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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



  • Contact name

    Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR

  • Contact email

  • Sponsor organisation

    F Hoffmann-La Roche Ltd

  • Identifier 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


  • Date of REC Opinion

    25 Feb 2019

  • REC opinion

    Favourable Opinion