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Study Exploring Ocrelizumab in Patients with Relapsing MS is Now Recruiting in US

August 2, 2016

A phase 3 trial that is exploring the effects of Ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS) is now seeking participants in the United States. The Genentech sponsored trial is seeking patients who have previously taken a disease-modifying treatment that did not adequately control their disease activity.

Participants must be between 18 and 55 years old, and both men and women who are not pregnant or breastfeeding can be included in the study. In addition, participants need to have been sick for 10 years or less, and have had no more than two previous rounds of disease modifying treatment that was stopped because it ineffective, the patient began experiencing relapses, or new lesions developed despite treatment.

The study is an open label, non-randomized trial, which means that all patients will receive active treatment with Ocrelizumab. The drug will be given as an initial dose of two 300 mg intravenous infusions separated by 14 days, followed by one 600 mg infusion every 24 weeks for the length of the study, which is expected to run for 96 weeks.

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are reviewing Genentech’s application to approve Ocrelizumab as a treatment for relapsing multiple sclerosis and for primary progressive multiple sclerosis (PPMS). An FDA decision is expected in late December 2016.

The new study will be running at 50 locations across the U.S. and another six locations in Canada. Not all study centers have started to recruit participants, but a full list of sites and their enrollment status is available by visiting the study’s website at clinicaltrials.gov/show/NCT02637856 or by following this link for locations.