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

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ClinicalTrials.gov Identifier: NCT04377555
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is an open-label, multicenter study that includes a main study for all participants enrolled and an optional cerebrospinal fluid (CSF) sub-study. Self-identified African American (AA) and Hispanic or Latin American (HA) participants with a diagnosis of relapsing multiple sclerosis (RMS) will be enrolled. The treating neurologist must make an independent medical assessment and decision to initiate ocrelizumab treatment per label (USPI) as the most appropriate standard of care treatment for the participant. 150 participants will be enrolled in the main study (75 AA and 75 HA) and 50 participants will be enrolled in the CSF sub-study (25 AA and 25 HA). Participants will be assessed for disease activity and biomarkers of neuronal damage at baseline and during treatment with ocrelizumab.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter 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 : September 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: All Participants
Participants in the main study will be evaluated at baseline, monitored, and followed for a 1-year period with the option to continue in the study for a second year of treatment.
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.

Experimental: CSF-Substudy Participants
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 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)

  2. 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.


Secondary Outcome Measures :
  1. Time to onset of confirmed disability progression at Week 24 (CDP24) and at Week 48 (CDP48) [ Time Frame: At Week 24 and Week 48 ]
  2. 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

  3. Annualized relapse rate at week 48 [ Time Frame: At Week 48 ]
  4. Time to onset of first relapse [ Time Frame: 96 Weeks ]
  5. Time to onset of first T1 Gd-enhanced lesion [ Time Frame: 96 Weeks ]
  6. Time to onset of first new and/or enlarging T2 lesion [ Time Frame: 96 Weeks ]
  7. Total number of T1 Gd-enhanced lesions detected by brain MRI [ Time Frame: 96 Weeks ]
  8. Total number of new and/or enlarging T2 lesions detected by brain MRI [ Time Frame: 96 Weeks ]
  9. Change in Expanded Disability Status Scale (EDSS) Score [ Time Frame: 96 Weeks ]
  10. Change in 9 Hole Peg Test (9HPT) Score [ Time Frame: 96 Weeks ]
  11. Change in 25-Foot Timed Walk (T25FTW) [ Time Frame: 96 Weeks ]
  12. Change in Serum NfL Level [ Time Frame: 96 Weeks ]
  13. Proportion of Participants with Adverse Events (AEs) [ Time Frame: 96 Weeks ]
  14. Proportion of Participants with AEs in the Optional Substudy [ Time Frame: 96 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 African American or Hispanic/Latino American
  • Treatment-naïve or initiating first switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethylfumarate (DMF); or siponimod; or fingolimod
  • Disease duration from the onset of MS symptoms: less than 15 years in participants with an EDSS >5.0 at screening
  • At least one clinically documented episode (for naïve participants) or suboptimal response or intolerance to prior DMT (for switch participants) in the past year and/or at least one T1-weighted Gd-enhancing lesion in the past year and/or at least one new or expanding T2 lesion in the past year at the time of enrollment
  • 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

Exclusion Criteria:

  • Diagnosis of secondary progressive MS without relapses for at least 1 year
  • Primary Progressive Multiple Sclerosis (PPMS)
  • Known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
  • History of recurrent aspiration pneumonia requiring antibiotic therapy
  • History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy)
  • Known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit
  • History of cancer, including solid tumors and hematological malignancies
  • Pregnant or lactating, or intending to become pregnant during the study
  • History of or currently active primary or secondary immunodeficiency
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History or known presence of systemic autoimmune disorders
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • Significant, uncontrolled disease including congestive heart failure, uncontrolled hypertension, pulmonary, renal, hepatic, endocrine, gastrointestinal, or any other significant disease
  • Known presence or history of other neurologic disorders
  • Prior treatment with any disease modifying therapy for MS other than interferon or glatiramer acetate or dimethylfumarate (DMF); or siponimod; or fingolimod
  • Previous treatment with cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
  • Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for MS
  • History of alcohol or other drug abuse within 24 weeks prior to enrollment
  • Vaccinations
  • Certain 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: October 19, 2020
Last Verified: October 2020
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