blind treatment phase of abatacept 125mg injected once a week vs placebo, followed by six month open label treatment phase, is designed to evaluate safety and effectiveness of the study drug, in subjects with diffuse systemic sclerosis.

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

Prospective Registry of Early Systemic Sclerosis, (PRESS) Phenotypic, Serologic, and Biomarker/Genetic Characteristics of Early Diffuse Cutaneous Systemic Sclerosis Save

Date Added
September 18th, 2012
PRO Number
Pro00019768
Researcher
Faye Hant
Keywords
Autoimmune disease, Scleroderma
Summary

The PRESS study is a natural history study which will collect data and biological material. All patients who participate will need to contribute clinical data (Part 1). Additionally, three optional sample collection protocols will also be followed: Part 2: blood samples for protein, DNA and RNA studies; Part 3: Skin biopsy samples; Part 4: Other tissue biopsies (e.g. gastrointestinal biopsy) or bronchoalveolar lavage (BAL) from patients who have undergone the respective procedures as part of their routine clinical care.

Institution
MUSC
Recruitment Contact
Dana Rosson
843-792-2014
rosson@musc.edu

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