Study to compare Avonex plus a placebo to Ocrelizumab
Multiple Sclerosis Trial Information
A Dose-Finding Study of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis.
Status:
In Canada
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 252.
-
Study Phase: II Study Design / Study Details:
-
Purpose: Treatment
-
Allocation: Randomized
-
Masking: Single Blind Control: Active
-
Assignment: Parallel
-
Endpoints: Safety/Efficacy
-
Study Type: Interventional
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: 02/20/2009
Located In:
Montreal, QC H3A 7B4
Canada
Phone: 973-235-5000 or 800-526-6367
