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OLERO (Open-Label Extension Roll Over)

  • Research type

    Research Study

  • Full title

    A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

  • IRAS ID

    1004763

  • Contact name

    Head of EU Product Development Regulatory

  • Contact email

    global.eudract@roche.com

  • Sponsor organisation

    F. Hoffmann-La Roche Ltd

  • Eudract number

    2021-005746-15

  • Clinicaltrials.gov Identifier

    NCT05269004

  • Research summary

    Participants are being asked to take part in this rollover research study (also known as a clinical trial) because they have either relapsing multiple sclerosis or primary progressive multiple sclerosis and were previously enrolled in studies WA21092, WA21093, or WA25046 (hereinafter called the Parent studies), which will finish at the end of 2022. This study provides continued access to a study drug called ocrelizumab to participants receiving benefit from ocrelizumab treatment in the Parent studies or the option to complete the safety follow-up phase for participants in safety follow-up in a Parent study.

    The purpose of this study is to continue to collect longer-term information on the safety and effectiveness of treatment with ocrelizumab in participants with either relapsing multiple sclerosis or primary progressive multiple sclerosis.
    About 1300 participants from the Parent studies will take part in this study.

  • REC name

    North West - Greater Manchester Central Research Ethics Committee

  • REC reference

    22/NW/0111

  • Date of REC Opinion

    9 Jun 2022

  • REC opinion

    Further Information Favourable Opinion