Pathway Exploration and Analysis in Renal Lupus Save

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

Silhouette
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

Silhouette
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

Silhouette
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

Silhouette
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

Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis Save

Date Added
February 17th, 2015
PRO Number
Pro00040298
Researcher
Diane Kamen

Silhouette
Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

The primary objective of the study is to assess the safety of Belimumab following treatment with Rituximab and Cyclophosphamide in patients with Lupus Nephritis. The study will last for about 2 years and will involve 20 study visits. Patients who meet criteria will be assigned to one of two groups: Group 1 will have Rituximab plus Cyclophosphamide followed by Belimumab infusions, and Group 2 will have Rituximab plus Cyclophosphamide, but will not have the Belimumab infusions. This study is not blinded, so patients will know what group they are assigned to. Patients will be followed closely by the study doctors to determine their lupus activity levels over the course of 2 years.

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

An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients with Stable, Quiescent Systemic Lupus Erythematosus (SLE) Save

Date Added
December 17th, 2013
PRO Number
Pro00028738
Researcher
Diane Kamen

Silhouette
Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

This study is designed to look at the safety of taking patients whose lupus is not active off the immune suppression medication, Mycophenolate. It will involve two groups of lupus patients. One group will continue taking Mycophenolate Mofetil (MMF), and the other group will taper off their MMF. Both groups will be followed closely by study doctors to determine their lupus activity levels over the course of 16 months.

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

IRBIS: An International Registry for Biologics in Systemic Lupus Erythematosus (SLE). A prospective data collection. Save

Date Added
August 7th, 2012
PRO Number
Pro00018046
Researcher
Diane Kamen

Silhouette
Keywords
Lupus
Summary

The purpose of this research is to create a registry for patients with SLE who are seen by physicians at MUSC and have recently started a biologic therapy as a part of their routine care. This is not a drug study. Information about demographics, medical history, medication history, and clinical assessment forms will be gathered at entry into the study, 3 months, 6 months, and then yearly for 10 years or until the biologic therapy is discontinued (whichever comes first). This is a multi-site study and will have up to 2,000 participants total.

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

Systemic Lupus Erythematosus in Gullah Health (SLEIGH) Save

Date Added
October 5th, 2009
IRB Number
10852
Researcher
Diane Kamen

Silhouette
Keywords
Autoimmune disease, Children's Health, Environmental Factors, Ethnicity and Disease, Healthy Volunteer Studies, Immune System, Joint, Kidney, Lupus, Minorities, Non-interventional, Vitamin D, Women's Health
Summary

The Systemic Lupus Erythematosus (SLE) in Gullah Health, or SLEIGH, study is an observational study enrolling African Americans from the Sea Island communities of South Carolina and Georgia. We are enrolling patients, family members of patients, and unrelated community members. SLE is a potentially severe disease that can affect the entire body. SLE is more common in African Americans than Caucasians. The main purpose of this study is to find genes that, along with factors from the environment, result in the development of SLE. Volunteers in SLEIGH will be asked to answer questions about their health and have blood and urine collected for tests. After the first visit there may be one additional visit 2 or more years later. This is not a drug study.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-8997
slans@musc.edu

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