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RECRUITINGPhase 3INTERVENTIONAL

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

An Open-label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-trial Access Program

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\] at the time of roll-over and who do not have access to the ocrelizumab treatment locally - The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study - Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential Who Should NOT Join This Trial: - Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant - Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant - Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable) - Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications - Concurrent participation in any therapeutic clinical trial (other than the parent study) - Immunocompromised state - Known active malignancy or are being actively monitored for recurrence of malignancy - Known presence of other neurological disorders Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\] at the time of roll-over and who do not have access to the ocrelizumab treatment locally * The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study * Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential Exclusion Criteria: * Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant * Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant * Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable) * Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications * Concurrent participation in any therapeutic clinical trial (other than the parent study) * Immunocompromised state * Known active malignancy or are being actively monitored for recurrence of malignancy * Known presence of other neurological disorders

Treatments Being Tested

DRUG

Ocrelizumab

Ocrelizumab will be administered at the approved dose of 600 mg, IV infusion or 920 mg, SC injection, according to the regimen in the parent study.

Locations (20)

CHU Amiens Hopital Sud
Amiens Cedex1, France
CHU de Besancon Hopital Jean Minjoz
Besançon, France
Groupe Hospitalier Pellegrin
Bordeaux, France
CHU Brest Hopital La Cavale Blanche
Brest, France
Hopital neurologique Pierre Wertheimer - CHU Lyon
Bron, France
CHU De Caen
Caen, France
Hopital Gabriel Montpied CHU de Clermont-Ferrand
Clermont-Ferrand, France
CH St Vincent de Paul
Lille, France
Hopital Gui de Chauliac
Montpellier, France
Hopital Nord Laennec
Nantes, France
Hôpital Pasteur
Nice, France
GroupeHospitalo-Universitaire Caremeau
Nîmes, France
Hopital de Hautepierre
Strasbourg, France
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
Ulm, Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede, Germany
Deutsche Klinik für Diagnostik
Wiesbaden, Germany
Krasnoyarsk State Medical Academy
Krasnoyarsk, Krasnoyarsk Krai, Russia
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Krasnoyarsk Krai, Russia
City Clinical Hospital #24
Moscow, Moscow Oblast, Russia
Federal center of brain research and neurotechnologies
Moskva, Moscow Oblast, Russia