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NCT Number: NCT06675955

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens Hopital Sud, Amiens Cedex1, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: RO4964913; Ocrevus

Primary outcomes

  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)

    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.

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

    Time frame: Up to 5 years

Secondary outcomes

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

    Time frame: Up to 5 years

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

    Time frame: Up to 5 years

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

    Time frame: Up to 5 years

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: OleroMAX

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 6, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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