Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease Save

Date Added
May 8th, 2018
PRO Number
Pro00077568
Researcher
Richard Silver

Silhouette
Keywords
Autoimmune disease, Drug Studies, Lung, Scleroderma, Shortness of Breath
Summary

This study will assess how 18 months of oral mycophenolate will compare to 18 months of mycophenolate plus pirfenidone, in the treatment of Systemic Sclerosis related Interstitial Lung Disease. Tolerability and toxicity will also be assessed, during this study.
This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma related lung disease. This research is being funded by the drug company, Genentech.

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

IDENTIFICATION OF PERIPHERAL BLOOD CELL SUBSETS DYSREGULATED IN LUPUS AND SCLERODERMA Save

Date Added
October 17th, 2017
PRO Number
Pro00069048
Researcher
Paula Ramos

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Keywords
Autoimmune disease, Immune System, Lupus, Scleroderma
Summary

Often considered as related diseases, systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) are severe autoimmune disorders characterized, among other, by dysregulation of immune cells in the blood. The roles of different immune cells in SLE and SSc remain unclear. It is of increasing importance to characterize specific immune cells and define their impact on autoimmune disease, which may lead to new therapies. The goal of this study is to identify blood immune cells associated with SLE and SSc.

Institution
MUSC
Recruitment Contact
John LeMay
843-792-5824
lemay@musc.edu

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

Silhouette
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

Targeted therapy for scleroderma skin fibrosis Save

Date Added
October 2nd, 2017
PRO Number
Pro00070318
Researcher
Carol Feghali-bostwick

Silhouette
Keywords
Scleroderma
Summary

Patients with more severe forms of scleroderma skin disease will be recruited within 7 years of the onset of their scleroderma symptoms. Two, small skin biopsy samples will be obtained from these patients. These biopsies will be placed in a culture to allow them to grow and thrive. Typically, skin biopsy tissue from patients with scleroderma produce larger amounts of skin-thickening collagen. This extra collagen leads to a process known as fibrosis, which can be noticed by patients as thickening and hardening of the skin. Potential medications will be tested in these cultures to see if they reduce the amount of skin-thickening fibrosis produced by the skin tissue from these biopsies. The overall goal of this project is to identify potential medications that could be tested later for treatment of patients with scleroderma to reduce skin fibrosis.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5920
gibsonke@musc.edu

Development of CSD-Based Therapies: Novel Indications and Improved Versions of CSD Save

Date Added
September 26th, 2017
PRO Number
Pro00069613
Researcher
Stanley Hoffman

Silhouette
Keywords
Heart, Lung, Lupus, Scleroderma
Summary

We have already observed that the blood cells known as monocytes from patients with the fibrotic disease scleroderma behave differently from monocytes from healthy controls. Here we will test whether patients with other fibrotic diseases also have altered monocyte function. Specifically, we will get blood from congestive heart failure and lupus patients and compare their monocytes to scleroderma patient and healthy subject monocytes. Our recent results in a mouse model for congestive heart failure suggest that we will find altered monocyte behavior in human congestive heart failure patients.

Institution
MUSC
Recruitment Contact
Elena Tourkina
843-792-7319
tourkine@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

Silhouette
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

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

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry Save

Date Added
November 3rd, 2015
PRO Number
Pro00048606
Researcher
Natasha Ruth

Silhouette
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

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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