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

February 16, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens Cedex1, France, 80054
        • Recruiting
        • CHU Amiens Hopital Sud
      • Besançon, France, 25030
        • Recruiting
        • CHU de Besancon Hopital Jean Minjoz
      • Bordeaux, France, 33076
        • Recruiting
        • Groupe hospitalier Pellegrin
      • Brest, France, 29609
        • Recruiting
        • CHU Brest Hopital la Cavale Blanche
      • Bron, France, 69677
        • Recruiting
        • Hopital neurologique Pierre Wertheimer - CHU Lyon
      • Caen, France, 14033
        • Recruiting
        • CHU De Caen
      • Clermont-Ferrand, France, 63003
        • Withdrawn
        • Hopital Gabriel Montpied CHU de Clermont-Ferrand
      • Lille, France, 59000
        • Recruiting
        • CH St Vincent de Paul
      • Montpellier, France, 34295
        • Recruiting
        • Hôpital Gui de Chauliac
      • Nantes, France, 44093
        • Recruiting
        • Hopital Nord Laennec
      • Nice, France, 06002
        • Recruiting
        • Hopital Pasteur
      • Nîmes, France, 30029
        • Recruiting
        • GroupeHospitalo-Universitaire Caremeau
      • Strasbourg, France, 67098
        • Recruiting
        • Hôpital de Hautepierre
  • Germany
      • Ulm, Germany, 89073
        • Recruiting
        • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
      • Westerstede, Germany, 26655
        • Recruiting
        • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
      • Wiesbaden, Germany, 65191
        • Recruiting
        • Deutsche Klinik für Diagnostik
  • Russia
      • Kirov, Russia, 610007
        • Recruiting
        • Center of Cardiology and Neurology
      • Krasnodar, Russia, 350086
        • Recruiting
        • Regional clinical hospital named after prof. S.V. Ochapovsky
      • Novosibirsk, Russia, 630007
        • Recruiting
        • FSBIH Siberian Regional Medical Centre of FMBA of Russia
      • Perm, Russia, 614990
        • Recruiting
        • Perm SMA n.a. academ. E.A. Vagner
    • Krasnoyarsk Krai
      • Krasnoyarsk, Krasnoyarsk Krai, Russia, 660037
        • Recruiting
        • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
      • Krasnoyarsk, Krasnoyarsk Krai, Russia, 660022
        • Recruiting
        • Krasnoyarsk State Medical Academy
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 127015
        • Recruiting
        • City Clinical Hospital #24
      • Moskva, Moscow Oblast, Russia, 117997
        • Recruiting
        • Federal center of brain research and neurotechnologies
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197706
        • Recruiting
        • City Hospital #40 of Kurortniy Administrative District
      • Saint Petersburg, Sankt-Peterburg, Russia, 197341
        • Recruiting
        • LLC Osnova
      • Saint Petersburg, Sankt-Peterburg, Russia, 197376
        • Recruiting
        • N.P. Bechtereva Institute of the Human Brain
      • Saint Petersburg, Sankt-Peterburg, Russia, 197110
        • Recruiting
        • National Center of Social Significant Disease
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620102
        • Recruiting
        • SHI Sverdlovsk Regional Clinical Hospital #1
    • Tatarstan Republic
      • Kazan', Tatarstan Republic, Russia, 420043
        • Recruiting
        • Vertebronevrologiya LLC
    • Ulyanovsk Oblast
      • Ulyanovsk, Ulyanovsk Oblast, Russia, 432063
        • Recruiting
        • Ulyanovsk Regional Clinical Hospital
  • Ukraine
      • Cherkasy, Ukraine, 18029
        • Recruiting
        • 5th Cherkasy City Center of Primary Health Care
      • Chernihiv, Ukraine, 14029
        • Recruiting
        • Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?
      • Chernivtsi, Ukraine, 58002
        • Recruiting
        • Bukovinsky SMU RMI Chernivtsi RCH
      • Dnipro, Ukraine, 49027
        • Recruiting
        • SI USSRI of Medical and Social Problems of Disabilities of MOHU
      • Ivano-Frankivsk, Ukraine, 76008
        • Recruiting
        • Regional Clinical Hospital
      • Kharkiv, Ukraine, 61068
        • Recruiting
        • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU
      • Kyiv, Ukraine, 02123
        • Recruiting
        • Medical Center Dopomoga Plus
      • Kyiv, Ukraine, 03037
        • Recruiting
        • Medical Center of Private Execution First Private Clinic
      • Lutsk, Ukraine, 43005
        • Recruiting
        • Volyn Regional Clinical Hospital
      • Lviv, Ukraine, 79010
        • Recruiting
        • Lvivska oblasna tsentralna likarnia
      • Vinnytsi, Ukraine, 21009
        • Recruiting
        • Medical Clinical Research Center of Medical Center LLC Health Clinic
      • Zaporizhzhia, Ukraine, 69035
        • Recruiting
        • LCC "Medical center "Unimed"
      • Zaporizhzhia, Ukraine, 69600
        • Recruiting
        • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ocrelizumab
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
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.
Other Names:
  • RO4964913; Ocrevus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study
Time Frame: Up to 5 years
Up to 5 years
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)
Time Frame: Baseline up to 5 years
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to 5 years
Up to 5 years
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
Time Frame: Up to 5 years
Up to 5 years
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MN45053
  • 2023-507633-21-01 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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