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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing||Drug: Ocrelizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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 ]
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
|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|
|Study Director:||Clinical Trials||Hoffmann-La Roche|