Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were not helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society.
The trial is an open-label study, meaning that all participants will receive Ocrevus. The treatment will be given in two 300 mg infusions, 14 days apart, followed by a single 600 mg infusion every 24 weeks. A maximum of four doses over 96 weeks will be given.
About 600 patients ages 18 to 55, who have been sick for 10 years or less, will be eligible for the study if they have undergone up to two previous treatment rounds with other therapies, each lasting for at least six months. The most recent treatment course had to have been stopped for a lack of treatment effects.
Pregnant or breastfeeding women, people in need of chronic treatment with corticosteroids or immunosuppressants, and patients who have certain infections, including hepatitis B or C, HIV, syphilis, or tuberculosis, will not be eligible for participation.
The study, which will be run at 80 study centers across the U.S., will mainly focus on measuring the percent of participants who do not experience a relapse, new disease activity on magnetic resonance imaging (MRI) brain scans, or disability progression over a 96-week period.
Researchers will also analyze how many patients experience disease activity in the form of relapse, new brain lesions, or disability progression after 24 and 48 weeks, and measure the time period before patients experience any of these events.
For more information or to enroll in the trial, patients or their physicians can contact the study’s staff by calling 1-888-662-6728, or by emailing [email protected]. Patients and doctors will asked to use the trial reference ID number: MN30035. A full list of study sites is available below.
Ocrevus is an antibody treatment that blocks a molecule called CD20 on the surface of immune B-cells. Researchers believe that these cells are involved in mediating MS disease processes and nerve damage.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?