Trial Information

Summary: A Dose-Finding Study of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis.

Status: Recruiting

Protocol Number: WA21493

Sponsor: Hoffmann-La Roche; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, placebo and active-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 relapsing-remitting multiple sclerosis

Brief Summary: This study will evaluate the efficacy and safety of two dose regimens of ocrelizumab, compared to placebo and Avonex, on brain MRI lesions in patients with relapsing-remitting multiple sclerosis. Patients will be randomized to one of 4 treatment groups; group 1 will receive ocrelizumab 1000mg as a dual infusion in cycle 1, followed by single infusions of 1000mg in cycles 2-4; group 2 will receive ocrelizumab 300mg dual infusions in cycle 1, followed by single infusions of 600mg in cycles 2-4; group 3 will receive placebo infusions in cycle 1 and group 4 will receive Avonex 30 micrograms i.m. weekly in cycle 1; groups 3 and 4 will be offered ocrelizumab treatment in cycles 2-4. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. In the US this trial is sponsored/managed by Genentech. Target sample size is 200.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Single Blind
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Multiple Sclerosis, Relapsing-Remitting

Intervention Type: Drug

Intervention Name: ocrelizumab

Primary Outcome: 1. Total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain. Time frame: Weeks 12, 16, 20 and 24

Key Secondary Outcomes: 1. Annualized protocol defined relapse rate Time frame: Week 24 2. Total number of gadolinium-enhancing T1 lesions, and total number of new and/or enlarging gadolinium-enhancing T1 lesions, observed on MRI scans of the brain. Time frame: Weeks 4, 8, 12, 16, 20 and 24. 3. Change in total volume of T2 lesions on MRI scans of the brain Time frame: From baseline to week 24 4. Adverse events, laboratory parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 55 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2008

Trial Registration Date: 06/24/2008

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:25:09 PM