Thermo Fisher Scientific Launches CorEvitas Clinical Registry and Biorepository in Systemic Lupus Erythematosus
WALTHAM, Mass. – Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of the CorEvitas Systemic Lupus Erythematosus (SLE) Registry. The multi-center, prospective registry leverages the CorEvitas rheumatology physician network and addresses a critical unmet need for collecting robust, objective real-world data about this chronic and devastating autoimmune disease, in which the immune system attacks healthy tissue and can cause damage to patients’ skin, joints, blood and internal organs, including the kidneys, heart, brain and lungs. The registry will leverage clinician and patient insights to address key questions about the safety and effectiveness of available and future treatments for SLE, the most common type of lupus.
Patients diagnosed with SLE experience symptoms ranging from mild to severe or even life-threatening, and commonly include extreme fatigue, joint and muscle pain, headache, fever, alopecia and sensitivity to light. Approximately 90% of SLE patients are women. The exact cause is unknown, however it is believed that environmental, genetic and hormonal factors can contribute. SLE can affect many parts of the body, and symptoms often manifest differently across patients and fluctuate over time, making diagnosis and treatment difficult. A small number of biologics have recently been approved to treat SLE, with an exciting array of targeted and cellular therapies in development.
The registry collects clinical data longitudinally from both enrolled patients and their treating rheumatologists across multiple health outcome domains, including drug utilization, quality of life, disease activity and severity, medical comorbidities, diagnostic tests and adverse events. With a large, clinically rich data set and a supporting team of experts in epidemiology, biostatistics and drug safety at their fingertips, researchers can derive unique insights to address a range of critical questions related to the treatment of SLE.
“This independent, multi-drug registry and linked biorepository fill a critical gap for our clients and the broader research community, particularly as newer therapies and treatment paradigms are prescribed,” said Jeffrey Greenberg, M.D., chief medical officer, CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific. “High-quality, real-world data can drive much-needed insights on novel treatments and provide hope for patients suffering from this chronic illness.”
This is the 13th independent CorEvitas registry, building on a robust rheumatology network and foundational efforts to address unmet research needs in rheumatological conditions. As the U.S. has the second-highest incidence of SLE globally, the registry will consist of SLE patients in North America under the care of a rheumatologist. It is complemented by a CorEvitas SLE biorepository, which collects blood specimens linked to clinical data from enrolled registry patients to support a range of additional use cases, including drug discovery and development, as well as the development of biomarkers to predict disease progression and drug response. This registry was launched with the scientific guidance of advisors Anca Askanase, M.D., MPH, professor of medicine, Columbia University Medical Center, and George Tsokos, M.D., professor of medicine, Harvard Medical School.
CorEvitas services 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 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 this study and the newly launched registry, request information at [email protected].
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.
