Thermo Fisher Scientific Inc., the world leader in serving science, today announced the enrollment of the first patient in the new PPD™ CorEvitas™ Myasthenia Gravis (MG) Registry. This nationwide registry will collect data from MG patients across the United States to study and evaluate existing and emerging MG therapies, tracking health conditions, safety issues, medication usage and overall treatment effectiveness. By leveraging real-world data, the registry will enhance our understanding of MG and improve patient care.
MG is a rare autoimmune disorder of the neuromuscular junction causing muscle weakness and fatigue that worsens with activity and may fluctuate daily. While more common in adults, MG can affect people of all ages, and the exact cause is unknown. It is estimated that over 70,000 people in the U.S. have been diagnosed with MG. Patients can experience a wide range of symptoms that can vary from mild to severe and may include periods of remission with no symptoms, severe episodes that worsen with daily activities, or myasthenic crisis, which involves severe muscle weakness affecting breathing or swallowing, requiring medical support such as intubation or ventilation. There's currently no way to prevent or cure MG, but treatment can help manage symptoms.
The registry is designed to collect clinical data from enrolled patients under the care of a neurologist in both academic and private practice settings. The registry is now active in the U.S., with the first patient enrolled on November 10.
"The CorEvitas MG Registry will enroll and follow patients with both ocular and generalized forms of MG. Data collected prospectively in this new clinical registry will enable us to study progression of disease and evaluate the safety and effectiveness of medications used in the treatment of generalized MG. It will also help us understand the impact of the disease with respect to clinical burden as well as from the patient perspective,” said Peter Wahl, Sc.D, vice president and global head of scientific affairs for PPD CorEvitas Clinical Registries, Thermo Fisher Scientific. “As with all of our registries, our aim is to build an infrastructure that supports a long-term commitment to regulatory grade data collection, advancing real-world research and improving lives for patients diagnosed with MG."
This registry was launched under the scientific guidance of James Howard, M.D., professor of neurology, medicine and allied health, University of North Carolina at Chapel Hill; and Michael Benatar, M.D., Ph.D., professor of neurology and public health sciences, University of Miami Health System. This is the 14th independent registry from PPD™ CorEvitas™ Clinical Registries, part of the PPD clinical research business of Thermo Fisher Scientific.
CorEvitas Clinical Registries solutions include proprietary autoimmune and inflammatory disease registries containing structured, regulatory-grade patient clinical data spanning more than 500 investigator sites and over 100,000 patients followed longitudinally. The CorEvitas Clinical Registries independent registry model has been accepted by regulators for long-term post-authorization safety studies across a variety of disease indications.
To learn more about CorEvitas Clinical Registries and this newly launched registry, request information at MGRegistry@thermofisher.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
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Thermo Fisher Scientific
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