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

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ClinicalTrials.gov Identifier: NCT03599245
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ocrelizumab Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : February 23, 2025
Estimated Study Completion Date : September 23, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ocrelizumab
Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
 Drug: Ocrelizumab
Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599245


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03599245    
Other Study ID Numbers: MN39158
2017-004886-29 ( EudraCT Number )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs