CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 220 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Ocrelizumab 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00676715
NCT00676715Phase 2Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted May 13, 2008·Updated Dec 31, 2024

In Brief

A Phase 2 clinical trial evaluating Placebo, Ocrelizumab, and 1 other intervention for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 220 participants across 84 sites in 18 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesBelgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Italy, Mexico, Romania, Russia, Serbia, Slovakia, Spain, Switzerland, Ukraine, United Kingdom, United States
CollaboratorsRoche Pharma AG

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 13, 2008
Enrollment StartJul 17, 2008
Primary CompletionMar 9, 2012
Study CompletionNov 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.1 years ago

Interventions

Placebodrug

Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.

Ocrelizumabdrug

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.

Avonexdrug

Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.