Mount Sinai has the largest Sarcoidosis Service in the world and is one of only two institutions in the country participating in the trial; the other is the University of Cincinnati. Mount Sinai is a National Institutes of Health Center of Excellence for research in sarcoidosis.
"The current standard treatment for chronic pulmonary sarcoidosis is corticosteroids," said Adam Morgenthau, MD, principal investigator of the study and Director of the Sarcoidosis Clinic and the Alvin S. Teirstein Sarcoidosis Support Group at Mount Sinai. "Many patients don't respond to these drugs and those who do often develop long-term complications. We are hopeful this study will lead to new treatments to improve lung function and quality of life."
Sarcoidosis is a rare inflammatory disease that can affect any organ but most commonly involves the lungs. Patients with pulmonary sarcoidosis typically exhibit symptoms of shortness of breath, cough and/or wheeze. It affects men and women of all ages and races worldwide. However, it occurs mostly in people ages 20 to 40, African Americans, especially women, and people of Asian, German, Irish, Puerto Rican and Scandinavian origin, according to the National Institutes of Health.
The randomized placebo Phase II clinical trial at Mount Sinai for patients with sarcoidosis is designed to assess the safety, tolerability and efficacy of an antibody directed against macrophage colony-stimulating factor (m-CSF), a protein associated with the development of sarcoidosis. During a Phase I clinical trial for patients with rheumatoid arthritis (RA), the antibody was well tolerated in healthy people as well as patients with RA.
"This study has both clinical and basic science applications," said Dr. Morgenthau. "In addition to determining whether patients' symptoms improve with this treatment, we will examine cell signaling pathways and immune responses in the trial participants which will help us better understand the biology of sarcoidosis and ultimately lead to the development of therapies that target the immune response."
To be eligible for the study, patients must be taking corticosteroids daily for chronic pulmonary sarcoidosis and lung impairment. As many as 90 accepted patients will receive infusion therapy every two weeks for 12 weeks, take CT and PET scans and submit questionnaires. Patients interested in participating in the trial should contact the Clinical Trials Office at 212-241-9538 or visit http://www.mssm.edu/research/resources/office-of-clinical-research.
The Phase I and II clinical trials have been funded by Pfizer.
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