A Phase 3 clinical trial exploring Ocrevus (ocrelizumab) in patients with relapsing-remitting multiple sclerosis (RRMS) is now recruiting participants. The trial, sponsored by Genentech (NCT02637856), 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 Ocrevus. 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.
Investigators’ main purpose is to evaluate both the efficacy and safety of the treatment, determined by the percentage of participants who do not experience relapses, new brain lesions measured by magnetic resonance imaging (MRI), or disability progression after 96 weeks.
The study will also measure the fraction of patients not experiencing such negative outcomes at other time points during the trial, and will explore how long it takes before patients have relapses, new lesions, or disability progression, as well as register the number of new brain lesions that might develop during the trial.
In two Phase 3 double-blind clinical studies in 1,656 people with relapsing forms of MS, called OPERA I and OPERA II, Ocrevus (ocrelizumab, 600 mg administered by intravenous infusion every 24 weeks) was compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week). Ocrevus was shown to significantly reduce the annualized relapse rate – the primary endpoint of both studies – by nearly 50 percent compared with interferon beta-1a over a two-year period. Additionally, the treatment met the study’s secondary endpoints, significantly delaying confirmed disability progression (loss of physical abilities, as measured by the Expanded Disability Status Scale, or EDSS) by approximately 40 percent sustained for both 12 and 24 weeks compared with interferon beta-1a in a pooled analyses of the two studies.
Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are reviewing Genentech’s application to approve Ocrevus as a treatment for relapsing multiple sclerosis and for primary progressive multiple sclerosis (PPMS). An FDA decision is expected in late December 2016, the company announced in a June press release.
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.
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