MN39889 - Multiple Sclerosis NIS RWD Study Assessing Ocrelizumab
Research type
Research Study
Full title
A Multiple Non-Interventional Study to Assess the Real-World Effectiveness of Ocrelizumab in Patients with Relapsing or Primary Progressive Multiple Sclerosis. The MUSICALE Study
IRAS ID
252874
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Clinicaltrials.gov Identifier
ClinicalTrials.gov Identifier , NCT03593590
Duration of Study in the UK
6 years, 3 months, 11 days
Research summary
Our current knowledge of Ocrelizumab is from clinical trials, involving selected populations that were managed according to strict protocols. This information may not be fully generalisable to routine clinical practice and currently there is no data describing use of ocrelizumab in a real-world setting.
The purpose of this observational study (MUSICALE Study) is to see how treatment with Ocrelizumab works in “real life” in the context of routine medical practice. The study will also provide additional safety information about how well ocrelizumab is tolerated by patients prescribed in every day medical practice.Only patients with relapsing multiple sclerosis (RMS) whose doctor has decided to treat their RMS with Ocrelizumab according to routine practice, will be invited to participate in the study. Patients will not be eligible for the study if they have previously been treated with Ocrelizumab.
Patients that provide their written consent, will be asked to complete several questionnaires before each Ocrelizumab treatment and their routine medical health information will be collected over a period of 4 years. In addition, patients will be observed for a further 6 month to collect safety information.
1000 MS patients will be enrolled globally, and approximately 120 RMS patients will be enrolled from 15 UK hospitals
The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1.0 and date: 25-Jan-19
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0058
Date of REC Opinion
25 Feb 2019
REC opinion
Favourable Opinion