A Multicenter, Open-Label Study To Estimate The Effect Sizes Of HRCT Endpoints In Response To Glucocorticoid Induction Therapy In Subjects With Pulmonary Sarcoidosis Save

Date Added
September 25th, 2018
PRO Number
Pro00081796
Researcher
Walter James
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this study is to compare an imaging procedure called high-resolution computed tomography (HRCT) against the standard pulmonary function tests (PFTs) to see if HRCT is better at showing if the standard glucocorticoid treatment is working. This study also includes testing of blood samples for biomarkers which are measurable indicators of the severity or presence of some disease state. The maximum time you will be in the study is 3 months. During this time, you will need to visit the study site 6 times for 6 site study visits. This study will enroll subjects with a diagnosis of pulmonary sarcoidosis at stage II or III who have shortness of breath (dyspnea) and have not received prednisone or prednisolone (glucocorticoids) treatment or other sarcoidosis therapy within the last three months.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

Human Samples Bio Repository Save

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica Del monte
Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

A Phase 4 Multicenter, Randomized, Double Blind, Placebo Controlled Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects with Pulmonary Sarcoidosis Save

Date Added
June 26th, 2018
PRO Number
Pro00078345
Researcher
Walter James
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this research study is to find out if Acthar works well in and is safe when you use it as part of the treatment for your Pulmonary Sarcoidosis. This research study will collect additional data as to the effectiveness and safety of Acthar in treating Pulmonary Sarcoidosis, and will examine how the study drug acts in the body and how well it manages your symptoms. Participation could last for approximately 56 weeks. This will include a Screening Period that will last up to 4 weeks, a double-blind treatment period of about 6 months when neither you nor your study doctor will know if you are taking Acthar or placebo, an open-label treatment period of about 6 months, and a follow-up visit at about 4 weeks after the last dose of the study drug. The study plan includes coming to the study doctor's research center at least 12 times if you participate throughout the whole study duration of 56 weeks or 9 times if you participate only in the double-blind period.
Approximately 100 people will participate in this study.

Institution
MUSC
Recruitment Contact
Daniel Larimore
(843) 792-6890
larimord@musc.edu

Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial Save

Date Added
June 22nd, 2017
PRO Number
Pro00067313
Researcher
Walter James
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

You are being asked to take part in this research study because you have been diagnosed with pulmonary sarcoidosis. Sarcoidosis is a disease that can affect the lungs, skin and other organs of the body. Sarcoidosis also involves immune cells which fight bacteria. The purpose of this study is to see if using specific antibiotics will help these immune fighting cells get rid of bacterial proteins and how the antibiotics affect respiratory (breathing) function. The antibiotics used in this study are Levaquin, Ethambutol, Azithromycin, and either Rifampin or Rifabutin. You will by chance be assigned either these medicines or a placebo (an inactive substance).

Institution
MUSC
Recruitment Contact
Kelly French
843-792-3169
frenchke@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 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

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