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.
Systemic Sclerosis is a devastating disease with unknown cause. No approved treatment is available. This is a double blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of oral nintedanib for 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease.
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.
The purpose of this study is to create and maintain a registry, which is a database (a searchable collection of information) about children, adolescents and young adults with pediatric onset of rheumatic diseases. This data may help in the evaluation of the safety and benefit of medications that are prescribed to patients who have rheumatic diseases.
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.
Systemic sclerosis (SSc) or scleroderma is an autoimmune disease in which a person?s own immune cells attack his/her skin and internal organs, including the joints, lungs, heart, intestinal tract, and kidneys. The effects on the lungs, including pulmonary arterial hypertension (PAH), are among the most serious complications of SSc. In general, PAH is defined as an increase in pressure in the pulmonary arteries (the main blood vessels that lead from the heart to the lungs). Treatments for PAH have focused on symptom management rather than curing the disease.
This study has been designed to look at a new approach to treating the cause of the disease, rather than the symptoms of the disease. Recent research suggests that SSc-PAH may be the result of an ?attack? by immune cells. This study will look at the effect of the drug rituximab on the immune system and the immune ?attack? on the lungs. Rituximab is an immunosuppressive drug that eliminates the B cells for a few months, and therefore may halt the B cell attack on the lungs thought to be associated with this disease.The recovery of your B cells will be closely monitored throughout the study by blood testing.
The purpose of this study is to examine fibrosis (excessive scar tissue formation) and inflammation in the lungs of patients with scleroderma and control subjects. Scleroderma is an autoimmune connective tissue disease characterized by skin, lung, and other organ fibrosis. The goal of this study is to gain more information about scleroderma to potentially aid in the development of potential new treatments. For this study we are recruiting the healthy control subjects (not having scleroderma and other autoimmune diseases, smocking no more then 1 pack cigarettes/day. The donors who will be participating in this trial will be asked to give a blood sample by blood draw and possibly skin sample through a skin punch.
Systemic lupus erythematosus (lupus; SLE) and Systemic Sclerosis (scleroderma; SSc) are relatively rare rheumatic diseases that disproportionately impact the African American community, and particularly African American women. The causes of lupus and scleroderma are unknown, but thought to include both genetic and environmental factors. We are enrolling lupus and scleroderma patients, and healthy control subjects. This is not a drug study. The purpose of this study is to better understand the factors that predispose people to develop lupus and scleroderma. Information about medical, social and family history, medications, physical exam findings, and laboratory tests will be collected for analysis. This study will involve approximately 910 volunteers.
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.