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NCT Number: NCT03599245

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Churruca Visca, Buenos Aires, Argentina

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About this study

This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed Informed Consent Form
  • Able to comply with the study protocol, in the investigator's judgment
  • Completed the treatment period of Roche sponsored ocrelizumab P-trials

Exclusion criteria

  • Hypersensitivity to ocrelizumab or to any of its excipients.
  • Participantss in a severely immunocompromised state until the condition resolves.
  • Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
  • Existence of a contra-indication as per SmPC
  • Prohibited concomitant medication as specified in protocol
  • Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study

Treatment and study plan

Ocrelizumab

Drug

Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.

Primary outcomes

  1. Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks

    Time frame: Up to 2 Years

  2. Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment

    Time frame: Up to 2 years

  3. Percentage of participants who have improved, stable or worsened disability compared with baseline

    Time frame: Up to 2 years

    Improved, stable or worsened disability is measured by expanded disability status scale (EDSS) (annually/by epoch and over duration of the study) Stable EDSS is defined as EDSS change +/- 0.5. Worsening is > 0.5 increase of EDSS, Improvement is >0.5 decrease of EDSS

  4. Mean change from inclusion in parent study in EDSS score over the course of the treatment

    Time frame: Up to 2 years

  5. Time to 20% increase in timed 25-foot walk test (T25FWT)

    Time frame: Up to 2 years

    Time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end treatment

Secondary outcomes

  1. Time to first protocol-defined event of disease activity

    Time frame: Up to 2 Years

  2. Time to first relapse

    Time frame: Up to 2 Years

  3. Annualized relapse rate

    Time frame: Up to 2 Years

  4. Percentage of participants relapse free, yearly and over the course of the treatment

    Time frame: Up to 2 Years

  5. Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment

    Time frame: Up to 2 Years

    Disease activity is defined as at least one the following events: protocol-defined relapse; 24 weeks CDP based on increases in EDSS; a T1 Gadolinium (Gd)-enhanced lesion; or a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI).

  6. Percentage of participants with no evidence of progression (NEP)

    Time frame: Up to 2 Years

    NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20% increase in timed T25FWT; 20% increase in timed 9HPT yearly and over the course of the treatment

  7. Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)

    Time frame: Up to 2 Years

    NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion yearly and over the course of the treatment

  8. Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)

    Time frame: Up to 2 Years

  9. Total number of T1 Gd-enhancing lesions as detected by brain MRI over time

    Time frame: Up to 2 Years

  10. Total number of new and/or enlarging T2 lesion as detected by brain MRI over time

    Time frame: Up to 2 Years

  11. Change in total T1 hypointense lesion volume over time

    Time frame: Up to 2 Years

  12. Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time

    Time frame: Up to 2 Years

  13. Change in brain volume (grey and white matter) as detected by brain MRI over time

    Time frame: Up to 2 Years

  14. Presence and evolution of leptomeningeal follicles as detected by MRI

    Time frame: Up to 2 Years

  15. Time to treatment discontinuation/switch

    Time frame: Up to 2 Years

  16. Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])

    Time frame: Up to 2 Years

  17. Participant reported outcomes: SymptoMScreen Score

    Time frame: Up to 2 Years

  18. Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)

    Time frame: Up to 2 Years

  19. Percentage of Participants with Adverse Events

    Time frame: Up to 2 Years

  20. Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2018
Registry last updated
Nov 12, 2025

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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