MedTrace Logo

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

NCT00676715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-12-31

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-17
Primary Completion
2012-03-09
Completion
2023-11-08

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Mexico
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • Switzerland
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676715 on ClinicalTrials.gov