The Implementation of Decision Aid for Lupus Patients in Practice Settings for Shared Decision-Making (SDM): IDEAL Study Save

Date Added
July 23rd, 2019
PRO Number
Pro00086269
Researcher
Diane Kamen

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Profiles_link
Keywords
Autoimmune disease, Lupus
Summary

The purpose of this research study is to evaluate the value of educational information given on an iPad about the risks and benefits of lupus medications. The information is intended to encourage conversations between the patient and doctor about lupus treatments. This research will test the feasibility and effectiveness of using the iPad in lupus clinics nationwide. Participants will be given information about lupus treatments on an iPad during the clinic visit before seeing their doctor and will be interviewed about the feasibility of using the iPad during a regular clinic visit.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
843-792-5290
lupusresearch@musc.edu

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis Save

Date Added
June 25th, 2019
PRO Number
Pro00088593
Researcher
Eric Zollars

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Profiles_link
Keywords
Lupus
Summary

The purpose of this study is to see if a new medicine named BMS- 986165 will treat kidney inflammation caused by lupus (lupus nephritis). This study is a clinical trial?which is how new medicines are studied before they are approved by the FDA. This particular drug targets the JAK/STAT pathway to reduce autoimmunity and inflammation.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash, sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (for example prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for lupus.

Institution
MUSC
Recruitment Contact
Amanda Pizzo
843-792-8613
pizzo@musc.edu

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Save

Date Added
October 24th, 2018
PRO Number
Pro00077684
Researcher
Eric Zollars

List of Studies


Profiles_link
Keywords
Autoimmune disease, Lupus, Skin
Summary

The purpose of this research study is to measure how well and how safe BMS-986165 is in treating patients with Systemic Lupus Erythematosus (SLE) and to determine the optimal dose level.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash (redness of the skin), sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for Lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (such as prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for Lupus.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@musc.edu

Role of Gut Microbial Translocation in Initiating Autoimmunity Save

Date Added
October 16th, 2018
PRO Number
Pro00082453
Researcher
Gary Gilkeson

List of Studies


Profiles_link
Keywords
Lupus
Summary

The purpose of this study is to better understand how microorganisms move through the walls of the intestine and cause a response by the immune system, and how these differences affect lupus (Systemic Lupus Erythematosus, or SLE). The study involves a single visit where blood and saliva samples will be collected, and you will be sent home with a gut permeability test (which involves drinking a liquid and collecting urine samples) and a stool sample collection test that you will collect and mail in yourself.

Institution
MUSC
Recruitment Contact
John LeMay
843-789-6799
lemay@musc.edu

Role of microbiota-TLR7/8 Interaction in systemic lupus erythematosus Save

Date Added
September 5th, 2018
PRO Number
Pro00079851
Researcher
Chenthamarakshan Vasu

List of Studies


Profiles_link
Keywords
Autoimmune disease, Immune System, Inflammation, Lupus
Summary

The goal of this study is to learn more about lupus (Systemic Lupus Erythematosus; SLE), which affect African-Americans more than other groups. The purpose of this study is to understand what role microbes living in the intestine (called microbiota) have in causing lupus. This study will include African-Americans who have SLE, individuals who have immediate family members with SLE and unrelated healthy volunteers. For study subject recruitment, CCCR/MCRC databases including the longitudinal SLE in Gullah Health (SLEIGH) study as well as the chart review will be used to screen for eligibility. The study is sponsored by the National Institutes of Health.

Institution
MUSC
Recruitment Contact
Tyler Malone
843-792-5935
malonety@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

List of Studies


Profiles_link
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
Daniel Melcher
843-792-2509
melcher@musc.edu

Pathway Exploration and Analysis in Renal Lupus Save

Date Added
July 18th, 2017
PRO Number
Pro00067258
Researcher
Diane Kamen

List of Studies


Profiles_link
Keywords
Autoimmune disease, Kidney, Lupus
Summary

The purpose of the study is to characterize the inflammatory response in lupus nephritis kidneys in order to identify the cellular and molecular pathways of injury. It will involve patients who are already scheduled to have a kidney biopsy to clarify the diagnosis of lupus nephritis and/or to guide therapy. During the biopsy, doctors will take an extra "core" of kidney tissue for research purposes in addition to the one used for clinical reasons. If you enroll in the trial, you will have 7 visits, including your kidney biopsy. The first two visits occur within 2 weeks, then follow up visits after 3, 6, 12, 18 and 24 months.

Institution
MUSC
Recruitment Contact
Margaret Lindemuth
843-792-8613
hardinm@musc.edu

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (Protocol ALE09) Save

Date Added
July 18th, 2017
PRO Number
Pro00063016
Researcher
Diane Kamen

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Inflammation, Lupus
Summary

This double-blinded placebo-controlled research study is being done to test the effectiveness, safety, and tolerability of the experimental drug JBT-101 in patients with systemic lupus erythematosus (SLE). We will see if JBT-101 taken by mouth stops inflammation and how well JBT-101 is tolerated. The study will evaluate whether JBT-101 will decrease the pain associated with active arthritis or tendonitis in SLE subjects. JBT-101 is manufactured entirely from chemicals and its structure is similar to the end product of a chemical in marijuana. This drug was designed to have the known anti-inflammatory properties of marijuana without the effects on brain function and mood.

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

Study of Anti-Malarials in Incomplete Lupus Erythematosus Save

Date Added
July 18th, 2017
PRO Number
Pro00060015
Researcher
Diane Kamen

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

The primary objective of the trial is to assess the ability of hydroxychloroquine to prevent the development of SLE in persons at risk for the disease. Subjects will be assigned to one of two groups: one with receive oral hydroxychloroquine, and one will receive oral placebo. The study lasts for about two years, with visits being once every 3 months, for a total of 12 visits. Two of those visits will be with an ophthalmologist to monitor eye health. At each visit, the study team will monitor your symptoms and health.

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

Impact of Pathogenic and Protective Environmental Exposures on Autoimmune Disease Save

Date Added
January 19th, 2016
PRO Number
Pro00049624
Researcher
Diane Kamen

List of Studies


Profiles_link
Keywords
Autoimmune disease, Healthy Volunteer Studies, Lupus
Summary

This study is a one-time visit for newly diagnosed lupus patients and healthy control subjects. Volunteers will be asked to answer questions about their medical, social, and diet history. Participants will also have blood, urine, and stool samples collected for testing. The purpose of this study is to understand what role organisms in the human gut and environmental exposures have on the development of autoimmune disease. This is not a drug study.

Institution
MUSC
Recruitment Contact
Trevor Faith
843-792-8997
faitht@musc.edu

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