A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
NCT ID: NCT02637856
Last Updated: 2020-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
608 participants
INTERVENTIONAL
2016-02-11
2019-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ocrelizumab
Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).
Ocrelizumab
Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).
Ocrelizumab (substudy)
Participants with no serious IRR throughout the main study will be eligible to enroll in an optional substudy and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab will be administered IV as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Ocrelizumab
Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Interventions
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Ocrelizumab
Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).
Ocrelizumab
Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease duration from first symptom of less than or equal to (\</=) 12 years
* Treated with an adequate course of treatment with no more than three prior DMT regimens of greater than or equal to (\>/=) 6 months, and the discontinuation of the most recent adequately used DMT was due to suboptimal response
* Suboptimal response while the participant was on his/her last adequately used DMT for \>/=6 months (defined by having one of the following qualifying events despite being on a stable dose of the same DMT for at least 6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); these qualifying events must have occurred while on the last adequately used DMT. In participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT from the date of screening
Exclusion Criteria
* Contraindications for MRI
* Known presence of other neurological disorders that may mimic multiple sclerosis
* Pregnancy or lactation, or intention to become pregnant during the study
* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History of or currently active primary or secondary immunodeficiency
* Lack of peripheral venous access
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Active infection, or history of or known presence of recurrent or chronic infection such as human immunodeficiency virus (HIV), syphilis, or tuberculosis
* History of progressive multifocal leukoencephalopathy
* Contraindications to or intolerance of oral or IV corticosteroids
* Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in participants whose lymphocyte count is below the lower limit of normal (LLN)
* Treatment with alemtuzumab (Lemtrada®)
* Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate
* Previous treatment with natalizumab within 12 months prior to screening unless failure was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously treated with natalizumab will be eligible for this study only if duration of treatment with natalizumab was less than (\<) 1 year and natalizumab was not used in the 12 months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive or negative) and titer (both assessed within the year of screening) must be documented prior to enrollment
* Treatment with dalfampridine (Ampyra®) unless on stable dose for \>/=30 days prior to screening
* Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
* Treatment with a drug that is experimental (Exception: treatment with an experimental drug that was subsequently approved in the participant's country is allowed)
18 Years
55 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
Basalt, Colorado, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Associated Neurologists of Southern CT PC
Fairfield, Connecticut, United States
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States
Neurology Associates PA
Maitland, Florida, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University of South Florida - Bradenton
Tampa, Florida, United States
Ms Center Of Atlanta
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Consultants in Neurology Ltd
Northbrook, Illinois, United States
American Health Network Institute, LLC
Avon, Indiana, United States
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, United States
University of Kansas Medical Center; Division of Nuclear Medicine
Kansas City, Kansas, United States
Lahey Clinic Med Ctr
Lexington, Kentucky, United States
Associates in Neurology PSC
Lexington, Kentucky, United States
Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Medical Center; Department of Neurology
Baltimore, Maryland, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr; Neurology/MS Center
Boston, Massachusetts, United States
Dragonfly Research, LLC
Wellesley, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Wayne State University; Department of Neurology
Detroit, Michigan, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Washington University School of Medicine; Department of Neurology
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Holy Name Hospital; Institute For Clinical Research
Teaneck, New Jersey, United States
Jacobs Neurological Institute
Buffalo, New York, United States
The MS Center of Northeastern New York
Latham, New York, United States
Columbia University Medical Center
New York, New York, United States
South Shore Neurologic Associates P.C.
Patchogue, New York, United States
Island Neurological Associates, P.C.
Plainview, New York, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, United States
Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center; Department of Neurology
Columbus, Ohio, United States
Neurology Specialists, Inc
Dayton, Ohio, United States
Neurology and Neuroscience Assoc., Inc.
Westerville, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Providence Multiple Sclerosis Center
Portland, Oregon, United States
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, United States
Neurology Clinic PC
Cordova, Tennessee, United States
Hope Neurology
Knoxville, Tennessee, United States
Uni of Texas Health Science Center At Houston
Houston, Texas, United States
Bhupesh Dihenia M.D. P.A.
Lubbock, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
Rocky Mountain MS Clinic
Salt Lake City, Utah, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States
Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience
Calgary, Alberta, Canada
University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,
Edmonton, Alberta, Canada
Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy
Burnaby, British Columbia, Canada
Horizon Health Network - Multiple Sclerosis Clinic
Saint John, New Brunswick, Canada
Dalhousie Multiple Sclerosis Research Unit
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
Ottawa, Ontario, Canada
St. Michael's Hospital MS Clinic, MS Research Centre
Toronto, Ontario, Canada
Clinique NeuroOutaouais
Gatineau, Quebec, Canada
Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada
Hopital Hotel Dieu de Levis
Lévis, Quebec, Canada
Chum Campus Notre Dame
Montreal, Quebec, Canada
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, Canada
MS Clinic Mauricie Bois Francs
Trois-Rivières, Quebec, Canada
CHU De Quebec Universite Laval
Québec, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MN30035
Identifier Type: -
Identifier Source: org_study_id
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