An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment

Last updated: May 8, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Ocrelizumab

Clinical Study ID

NCT06675955
MN45053
2023-507633-21-01
  • Ages > 18
  • All Genders

Study Summary

The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who were on ongoing ocrelizumab treatment on one of the followingparent-studies [Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCEExt., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)] at the time of roll-over and who do not have access to theocrelizumab treatment locally.

  • The first dose of study treatment in this extension study will be received noearlier than 5 months after the last treatment in the parent study.

  • Negative urine pregnancy test within 24 hours to first dose administered on MN45053study treatment in women of childbearing potential.

Exclusion

Exclusion Criteria:

  • Study treatment is commercially marketed in the participant's country for theparticipant specific disease and is reasonably accessible to the participant.

  • Study treatment is available via Post Trial Access Program (PTAP) in theparticipant's country and is accessible to the participant.

  • Permanent discontinuation of study treatment for any reason during the parent studyor during the time between last treatment in the parent study and the first dose ofstudy treatment in this extension study (if applicable).

  • Any condition that, in the opinion of the investigator, would interfere with theinterpretation of participant safety or place the participant at high risk fortreatment-related complications.

  • Concurrent participation in any therapeutic clinical trial (other than the parentstudy).

  • Immunocompromised state

  • Known active malignancy or are being actively monitored for recurrence ofmalignancy.

  • Known presence of other neurological disorders.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Ocrelizumab
Phase: 3
Study Start date:
December 13, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677
    France

    Active - Recruiting

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • Hopital Gui de Chauliac

    Montpellier, 34295
    France

    Active - Recruiting

  • Hôpital Pasteur

    Nice, 06002
    France

    Active - Recruiting

  • GroupeHospitalo-Universitaire Caremeau

    Nimes, 30029
    France

    Active - Recruiting

  • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

    Ulm, 89073
    Germany

    Active - Recruiting

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655
    Germany

    Active - Recruiting

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191
    Germany

    Active - Recruiting

  • SI USSRI of Medical and Social Problems of Disabilities of MOHU

    Dnipro, 49027
    Ukraine

    Active - Recruiting

  • Medical Center Dopomoga Plus

    Kyiv, 02123
    Ukraine

    Active - Recruiting

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