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

Last updated: November 14, 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), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINAII-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 participants 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 premature discontinuation of study treatment for any reason during theparent study or during the time between last treatment in the parent study and thefirst dose of study 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

  • CHU Amiens Hopital Sud

    Amiens Cedex1, 80054
    France

    Active - Recruiting

  • CHU de Besancon Hopital Jean Minjoz

    Besançon 3033123, 25030
    France

    Active - Recruiting

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • Groupe Hospitalier Pellegrin

    Bordeaux 3031582, 33076
    France

    Active - Recruiting

  • CHU Brest Hopital La Cavale Blanche

    Brest 3030300, 29609
    France

    Active - Recruiting

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677
    France

    Site Not Available

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron 3029931, 69677
    France

    Active - Recruiting

  • CHU De Caen

    Caen, 14033
    France

    Site Not Available

  • CHU De Caen

    Caen 3029241, 14033
    France

    Active - Recruiting

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand 3024635, 63003
    France

    Active - Recruiting

  • CH St Vincent de Paul

    Lille 2998324, 59000
    France

    Active - Recruiting

  • Hopital Gui de Chauliac

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Gui de Chauliac

    Montpellier 2992166, 34295
    France

    Active - Recruiting

  • Hôpital Pasteur

    Nice, 06002
    France

    Site Not Available

  • Hôpital Pasteur

    Nice 2990440, 06002
    France

    Active - Recruiting

  • GroupeHospitalo-Universitaire Caremeau

    Nimes, 30029
    France

    Site Not Available

  • GroupeHospitalo-Universitaire Caremeau

    Nîmes 2990363, 30029
    France

    Active - Recruiting

  • Hopital de Hautepierre

    Strasbourg 2973783, 67098
    France

    Active - Recruiting

  • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

    Ulm, 89073
    Germany

    Site Not Available

  • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

    Ulm 2820256, 89073
    Germany

    Active - Recruiting

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655
    Germany

    Site Not Available

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede 2810188, 26655
    Germany

    Active - Recruiting

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191
    Germany

    Site Not Available

  • Deutsche Klinik für Diagnostik

    Wiesbaden 2809346, 65191
    Germany

    Active - Recruiting

  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

    Krasnoyarsk 1502026, Krasnoyarsk Krai 1502020 660037
    Russia

    Active - Recruiting

  • City Clinical Hospital #24

    Moscow, Moscow Oblast 524925 127015
    Russia

    Active - Recruiting

  • City Hospital #40 of Kurortniy Administrative District

    Saint Petersburg 498817, Sankt-Peterburg 536203 197706
    Russia

    Active - Recruiting

  • Vertebronevrologiya LLC

    Kazan' 551487, Tatarstan Republic 484048 420043
    Russia

    Active - Recruiting

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk 479123, Ulyanovsk Oblast 479119 432063
    Russia

    Active - Recruiting

  • Center of Cardiology and Neurology

    Kirov 548408, 610007
    Russia

    Active - Recruiting

  • Regional clinical hospital named after prof. S.V. Ochapovsky

    Krasnodar 542420, 350086
    Russia

    Active - Recruiting

  • FSBIH Siberian Regional Medical Centre of FMBA of Russia

    Novosibirsk 1496747, 630007
    Russia

    Active - Recruiting

  • 5th Cherkasy City Center of Primary Health Care

    Cherkasy 710791, 18029
    Ukraine

    Active - Recruiting

  • Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?

    Chernihiv 710735, 14029
    Ukraine

    Active - Recruiting

  • Bukovinsky SMU RMI Chernivtsi RCH

    Chernivtsi 710719, 58002
    Ukraine

    Active - Recruiting

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

    Dnipro, 49027
    Ukraine

    Site Not Available

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

    Dnipro 709930, 49027
    Ukraine

    Active - Recruiting

  • Regional Clinical Hospital

    Ivano-Frankivsk 707471, 76008
    Ukraine

    Active - Recruiting

  • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU

    Kharkiv 706483, 61068
    Ukraine

    Active - Recruiting

  • Medical Center Dopomoga Plus

    Kyiv, 02123
    Ukraine

    Site Not Available

  • Medical Center Dopomoga Plus

    Kyiv 703448, 02123
    Ukraine

    Active - Recruiting

  • Medical Center of Private Execution First Private Clinic

    Kyiv 703448, 03037
    Ukraine

    Active - Recruiting

  • Lvivska oblasna tsentralna likarnia

    Lviv 702550, 79010
    Ukraine

    Active - Recruiting

  • LCC "Medical center "Unimed"

    Zaporizhzhia 707652, 69035
    Ukraine

    Active - Recruiting

  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

    Zaporizhzhia 707652, 69600
    Ukraine

    Active - Recruiting

  • LCC "Medical center "Unimed"

    Zaporizhzhia 9112866, 69035
    Ukraine

    Site Not Available

  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

    Zaporizhzhia 9112866, 69600
    Ukraine

    Active - Recruiting

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