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Sarcoidosis Clinical Trials

The Susan Pearlstine Sarcoidosis Center of Excellence at MUSC conducts cutting edge research in sarcoidosis that improves the lives of patients by learning more about potential causes and treatment options. Conducting research is vital, and the success of research is dependent on having informed and engaged patients. Below you will find a general description of the types of research we perform, as well as the specific research studies that are currently available to our sarcoidosis patients.

What is a clinical trial?

Clinical trials are studies that look at new ways to prevent, detect, or treat disease. Treatments might be new medications, new surgical procedures or devices, or even new ways to use existing treatments. Clinical trials are necessary to understand if the new treatment is effective, but also to prove that it is generally safe.

Why might I participate in a clinical trial?

The main reason to participate in a clinical trial is to help someone. That someone might be yourself because you are hoping to find a new treatment that works for you. Some might participate because it will help others, such as a family member, or others suffering from the same condition. Even healthy volunteers say they participate to help others, as they have nothing to gain from the therapy itself.

We owe a huge debt to those who have volunteered for clinical trials. Everyone has taken a medicine at some time in their life, whether prescribed by a doctor or obtained over-the-counter. We should recognize that somebody volunteered for studies of that medicine and for our benefit.

How do I know that clinical trials are safe?

There is a long road before a new therapy is ready for human trials. There must be testing in the laboratory before the FDA will allow for studies to begin in humans. An Institutional Review Board (IRB) reviews the study application and all materials prepared for the study to assure that your rights and safety have been addressed. There is also constant monitoring by the investigative team as well as central reviewers and a Data Safety Monitoring Committee, who reviews data periodically, to assure there are no safety issues out of the ordinary.

How do I find what clinical trial is right for me?

Not all clinical trials are a good fit for everybody. Some clinical trials are short and intense, with frequent and long study visits, while others may last for many months, but do not require so many visits. The medication or therapy being studied should be of interest to you, and then you can discuss the schedule to know if it would work with your other activities.

How do I find out more about clinical trials?

There are several ways to learn more about clinical trials ongoing at MUSC. You can access SCresearch.org to find trials that would be of interest to you. Ask your doctor about available clinical trials. You can also contact the MUSC Pulmonary Clinical Trials office at 843-792-4349 or jonesash@musc.edu.

Active Clinical Trials

The purpose of this research study is to find out if Acthar works well in and is safe when you use it as part of the treatment for your Pulmonary Sarcoidosis. This research study will collect additional data as to the effectiveness and safety of Acthar in treating Pulmonary Sarcoidosis, and will examine how the study drug acts in the body and how well it manages your symptoms. Participation could last for approximately 56 weeks. This will include a Screening Period that will last up to 4 weeks, a double-blind treatment period of about 6 months when neither you nor your study doctor will know if you are taking Acthar or placebo, an open-label treatment period of about 6 months, and a follow-up visit at about 4 weeks after the last dose of the study drug. The study plan includes coming to the study doctor's research center at least 12 times if you participate throughout the whole study duration of 56 weeks or 9 times if you participate only in the double-blind period.

Sponsor: Mallinckrodt Pharmaceuticals Study

Contact: Ashley Warden
843-792-4349
jonesash@musc.edu

This study is being done to learn more about the safety of the drug ATYR1923, to see if taking this drug ATYR1923 will allow you to reduce your steroid dose, and to find out more about the effects of different doses of this drug on the lungs of people who have pulmonary sarcoidosis. This study will also look at how the body responds to the drug. These things will be measured by taking samples of your blood, through medical examinations performed by your study doctor, by lung function tests and by reviewing images of your lungs. This study also includes taking blood samples for biomarkers, antibodies, and tryptase and complement levels. A skin lesion biopsy portion of the study is optional. Participation will last up to 28 weeks. You will have a total of 7 study site clinic visits and 8 telephone contacts during the treatment period.

Sponsor: aTyr Pharma, Inc Study

Contact: Ashley Warden
843-792-4349
jonesash@musc.edu

The purpose of this research study registry is to identify patients with advanced sarcoidosis. This is an observational research study, which means you will not take study medication(s). The study will determine how many and how often patients are diagnosed with advanced disease in sarcoidosis clinics. The study will determine how many and how often patients are diagnosed with advanced disease in sarcoidosis clinics. This study will look at genetic markers; determine the risk factors for advanced sarcoidosis and the natural course of symptoms in advanced disease. You will be in the research study for approximately 36 months (3 years) and will be seen every 6 (six) months during the research study.

Contact: Ashley Warden
843-792-4349
jonesash@musc.edu

This is a trial for cardiac sarcoidosis in patients seen during routine clinical care who have not been clinically suspected to have cardiac sarcoidosis according to conventional criteria. The addition of echocardiogram and ambulatory ECG to usual clinical follow-up will be compared. This is a multicenter study, coordinated by the Foundation for Sarcoidosis Research. Up to 12 sites in the US and Europe will participate. Each site will enroll 50 consecutive consenting individuals to a total of 600 enrolled subjects in a randomized trial of additional screening versus usual care.

Contact: Ashley Warden
843-792-4349
jonesash@musc.edu