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
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

Boehringer Ingelheim Trial No. 1199.214: A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ?Systemic Sclerosis associated Interstitial Lung Disease?(SSc-ILD) Save

Date Added
August 19th, 2016
PRO Number
Pro00050358
Researcher
Ria Gripaldo
Keywords
Lung, Scleroderma
Summary

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.

Institution
Palmetto
Recruitment Contact
Alisha Henderson
803-545-5453
alisha.henderson@uscmed.sc.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
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

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry Save

Date Added
November 3rd, 2015
PRO Number
Pro00048606
Researcher
Natasha Ruth
Keywords
Arthritis, Autoimmune disease, Fibromyalgia, Lupus, Pediatrics, Rheumatoid, Sarcoidosis, Scleroderma
Summary

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.

Institution
MUSC
Recruitment Contact
Catherine Mims
843-792-5696
pedsrheum@musc.edu

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

Safety and Suitability of Dabigatran to Inhibit Thrombin in Scleroderma Save

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

A Randomized, Double-blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) Save

Date Added
February 17th, 2015
PRO Number
Pro00038310
Researcher
Rahul Argula
Keywords
Autoimmune disease, Drug Studies, Immune System, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH), Sarcoidosis, Scleroderma
Summary

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.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

Caveolin-1 regulates monocyte-fibrocyte lineage cell functions via CXCR4 Save

Date Added
December 17th, 2013
PRO Number
Pro00029115
Researcher
Elena Tourkina
Keywords
Autoimmune disease, Scleroderma
Summary

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.

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

The Multidisciplinary Clinical Research Center for Rheumatic Diseases in African Americans Save

Date Added
January 15th, 2013
PRO Number
Pro00021985
Researcher
Gary Gilkeson
Keywords
Autoimmune disease, Environmental Factors, Ethnicity and Disease, Genetics, Healthy Volunteer Studies, Lupus, Minorities, Rare Diseases, Scleroderma
Summary

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.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-8997
slans@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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