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.
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.