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Multiple SclerosisPhase 3OleroMAXNCT06675955

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

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, run by Hoffmann-La Roche at 44 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
44 sitesin 4 countries
Study dates
13 Dec 2024to 31 Dec 2029
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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

Trial locations and contacts

44 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

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

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

44 sites in 4 countries

Russia15 sites, 15 recruiting

  • Vertebronevrologiya LLC

    Kazan', Tatarstan Republic, 420043

    Recruiting

  • Center of Cardiology and Neurology

    Kirov, 610007

    Recruiting

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

    Krasnodar, 350086

    Recruiting

  • Krasnoyarsk State Medical Academy

    Krasnoyarsk, Krasnoyarsk Krai, 660022

    Recruiting

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

    Krasnoyarsk, Krasnoyarsk Krai, 660037

    Recruiting

  • City Clinical Hospital #24

    Moscow, Moscow Oblast, 127015

    Recruiting

  • Federal center of brain research and neurotechnologies

    Moskva, Moscow Oblast, 117997

    Recruiting

  • FSBIH Siberian Regional Medical Centre of FMBA of Russia

    Novosibirsk, 630007

    Recruiting

  • Perm SMA n.a. academ. E.A. Vagner

    Perm, 614990

    Recruiting

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110

    Recruiting

  • LLC Osnova

    Saint Petersburg, Sankt-Peterburg, 197341

    Recruiting

  • N.P. Bechtereva Institute of the Human Brain

    Saint Petersburg, Sankt-Peterburg, 197376

    Recruiting

  • City Hospital #40 of Kurortniy Administrative District

    Saint Petersburg, Sankt-Peterburg, 197706

    Recruiting

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063

    Recruiting

  • SHI Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, Sverdlovsk Oblast, 620102

    Recruiting

Other trials in Russia

France13 sites, 12 recruiting

  • CHU Amiens Hopital Sud

    Amiens Cedex1, 80054

    Recruiting

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, 25030

    Recruiting

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076

    Recruiting

  • CHU Brest Hopital La Cavale Blanche

    Brest, 29609

    Recruiting

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677

    Recruiting

  • CHU De Caen

    Caen, 14033

    Recruiting

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003

    Withdrawn

  • CH St Vincent de Paul

    Lille, 59000

    Recruiting

  • Hopital Gui de Chauliac

    Montpellier, 34295

    Recruiting

  • Hopital Nord Laennec

    Nantes, 44093

    Recruiting

  • Hôpital Pasteur

    Nice, 06002

    Recruiting

  • GroupeHospitalo-Universitaire Caremeau

    Nîmes, 30029

    Recruiting

  • Hopital de Hautepierre

    Strasbourg, 67098

    Recruiting

Other trials in France

Ukraine13 sites, 13 recruiting

  • 5th Cherkasy City Center of Primary Health Care

    Cherkasy, 18029

    Recruiting

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

    Chernihiv, 14029

    Recruiting

  • Bukovinsky SMU RMI Chernivtsi RCH

    Chernivtsi, 58002

    Recruiting

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

    Dnipro, 49027

    Recruiting

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008

    Recruiting

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

    Kharkiv, 61068

    Recruiting

  • Medical Center Dopomoga Plus

    Kyiv, 02123

    Recruiting

  • Medical Center of Private Execution First Private Clinic

    Kyiv, 03037

    Recruiting

  • Volyn Regional Clinical Hospital

    Lutsk, 43005

    Recruiting

  • Lvivska oblasna tsentralna likarnia

    Lviv, 79010

    Recruiting

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsi, 21009

    Recruiting

  • LCC "Medical center "Unimed"

    Zaporizhzhya, 69035

    Recruiting

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

    Zaporizhzhya, 69600

    Recruiting

Other trials in Ukraine

Germany3 sites, 3 recruiting

  • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

    Ulm, 89073

    Recruiting

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655

    Recruiting

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Being tested
Ocrelizumab
Keywords
Ocrelizumab
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    Also called RO4964913; Ocrevus

    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.

Study groups in NCT06675955
Study groupRoleWhat they receive
OcrelizumabExperimentalParticipants 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.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to 5 years

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

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Number of Participants With Serious Adverse Events (SAEs)

    Measured: Up to 5 years

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

    Measured: Up to 5 years

  3. Number of Participants With Adverse Events of Special Interest (AESIs)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2024
  2. Study start13 Dec 2024
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06675955
Sponsor's protocol ID
MN45053
Other IDs
2023-507633-21-01, 2023
Acronym
OleroMAX
Status last verified
Feb 2026
First submitted
4 Nov 2024
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

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