Ocrevus (ocrelizumab), a recently approved therapy for relapsing and primary progressive multiple sclerosis (MS), is now on the U.S. market, but research into its use is far from over.
Multiple Sclerosis News Today took a closer look at the goals of these trials, and spoke to Dr. Hideki Garren — Genentech’s Group Medical Director of Ocrelizumab — about new insights they might offer.
The trials have similar age limitations as earlier Phase 3 studies. Only people older than 18 or younger than 55 will be able to participate.
All currently running trials stick to the infusion procedure listed on Ocrevus’ label. The first course of treatment involves two infusions — two weeks apart — in which the 600 mg dose is split in two. All remaining infusions will be administered as a single 600 mg infusion at six-month intervals.
Ocrevus in previous treatment failures
Among the largest of the ongoing trials are two nearly identical Phase 3 studies. They are looking at the safety and effectiveness of Ocrevus among patients who failed to respond to an earlier disease-modifying treatment.
Those conducting the studies — one taking place in North America (NCT02637856) and a second recruiting patients across Europe and Australia (NCT02861014) — plan to enroll 600 relapsing MS patients each. Since earlier disease-modifying treatments are approved only for relapsing-remitting MS, no progressive MS patients are eligible for these studies.
In the two trials exploring Ocrevus’ effectiveness in patients who failed to respond to a disease-modifying treatment, participants will receive a maximum of four treatment rounds.
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