Trial information

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 type: Interventional; Treatment; Randomized; Single Blind; Active; Parallel; Safety/Efficacy study

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:

• adult patients, 18-55 years of age;
• relapsing-remitting multiple sclerosis (MS);
• evidence of recent MS activity;
• at least 2 documented relapses within last 3 years prior to screening, at least one of which occurred within last year prior to screening;
• EDSS at baseline 1.0-6.0.

Exclusion criteria:

• secondary or primary progressive multiple sclerosis at screening;
• disease duration of >15 years, in patients with EDSS <=2.0;
• incompatibility with MRI;
• known presence of other neurologic disorders;
• incompatibility with Avonex use.

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: 8/19/2008

Link to trial result

This trial is being conducted at the following locations:

Belgium

• Edegem
• Sijsele-Damme

Bulgaria

• Sofia

Canada

• Vancouver, BC
• Toronto, ON

Czech Republic

• Ostrava
• Pardubice
• Prague
• Praha
• Teplice

Denmark

• Arhus
• Sonderborg

Finland

• Helsinki
• Turku

France

• Bordeaux
• Caen Cedex 9
• Clermont-Ferrand Cedex1
• Lyon
• Montpellier Cedex
• Nimes

Germany

• Berlin
• Hamburg
• Marburg
• Regensburg
• Siegen
• Tübingen
• Ulm

Italy

• Milan
• Roma

Mexico

• Aguascalientes
• Chihuahua
• Mexico City

Netherlands

• Breda

Poland

• Gdansk
• Lodz
• Lublin
• Warszawa

Romania

• Bucuresti
• Targu Mures

Russian Federation

• Ekaterinburg
• Kazan
• Moscow
• Nizhny Novgorod
• Novosibirsk
• Tyumen

Slovakia

• Banska Bystrica
• Bratislava
• Kosice
• Nitra

Spain

• Barcelona
• Madrid
• Malaga
• Sevilla
• Valencia

Switzerland

• Basel
• Lausanne
• Zurich

Ukraine

• Kharkov
• Kiev
• Propetrovsk
• Vinnytsya

United Kingdom

• Liverpool
• Newcastle upon Tyne
• Nottingham
• Sheffield

United States

• Phoenix, AZ
• Berkeley, CA
• San Francisco, CA
• Salisbury, CT
• Bradenton, FL
• Vero Beach, FL
• Atlanta, GA
• Chicago, IL
• Kansas City, KS
• Baltimore, MD
• Farmington Hills, MI
• Lebanon, NH
• Albuquerque, NM
• New York, NY
• Plainview, NY
• Stony Brook, NY
• Charlotte, NC
• Cleveland, OH
• Columbus, OH
• Tualatin, OR
• Philadelphia, PA
• Nashville, TN
• Houston, TX
• San Antonio, TX
• Burlington, VT
• Charlottesville, VA