Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease Save

Date Added
May 8th, 2018
PRO Number
Pro00077568
Researcher
Richard Silver

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Keywords
Autoimmune disease, Drug Studies, Lung, Scleroderma, Shortness of Breath
Summary

This study will assess how 18 months of oral mycophenolate will compare to 18 months of mycophenolate plus pirfenidone, in the treatment of Systemic Sclerosis related Interstitial Lung Disease. Tolerability and toxicity will also be assessed, during this study.
This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma related lung disease. This research is being funded by the drug company, Genentech.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

IDENTIFICATION OF ACCESSIBLE CHROMATIN MARKS IN ACTIVATED DENDRITIC CELLS FROM FEMALE AND MALE SLE PATIENTS Save

Date Added
November 16th, 2017
PRO Number
Pro00069599
Researcher
Melissa Cunningham

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Keywords
Autoimmune disease
Summary

Systemic lupus erythematosus (SLE, lupus) is an autoimmune disorder characterized by dysregulated immune responses and subsequent production of autoantibodies. In recent years, data suggests that changes in certain kinds of immune cells, dendritic cells, affect development of lupus.

Institution
MUSC
Recruitment Contact
John LeMay
843-792-5824
lemay@musc.edu

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study Save

Date Added
October 17th, 2017
PRO Number
Pro00070403
Researcher
Richard Silver

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Keywords
Autoimmune disease, Drug Studies, Scleroderma, Skin
Summary

This study is being conducted in order to test the safety of Brentuximab Vedotin in subjects with Diffuse Cutaneous Systemic Sclerosis. The study involves a Screening visit, a Baseline visit and 12 study visits occurring every 3 to 4 weeks, with enrollment lasting approximately 52 weeks, during which enrolled subjects will receive either the study compound or placebo.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@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

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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

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Orelvo (Voclosporin) (23.7 mg Twice Daily) with Placebo in Achieving Renal Response in Subjects with Active Lupus Nephritis Save

Date Added
September 26th, 2017
PRO Number
Pro00069657
Researcher
Melissa Cunningham

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Keywords
Autoimmune disease, Lupus
Summary

The primary objective of the study is to assess whether Orelvo, added to the standard of care treatment for patients with Lupus Nephritis, is able to reduce disease activity. The study will last for about 1 years and will involve 16 study visits. Patients who meet criteria will be assigned to one of two groups: One group will receive Orelvo 23.7mg taken twice a day by mouth, and the other will receive placebo. The study is blinded, with means neither the patient nor the study doctor will know what group subjects are in. Patients will be followed closely by the study doctors to determine their lupus activity levels over the course of 1 year.

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

A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects with Lupus Membranous Nephropathy (LMN) Save

Date Added
August 8th, 2017
PRO Number
Pro00068913
Researcher
James C. Oates

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Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to see if filgotinib and/or GS-9876 can be safe and helpful to treat patients with Lupus Membranous Nephropathy. These are both oral medications. The study will last for about one year and will involve 18 study visits. Patients will be assigned to get either filgotinib or GS-9876 at the beginning of the study. At Week 16, they will be evaluated to see if their LMN is improving. If so, they will remain on whichever drug they received. If not, they will switch to the other drug. At Week 32, patients will once again be evaluated. Based on those results, patients may remain on the same drug, or switch to the other group. This process will be blinded so that even though you will always be getting active drug, you will not know which one.

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

Study of Anti-Malarials in Incomplete Lupus Erythematosus Save

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

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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 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

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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

Pathway Exploration and Analysis in Renal Lupus Save

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

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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

Impact of Pathogenic and Protective Environmental Exposures on Autoimmune Disease Save

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

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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

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