drugset / Trial / NCT02637856

A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

NCT02637856

Phase 3 Completed 608 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.

Timeline

Start
2016-02-11
Primary completion
2019-05-03
Completion
2019-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody 600 mg Intravenous