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An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.
Participants who complete their Week 72 ocrelizumab infusion and do not experience any serious infusion related reaction (IRR) throughout the main study will be eligible to enroll in an optional, open-label, non-randomized substudy to MN30035 and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. This substudy will enroll approximately 100 patients from MN30035 main study.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
North Central Neurology Associates
Cullman, Alabama, United States
Phoenix Neurological Associates Ltd
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Territory Neurology and Research Institute
Tucson, Arizona, United States
The Research Center of Southern California, LLC
Carlsbad, California, United States
Mercy Medical Group; MS Centre Nurse
Carmichael, California, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Scripps Health
La Jolla, California, United States
UCSF- Multiple Sclerosis Centre; Department of Neurology
San Francisco, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Start Date
February 11, 2016
Primary Completion Date
May 3, 2019
Completion Date
May 3, 2019
Last Updated
May 26, 2020
608
ACTUAL participants
Ocrelizumab
DRUG
Ocrelizumab
DRUG
Lead Sponsor
Genentech, Inc.
NCT05359653
NCT06390930
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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