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
Megan Santilli
843-792-2509
santilli@musc.edu

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

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

List of Studies


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
Susannah Wakefield
843-792-5290
wakefies@musc.edu

Study of Anti-Malarials in Incomplete Lupus Erythematosus

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

List of Studies


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

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

List of Studies


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
Susannah Wakefield
843-792-5290
wakefies@musc.edu



-- OR --