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

NCT06675955 | Recruiting Phase 3

• 2 other identifiers: MN450532023-507633-21-01
• Study Type: interventional
• Target: 500
• Locations: 4 countries
• Sites: 44

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

Ocrelizumab

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a)

  PROMISnq PFMS-15a includes 15 items that evaluate the impact of MS on a participant's physical functioning, including mobility, upper limb function and activities of daily living. Nine items assess the degree of difficulty in completing physical activities using a 5-point verbal rating scale ranging from 5="without any difficulty" to 1="unable to do". Four items assess physical function limitations, rated from 5="not at all" to 1="cannot do". Two items assess the amount of difficulty associated with selected physical activities, rated from 5="no difficulty" to 1="can't do". Scores are reported as a standardized T-score metric, with higher scores reflecting better physical functioning.

  Baseline up to 5 years

• Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study

  Up to 5 years

Secondary Outcomes (3)

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 5 years

• Number of Participants With Adverse Events (AEs) Leading to Discontinuation

  Up to 5 years

• Number of Participants With Adverse Events of Special Interest (AESIs)

  Up to 5 years

Study Arms (1)

Ocrelizumab

EXPERIMENTAL

Participants will receive ocrelizumab at the currently approved dose of 600 mg, IV infusion or 920 mg, SC injection as per the schedule in the parent study until access to the treatment becomes locally available, unacceptable safety concern, death or withdrawal of consent.

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

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.

Also known as: RO4964913; Ocrevus

Ocrelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (44)

CHU Amiens Hopital Sud

Amiens Cedex1, 80054, France

RECRUITING

CHU de Besancon Hopital Jean Minjoz

Besançon, 25030, France

RECRUITING

Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

RECRUITING

CHU Brest Hopital La Cavale Blanche

Brest, 29609, France

RECRUITING

Hopital neurologique Pierre Wertheimer - CHU Lyon

Bron, 69677, France

RECRUITING

CHU De Caen

Caen, 14033, France

RECRUITING

Hopital Gabriel Montpied CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

WITHDRAWN

CH St Vincent de Paul

Lille, 59000, France

RECRUITING

Hopital Gui de Chauliac

Montpellier, 34295, France

RECRUITING

Hopital Nord Laennec

Nantes, 44093, France

RECRUITING

Hôpital Pasteur

Nice, 06002, France

RECRUITING

GroupeHospitalo-Universitaire Caremeau

Nîmes, 30029, France

RECRUITING

Hopital de Hautepierre

Strasbourg, 67098, France

RECRUITING

NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

Ulm, 89073, Germany

RECRUITING

Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

Westerstede, 26655, Germany

RECRUITING

Deutsche Klinik für Diagnostik

Wiesbaden, 65191, Germany

RECRUITING

Krasnoyarsk State Medical Academy

Krasnoyarsk, Krasnoyarsk Krai, 660022, Russia

RECRUITING

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia

RECRUITING

City Clinical Hospital #24

Moscow, Moscow Oblast, 127015, Russia

RECRUITING

Federal center of brain research and neurotechnologies

Moskva, Moscow Oblast, 117997, Russia

RECRUITING

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, 197110, Russia

RECRUITING

LLC Osnova

Saint Petersburg, Sankt-Peterburg, 197341, Russia

RECRUITING

N.P. Bechtereva Institute of the Human Brain

Saint Petersburg, Sankt-Peterburg, 197376, Russia

RECRUITING

City Hospital #40 of Kurortniy Administrative District

Saint Petersburg, Sankt-Peterburg, 197706, Russia

RECRUITING

SHI Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

RECRUITING

Vertebronevrologiya LLC

Kazan', Tatarstan Republic, 420043, Russia

RECRUITING

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

RECRUITING

Center of Cardiology and Neurology

Kirov, 610007, Russia

RECRUITING

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

Krasnodar, 350086, Russia

RECRUITING

FSBIH Siberian Regional Medical Centre of FMBA of Russia

Novosibirsk, 630007, Russia

RECRUITING

Perm SMA n.a. academ. E.A. Vagner

Perm, 614990, Russia

RECRUITING

5th Cherkasy City Center of Primary Health Care

Cherkasy, 18029, Ukraine

RECRUITING

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

Chernihiv, 14029, Ukraine

RECRUITING

Bukovinsky SMU RMI Chernivtsi RCH

Chernivtsi, 58002, Ukraine

RECRUITING

SI USSRI of Medical and Social Problems of Disabilities of MOHU

Dnipro, 49027, Ukraine

RECRUITING

Regional Clinical Hospital

Ivano-Frankivsk, 76008, Ukraine

RECRUITING

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

Kharkiv, 61068, Ukraine

RECRUITING

Medical Center Dopomoga Plus

Kyiv, 02123, Ukraine

RECRUITING

Medical Center of Private Execution First Private Clinic

Kyiv, 03037, Ukraine

RECRUITING

Volyn Regional Clinical Hospital

Lutsk, 43005, Ukraine

RECRUITING

Lvivska oblasna tsentralna likarnia

Lviv, 79010, Ukraine

RECRUITING

Medical Clinical Research Center of Medical Center LLC Health Clinic

Vinnytsi, 21009, Ukraine

RECRUITING

LCC "Medical center "Unimed"

Zaporizhzhia, 69035, Ukraine

RECRUITING

Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

Zaporizhzhia, 69600, Ukraine

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: MN45053 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

UA (13); FR (13); RU (15); DE (3)