Reference Range and Clinical Performance Evaluation of Elecsys IL-6 Assay in Neonatal Sepsis (US); Collection Study.

Date Added
June 22nd, 2022
PRO Number
Pro00119546
Researcher
Gary Headden

List of Studies


Keywords
Autoimmune disease
Summary

The study is an experimental laboratory test (Interleukin-6, abbreviated IL-6) for infection in your blood, called IL-6 Neonates_US. An IL-6 test is a laboratory test that has not been approved by the regulatory authorities, such as the U.S. Food and Drug Administration (FDA) in your country. The results from experimental laboratory test used in this study will not be used to make a diagnosis or guide therapy.

Institution
MUSC
Recruitment Contact
Aja Bayo
18437927944
bayo@musc.edu

Alpha-1 Antitrypsin Disease Cohort: Longitudinal Biomarker Study of Disease Consortium

Date Added
March 16th, 2022
PRO Number
Pro00117423
Researcher
Charlie Strange

List of Studies


Keywords
Autoimmune disease, Liver, Lung, Non-interventional, Pulmonary, Rare Diseases
Summary

The purpose of this study is to create a de-identified, public use,
repository of data of Chronic Obstructive Pulmonary Disease (COPD)
patients with by Alpha-1 antitrypsin deficiency (AATD), a rare genetic
condition that can cause COPD and emphysema.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis

Date Added
March 8th, 2022
PRO Number
Pro00112238
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The purpose of this study is to see if nipocalimab is safe and useful for treating Adults with Generalized Myasthenia Gravis. Myasthenia gravis (MG) is a rare disease that affects the muscles and brain; causes tiredness and weakness in the eye muscles, arms, legs, and neck, and may cause difficulty with breathing. You must be diagnosed with myasthenia gravis to be in this study. Another purpose of this study is to find out how long nipocalimab stays in and acts on your body. This is measured by blood tests. Another purpose is to find out if nipocalimab can cause side effects, which are unexpected or unwanted reactions from taking a drug.

Participants will first be enrolled into the Double-Blind Placebo-Controlled Treatment Period which will last for about 24 weeks. Participants in this period of the study will receive either nipocalimab or a placebo through an infusion (IV). Participants with come for an office visit every 2 weeks to obtain the infusion, complete questionnaires, perform safety assessments and lab tests.

At the end of the Double-Blind treatment period, your study doctor will determine if you are eligible to enroll in the Open-Label Extension (OLE) period in which you would be able to receive nipocalimab infusions for approximately 2-5 years. There also may be a chance you did not participate in the Double-Blind Treatment Period of this study but can still enroll in the Open-Label Extension. Participants will complete the same activities in the OLE has the Double-Blind Placebo-Controlled Treatment Period.

The total amount of time the subject would be on the study is about 6 months for the Double-Blind Placebo-Controlled Treatment Period with an additional 2-5 years for the Open-Label Extension (OLE) period.

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-2845
choudhur@musc.edu

Daily Topical Rapamycin Therapy for the Treatment of Vitiligo

Date Added
March 1st, 2022
PRO Number
Pro00115924
Researcher
Ahmad Aleisa

List of Studies

Keywords
Adolescents, Autoimmune disease, Pediatrics, Skin
Summary

In current Dermatology practice, options for vitiligo remain limited. The purpose of this study is to determine if once daily dosed topical rapamycin is effective for the treatment of patients with vitiligo. Participants will apply either 0.1% topical rapamcyin or 0.001% topical rapamycin for six months to a lesion on one side of the body, and topical placebo to a corresponding lesion on the opposite side of the body. The study also aims to evaluate patient satisfaction and identify any adverse effects on these dosing regimens.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)

Date Added
February 22nd, 2022
PRO Number
Pro00117883
Researcher
Richard Silver

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma, Skin
Summary

The purpose of this study is to test whether a drug called PRA023 (the study drug) is a good treatment for patients with Systemic Sclerosis associated with Interstitial Lung Disease (SSc-ILD). The study drug PRA023 is an investigational drug that is given by infusion every 4 weeks. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, PRA023 will be compared with a placebo (dummy drug). The placebo will be a saline solution that does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of the PRA023 or not. This is a randomized study meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. This will be done with the help of a computer-based program and you will have 50% chance of receiving either the study drug or placebo. The study is double-blinded study and 50 weeks long, meaning you and your study doctor will not know what you are receiving, the study drug or placebo.

The study is sponsored by Prometheus Biosciences, Inc. The study is being done at approximately 25 sites across the United States. The main portion of the study will require 15 visits to the MUSC main campus and will have the following procedures completed over the course of your participation: blood draw, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as asked to complete surveys. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-8613
frasibri@musc.edu

The role of estrogen receptor alpha variant size and localization in modulating TLR7-induced inflammation.

Date Added
January 21st, 2022
PRO Number
Pro00113082
Researcher
Melissa Cunningham

List of Studies


Keywords
Autoimmune disease, Healthy Volunteer Studies, Lupus
Summary

This observational, non-medication study's purpose is to help learn more about the immune system's inflammation process involved in lupus. The study will be enrolling both lupus and non-lupus (healthy control) females aged 18 and older who identify as Black/African American and Non-Hispanic or White and Non-Hispanic for this comparison study. Participation involves a one-time blood collection.

There are no direct benefits in participating, but it is hoped information learned may help us to develop a better understanding of lupus. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Kimberly King
843-792-2509
kingkim@musc.edu

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Date Added
September 14th, 2021
PRO Number
Pro00110634
Researcher
Richard Silver

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma, Skin
Summary

The purpose of this study is to obtain information on the safety, efficacy, and tolerability of an oral drug called HZN-825 for the treatment of diffuse cutaneous systemic sclerosis (dcSSc) in participants 18-75. The study drug is taken as a tablet twice a day for 52 weeks. This study has 12 planned visits over a 60 week period. The study will measure the improvement, stabilization or worsening of your symptoms, such as changes in your fatigue and pain levels, lung function, skin thickness and other participant reported outcomes.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-8613
frasibri@musc.edu

National Institute of Allergy and Infectious Diseases (NIAID) "BOOSTER EFFECTS WITH AUTOIMMUNE TREATMENTS IN PATIENTS WITH POOR RESPONSE TO INITIAL COVID-19 VACCINE"

Date Added
September 7th, 2021
PRO Number
Pro00113395
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Coronavirus, Lupus, Rheumatoid, Scleroderma, Vaccine
Summary

This research is being done to see if an additional shot of COVID-19 vaccine, called a "booster", will help people with autoimmune disease who are taking medications that weaken their immune system develop a better response to the vaccine. The study is also being done to see if temporarily stopping the medication you take for your autoimmune disease will help your immune system have a positive response to the vaccine booster.

This study will use the COVID-19 vaccines that are authorized under an Emergency Use Authorization by the United States Food and Drug Administration (FDA) for initial vaccination, but they are not currently authorized or approved to be used as booster vaccinations – so their use in this study is experimental. This includes the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines.

This study is enrolling people over the age of 18 who have a diagnosis of lupus, scleroderma, or rheumatoid arthritis. You will be asked to come to the clinic for up to 8 research visits over 13 months. There might be no direct medical benefit to you for being in this study. The information learned from this study may someday benefit people with autoimmune disorders. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Stephanie Bray
843-792-8997
brays@musc.edu

Social factors, epigenomics, and lupus in African American women (SELA)

Date Added
August 17th, 2021
PRO Number
Pro00112945
Researcher
Paula Ramos

List of Studies