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

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

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

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

Pathway Exploration and Analysis in Renal Lupus Save

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

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. Save

Date Added
January 24th, 2017
PRO Number
Pro00059452
Researcher
Dirk Elston
Keywords
Drug Studies, Lupus
Summary

Part A of the study is for people who have Systemic Lupus Erythematosus (SLE) and have active skin disease. This study will look at how well different doses of the study drug BIIB059 works in reducing active skin disease and other lupus manifestations in patients with SLE during 24 weeks of treatment. This study will also look at how well patients tolerate the doses of study drug being tested in this study and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.

Part B of the study is for people who have active cutaneous lupus erythematosus (CLE) with or without signs of systemic LE. This study will look at how well the study drug BIIB059 works in reducing skin disease in patients with CLE after 4 to 12 weeks of treatment. This study will also look at how well patients tolerate the study drug and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

A Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus Erythematosus Save

Date Added
December 20th, 2016
PRO Number
Pro00061632
Researcher
Gary Gilkeson
Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to evaluate the safety of mesenchymal stem cells (MSCs) obtained from an umbilical cord for the treatment of adults with systemic lupus erythematosus (SLE). The primary goal is to determine if a single MSC infusion is safe and well-tolerated for patients with mild to moderately active SLE.

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

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of two doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Save

Date Added
November 8th, 2016
PRO Number
Pro00060429
Researcher
Eric Zollars
Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to determine whether the addition of Anifrolumab (MEDI 546) to a patient's current Lupus treatment is effective in reducing Lupus disease activity.

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

Impact of Pathogenic and Protective Environmental Exposures on Autoimmune Disease Save

Date Added
January 19th, 2016
PRO Number
Pro00049624
Researcher
Diane Kamen
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
Angela Robinson
843-792-6043
robia@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus Save

Date Added
January 12th, 2016
PRO Number
Pro00050271
Researcher
Diane Kamen
Keywords
Autoimmune disease, Lupus
Summary

The primary objective of the trial is to evaluate the efficacy and safety of ustekinumab as measured by a reduction in disease activity for subjects with active SLE. All subjects will receive a body weight range-based IV administration of study agent (placebo or ustekinumab) at Week 0 and then sub cutaneous (needle) administration of placebo or ustekinumab at Weeks 8 and 16. All subjects will receive ustekinumab dosing at Weeks 24, 32, and 40. The study will last about one year, and will include 15 visits to the clinic. At each visit, the study team will monitor your symptoms and health. Patients who complete the trial may also qualify for an open-label extension of ustekinumab.

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

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