MN39158 - A Long Term Extension Study in Multiple Sclerosis
Research type
Research Study
Full title
A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL
IRAS ID
245998
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-004886-29
Duration of Study in the UK
10 years, 7 months, 7 days
Research summary
Multiple sclerosis (MS) is a chronic disease that requires lifelong treatment in order to reduce frequency of relapse and accumulation of disability. Once a patient is diagnosed with MS, guidelines propose that they be offered lifelong treatment, as there is no evidence to suggest that MS spontaneously remits.
Results of long-term, follow-up studies suggest that exposure to Disease modifying therapy (DMT) for more than 2 years improves outcomes by delaying the time to disability progression. Moreover, a majority of MS patients treated with a DMT, who discontinued therapy, had a return of their baseline disease activity after approximately 2 years
The phase III randomized clinical trials (RCTs) have demonstrated a favorable benefit-risk ratio of ocrelizumab in RMS and PPMS patients. These studies have completed the controlled treatment period and are in the open label extension phase. The ongoing/planned phase IIIb/IV trials (the Parent, P-trial) will further evaluate the effectiveness and safety of ocrelizumab in MS patients.
Based on the favorable profile of ocrelizumab, it is justified to offer ocrelizumab to these patients in order to reduce the frequency of relapses and delay disability progression. Furthermore, Roche had committed to provide treatment for above mentioned patients in the P-trials. Thus, patients who complete the treatment period of the P- trials will be offered participation in this extension study.
Providing patients with the opportunity to prolong treatment with ocrelizumab will provide more information on the long-term safety of ocrelizumab in MS, as well as further collection of tolerability and effectiveness information from patients with long-term exposure.
Analysing the long-term safety, tolerability, and effectiveness of ocrelizumab is of critical importance to eventually help clinicians make informed decisions on therapy for patients.
This is an extension study where participants will be enrolled from P-trials. The total number of participants will depend on the number of participating sites and the number of patients completing the P-trials.
Patients with MS who were previously enrolled in a Roche sponsored ocrelizumab phase IIIb/IV trial, and with a positive benefit risk ratio as determined by a treating neurologist who meet the inclusion/exclusion criteria can be enrolled in this study.
The total length of the study, from screening of the first patient to the end of the study, is expected to be approximately 6 years. For each patient, the treatment period is two years.
The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1.0 date 20-Apr-2018
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0214
Date of REC Opinion
3 Jul 2018
REC opinion
Favourable Opinion