Ocrelizumab in adults with Primary Progressive Multiple Sclerosis
Research type
Research Study
Full title
A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis
IRAS ID
60336
Contact name
Carolyn Young
Sponsor organisation
F. Hoffman-La Roche,
Eudract number
2010-020338-25
Clinicaltrials.gov Identifier
Research summary
Primary Progressive Multiple Sclerosis (PPMS) is a relatively rare form of MS, accounting for approximately 10-15% of all people with MS. No treatment has been demonstrated to significantly slow the progression of disability in patients with PPMS, including therapies approved for the treatment of relapsing forms of MS.This study is a phase III, multicentre, randomised, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with (PPMS).Ocrelizumab is an investigational drug being studied by F. Hoffmann-La Roche for treating PPMS. Ocrelizumab is a drug which destroys a type of white blood cell called a B-cell, which is believed to play a role in some of the symptoms of MS. It is similar to a drug called rituximab which is already approved for use as a treatment in patients with Non-Hodgkin's Lymphoma and Rheumatoid Arthritis. Ocrelizumab has a slightly different structure to rituximab and it is thought that this may make it less likely to cause certain side effects.The purpose of this research trial is to answer the following questions:How well does ocrelizumab stabilise, or potentially improve the signs and symptoms of PPMS compared to no active treatment?How safe is treatment with ocrelizumab and how well is ocrelizumab tolerated?How does ocrelizumab affect the body, and how well does the body break down ocrelizumab? Is there any way we can predict, with laboratory information or brain Magnetic Resonance Imaging (MRI) scans, how ocrelizumab will help in the clinical course of this disease?A total of 630 participants will be enrolled and assigned (2:1 randomisation) to either an ocrelizumab arm or a placebo arm, stratified by age and region.The participant study duration is expected to range between 3 and 5.5 years.This study involves procedures including: physical exams, bloods, urine samples, vital signs, ECGs, questionnaires, MRI scans, telephone interviews.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
10/H1005/81
Date of REC Opinion
29 Dec 2010
REC opinion
Further Information Favourable Opinion