SPHERES Registry Launching to Help Improve Patient Care

CorEvitas and the Guthy-Jackson Charitable Foundation (GJCF) announced plans to launch a registry study for people with neuromyelitis optica spectrum disorder (NMOSD).

Called SPHERES — which stands for Synergy of Prospective Health & Experimental Research for Emerging Solutions in NMOSD — the observational study is expected to enroll 750 NMOSD patients.

Participants’ detailed background, clinical data, and biological samples will be collected and analyzed to help improve care in this patient population. CorEvitas and GJCF are currently inviting sites and patients to join the registry.

“The SPHERES Registry will serve as a comprehensive real-world study to advance our knowledge of NMOSD in ways that directly help patients,” Michael Yeaman, PhD, professor of medicine at the David Geffen School of Medicine of the University of California, Los Angeles, and chair medical advisor to the GJCF, said in a press release.

“Importantly, its focus will include safety and effectiveness of newly approved medications, evolving treatment patterns and access, and understanding patient experience over time,” Yeaman said, adding that the study will also look at potential cellular and molecular biomarkers of the disease.

The registry study is also supported by Genentech, a Roche subsidiary; other industry partners are welcomed to join the collaboration.

“We are excited and truly honored to partner with GJCF on this collaborative research initiative, further demonstrating our deep commitment as a company to accelerating real-world evidence generation in neurologic diseases,” said Jeff Greenberg, MD, chief medical officer of CorEvitas, a sponsor of registries in autoimmune and inflammatory diseases.

In people with NMOSD, a rare neuroinflammatory autoimmune disease, the immune system wrongly produces antibodies that attack proteins at the surface of astrocytes and oligodendrocytes — cells that support the nervous system — causing inflammation in the optic nerve and spinal cord.

Most NMOSD patients have high levels of antibodies against the protein aquaporin-4 in astrocytes.

The disease is estimated to affect about 15,000 people in the U.S. and hundreds of thousands worldwide. Recent advances in diagnosis and biomarkers, as well as the approval of new therapeutic options, offer patients with NMOSD the ability to lessen or prevent disability and improve quality of life.

SPHERES’s data will be managed and analyzed by CorEvitas’s scientific experts in clinical research, epidemiology, and biostatistics. Epidemiology is the study and analysis of the distribution, patterns, and determinants of health-related states and diseases in specified populations.

Advisors from GJCF will serve on the study’s scientific steering committee and facilitate state-of-the art research, building on the success and insights generated by the GJCF-led CIRCLES registry, the largest multicenter NMO study in the world.

Standing for Collaborative International Research in Clinical and Longitudinal Experience for NMOSD Studies, CIRCLES enrolled 1,100 NMOSD patients, controls with other autoimmune or central nervous system diseases, and healthy volunteers in North America.

Clinical data and biological samples from each participant are being collected every two years to help better understand NMOSD’s underlying mechanisms, clinical course, and treatment effects.

To learn more about the SPHERES registry, contact CorEvitas.