Newswise — WALTHAM, Mass., Aug. 10, 2021 /PRNewswire/ -- CorEvitas, LLC, the leading sponsor of registries in autoimmune and inflammatory diseases announces first patient enrollment in a new biospecimen study for patients enrolled in its rheumatology registries. Eligible rheumatology registry patients will contribute biological specimens that will be linked to longitudinal provider reported clinical and patient reported outcomes.
"We are excited to launch this biospecimen study to help advance the development of personalized therapies and diagnostics for rheumatology patients. We envision that this biospecimen study will enable us to uncover even deeper clinical insights from patients in order to improve care," said Austin Read, Vice President, Biospecimen Solutions.
CorEvitas previously conducted the largest and most comprehensive clinical study comparing the effectiveness of patients starting or switching biologic agents for rheumatoid arthritis in the CERTAIN [Comparative Effectiveness Registry to Study Therapeutics for Arthritis and Inflammatory Conditions] study. Through CERTAIN, over 80,000 longitudinal samples were collected from 2200 patients. The impact of the data captured and analyzed was significant, contributing to over 12 manuscripts to date, including studies of biomarkers to predict response to anti-TNF biologics.
The recently launched Rheumatology Precision Medicine Initiative will be used for various purposes, including to support the identification and validation of biomarkers predictive of drug toxicities, safety outcomes, and clinical response to specific therapies used for rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis conditions. Other objectives include research on biomarkers that describe disease activity or phenotypic disease subsets, and research to understand mechanisms of disease and comorbidities. Generated molecular data will provide a holistic snapshot of rheumatology patients by complementing the already available clinical and patient experiential data.
"We are incredibly appreciative to have such highly committed rheumatology investigators who have collaborated with CorEvitas for the CERTAIN study, capturing not only robust longitudinal clinical data on real-world effectiveness, but also an array of peripheral blood biospecimens. With our new JAK inhibitor precision medicine study, we anticipate advancing our understanding to predict which patients will be more likely to respond to JAK inhibitors," said Dr. Jeff Greenberg, Chief Medical Officer of CorEvitas.
CorEvitas will seek to enroll a minimum of 3,000 patients, leveraging its rheumatology network of over 85 sites. To learn more about this study and CorEvitas' biospecimen capabilities, visit www.corevitas.com/contact-us.
CorEvitas is the built for purpose gold-standard provider of real-world evidence. Through syndicated registry data and analytic services, CorEvitas helps biopharmaceutical companies demonstrate the value of their products to clinicians, patients, payers, and regulators. CorEvitas operates nine major autoimmune registries across the US, Canada, and Japan, collecting data from over 500 participating investigator sites. In addition to supporting hundreds of manuscripts and abstracts, CorEvitas has supported post approval safety commitments for multiple newly approved treatments in autoimmune diseases for both U.S. and European regulators. CorEvitas is headquartered in Waltham, MA. Its patient experience division, HealthiVibe, complements and strengthens the company's strong presence in disease registries by providing market-leading expertise in supporting innovative, evidence-based patient engagement initiatives across the product lifecycle. CorEvitas' HealthUnlocked technology platform hosts over 1.4M patients in hundreds of condition-specific communities and significantly expands the scope of patient experiential data. Through Health iQ, CorEvitas has access to a broad range of UK and international data sets across primary and secondary care, as well as deep relationships with the NHS and leading UK academic institutions. Vestrum Health, a leader in data analytics of retinal practice Electronic Health Records, provides insightful views of retinal diseases across the drug life cycle. CorEvitas is a portfolio company of Audax Private Equity.