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Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab.

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ClinicalTrials.gov Identifier: NCT04377555
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing Drug: Ocrelizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : June 8, 2023
Estimated Study Completion Date : May 9, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: All Participants
Main study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72.
Drug: Ocrelizumab
Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.




Primary Outcome Measures :
  1. Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment [ Time Frame: 48 Weeks ]
    A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)


Secondary Outcome Measures :
  1. Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 [ Time Frame: Week 48 ]
  2. Time to protocol-defined event [ Time Frame: Week 48 ]
    A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI

  3. Annualized relapse rate at week 48 [ Time Frame: Week 48 ]


Information from the National Library of Medicine

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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:

  • Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
  • Participants who self-identify as Black or African American or Hispanic/Latino American
  • Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
  • Neurologically stable for at least 30 days prior to randomization and baseline assessments

Exclusion Criteria:

  • Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)
  • Primary Progressive Multiple Sclerosis (PPMS)
  • Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure
  • Infection Related
  • Cancer Related
  • Pregnant or lactating, or intending to become pregnant during the study
  • Other Medical Conditions
  • Known presence or history of other neurologic disorders
  • Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab
  • Laboratory: abnormalities or findings at screening

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): NCT04377555


Contacts
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Contact: Reference Study ID Number: ML42071 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) Global-Roche-Genentech-Trials@gene.com

Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04377555    
Other Study ID Numbers: ML42071
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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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