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Trial record 1 of 1 for:    ML42071 | Multiple Sclerosis
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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.

Tracking Information
First Submitted Date  ICMJE May 1, 2020
First Posted Date  ICMJE May 6, 2020
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE July 30, 2020
Estimated Primary Completion Date June 8, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • 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 Confirmed Disability Progression (CDP) event at 24 weeks; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)
  • Change in Neurofilament Light Chain (NfL) Levels in Cerebrospinal Fluid (CSF) in the Optional Substudy [ Time Frame: Week 48 ]
    This outcome measure will assess biomarkers of neuronal damage in CSF during treatment with ocrelizumab. NfL is measured in picograms/milliliter.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 [ Time Frame: Week 48 ]
  • 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
  • Annualized relapse rate at week 48 [ Time Frame: Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • Time to onset of confirmed disability progression at Week 24 (CDP24) and at Week 48 (CDP48) [ Time Frame: At Week 24 and Week 48 ]
  • Time to protocol-defined event [ Time Frame: 96 Weeks ]
    A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a Confirmed Disability Progression (CDP) event at 24 weeks; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI
  • Annualized relapse rate at week 48 [ Time Frame: At Week 48 ]
  • Time to onset of first relapse [ Time Frame: 96 Weeks ]
  • Time to onset of first T1 Gd-enhanced lesion [ Time Frame: 96 Weeks ]
  • Time to onset of first new and/or enlarging T2 lesion [ Time Frame: 96 Weeks ]
  • Total number of T1 Gd-enhanced lesions detected by brain MRI [ Time Frame: 96 Weeks ]
  • Total number of new and/or enlarging T2 lesions detected by brain MRI [ Time Frame: 96 Weeks ]
  • Change in Expanded Disability Status Scale (EDSS) Score [ Time Frame: 96 Weeks ]
  • Change in 9 Hole Peg Test (9HPT) Score [ Time Frame: 96 Weeks ]
  • Change in 25-Foot Timed Walk (T25FTW) [ Time Frame: 96 Weeks ]
  • Change in Serum NfL Level [ Time Frame: 96 Weeks ]
  • Proportion of Participants with Adverse Events (AEs) [ Time Frame: 96 Weeks ]
  • Proportion of Participants with AEs in the Optional Substudy [ Time Frame: 96 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Ocrelizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 9, 2024
Estimated Primary Completion Date June 8, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Kenya,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04377555
Other Study ID Numbers  ICMJE ML42071
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP