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 :
Active, not recruiting
First Posted : May 6, 2020
Last Update Posted : April 9, 2024
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Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis, Relapsing | Drug: Ocrelizumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 179 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 : | December 29, 2025 |
Estimated Study Completion Date : | December 29, 2025 |
Arm | Intervention/treatment |
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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.
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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. |
- 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)
- 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 ]
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.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT04377555 |
Other Study ID Numbers: |
ML42071 |
First Posted: | May 6, 2020 Key Record Dates |
Last Update Posted: | April 9, 2024 |
Last Verified: | April 2024 |
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). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |