NCT00676715

A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
DRUG	Ocrelizumab	Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
DRUG	Avonex	Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.

Timeline

• Start date: 2008-07-17
• Primary completion: 2012-03-09
• Completion: 2023-11-08
• First posted: 2008-05-13
• Last updated: 2024-12-31
• Results posted: 2017-05-11

Locations

84 sites across 18 countries: United States, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Italy, Mexico, Romania, Russia, Serbia, Slovakia, Spain, Switzerland, Ukraine, United Kingdom