The nonprofit organization Accelerated Cure Project for Multiple Sclerosis is going to sponsor the launch of the Optimizing Treatment – Understanding Progression (OPT-UP) study in collaboration with biopharmaceutical company EMD Serono, Inc, a subsidiary of the german Merck KGaA. The study will enroll 2,500 MS patients, which will be followed for five years in order to understand the main treatment outcomes suffered.
The new agreement is aimed at supporting the creation of a database of the factors that afflict MS patients regarding treatment outcomes through a U.S.-based, multicenter longitudinal clinical research. The purpose of the study is to help physicians in their therapeutic decisions and interventions, as well as provide knowledge and tolls for the development of new strategies and treatments for MS.
“We have been working diligently with leading MS clinicians, people living with MS, biopharma companies, and foundations to design a study that addresses the most critical medical needs in MS today,” stated the president and CEO of the Accelerated Cure Project for MS, Robert McBurney. “We are thrilled that EMD Serono, a leader in the area of MS therapeutics, has chosen to take a lead founding sponsor role, providing the support needed to implement this important study.”
“Our collaboration with the Accelerated Cure Project on the OPT-UP clinical research study offers us an extraordinary opportunity to combine complementary expertise and resources to improve patient outcomes,” stated the senior vice president and chief medical officer of EMD Serono, Dr. Thorsten Eickenhorst. “This study underscores our company’s dedication to furthering breakthrough scientific research that can advance treatment options for those living with multiple sclerosis.”
The study will enroll 2,500 patients at about twenty MS locations in the United States Patients will be studied for at least two years and at a maximum of five. The physicians will gather data on treatment outcomes, biological samples, and imaging data, which will be later analyzed by ACP investigators, as well as partner organizations.
“In addition to data from clinical assessments, researchers will also have access to patient-reported outcomes that will be captured online at regular intervals,” explained Ben Greenberg, MD, the director of the Neurosciences Clinical Research Center at the University of Texas Southwestern Medical Center. “I believe that the substantial amount of data and biosamples generated by this study will be enormously valuable in furthering our understanding of MS disease progression.”
Despite the progress made in the area of MS therapeutics, there are still many treatment decisions made “based on trial and error,” as explained by the director of the MS Program at the University of California San Diego and Chair of the OPT-UP Steering Committee, R. Philip Kinkel, MD. “The OPT-UP study objective is to provide data and insights to better match people living with MS with the treatments.”
Since this month, nine clinical trial centers are beginning their participation in OPT-UP, including University of California San Diego, University of Texas Southwestern Medical Center, University of Massachusetts Medical School, Tisch MS Research Center of New York, Johns Hopkins School of Medicine, Ohio State University Medical Center, the Shepherd Center in Atlanta, University of Colorado School of Medicine, and Stanford University School of Medicine.