Multiple Sclerosis Clinical Trial

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)

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria
Disease duration from first symptom of less than or equal to ( 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:

History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
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)

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

608

Study ID:

NCT02637856

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 81 Locations for this study

See Locations Near You

North Central Neurology Associates
Cullman Alabama, 35058, United States
Phoenix Neurological Associates Ltd
Phoenix Arizona, 85006, United States
Barrow Neurological Institute
Phoenix Arizona, 85013, United States
Territory Neurology and Research Institute
Tucson Arizona, 85704, United States
The Research Center of Southern California, LLC
Carlsbad California, 92011, United States
Mercy Medical Group; MS Centre Nurse
Carmichael California, 95608, United States
Fullerton Neurology and Headache Center
Fullerton California, 92835, United States
Scripps Health
La Jolla California, 92037, United States
UCSF- Multiple Sclerosis Centre; Department of Neurology
San Francisco California, CA941, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance California, 90502, United States
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
Basalt Colorado, 81621, United States
IMMUNOe Research Centers
Centennial Colorado, 80112, United States
Colorado Neurological Institute
Englewood Colorado, 80113, United States
Advanced Neurology of Colorado, LLC
Fort Collins Colorado, 80528, United States
Associated Neurologists of Southern CT PC
Fairfield Connecticut, 06824, United States
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford Connecticut, 06905, United States
Neurology Associates PA
Maitland Florida, 32751, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami Florida, 33136, United States
Neurostudies Inc
Port Charlotte Florida, 33952, United States
Infinity Clinical Research, LLC
Sunrise Florida, 33351, United States
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States
University of South Florida - Bradenton
Tampa Florida, 33612, United States
Ms Center Of Atlanta
Atlanta Georgia, 30327, United States
University of Chicago Hospital
Chicago Illinois, 60637, United States
Consultants in Neurology Ltd
Northbrook Illinois, 60062, United States
American Health Network Institute, LLC
Avon Indiana, 46123, United States
Josephson Wallack Munshower Neurology PC
Indianapolis Indiana, 46256, United States
University of Kansas Medical Center; Division of Nuclear Medicine
Kansas City Kansas, 66160, United States
Lahey Clinic Med Ctr
Lexington Kentucky, 02421, United States
Associates in Neurology PSC
Lexington Kentucky, 40513, United States
Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services
Louisville Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
University of Maryland Medical Center; Department of Neurology
Baltimore Maryland, 21201, United States
John Hopkins University School of Medicine
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr; Neurology/MS Center
Boston Massachusetts, 02215, United States
Dragonfly Research, LLC
Wellesley Massachusetts, 02481, United States
UMASS Memorial Medical Center
Worcester Massachusetts, 01655, United States
Wayne State University; Department of Neurology
Detroit Michigan, 48201, United States
Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
Washington University School of Medicine; Department of Neurology
Saint Louis Missouri, 63110, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas Nevada, 89106, United States
Rutgers New Jersey Medical School
Newark New Jersey, 07103, United States
Holy Name Hospital; Institute For Clinical Research
Teaneck New Jersey, 07666, United States
Jacobs Neurological Institute
Buffalo New York, 14203, United States
The MS Center of Northeastern New York
Latham New York, 12110, United States
Columbia University Medical Center
New York New York, 10032, United States
South Shore Neurologic Associates P.C.
Patchogue New York, 11772, United States
Island Neurological Associates, P.C.
Plainview New York, 11803, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
UC Health Clinical Trials Office
Cincinnati Ohio, 45267, United States
Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
Cleveland Ohio, 44195, United States
The Ohio State University Wexner Medical Center; Department of Neurology
Columbus Ohio, 43210, United States
Neurology Specialists, Inc
Dayton Ohio, 45417, United States
Neurology and Neuroscience Assoc., Inc.
Westerville Ohio, 43081, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Providence Multiple Sclerosis Center
Portland Oregon, 97225, United States
Allegheny Neurological Associates
Pittsburgh Pennsylvania, 15212, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
Hope Neurology
Knoxville Tennessee, 37922, United States
Uni of Texas Health Science Center At Houston
Houston Texas, 77030, United States
Bhupesh Dihenia M.D. P.A.
Lubbock Texas, 79410, United States
Central Texas Neurology Consultants
Round Rock Texas, 78681, United States
Neurology Center of San Antonio
San Antonio Texas, 78212, United States
Rocky Mountain MS Clinic
Salt Lake City Utah, 84103, United States
Swedish Neuroscience Institute
Seattle Washington, 98122, United States
MultiCare Health System Institute for Research and Innovation
Tacoma Washington, 98405, United States
Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience
Calgary Alberta, T2N 2, Canada
University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,
Edmonton Alberta, T6C 2, Canada
Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy
Burnaby British Columbia, V5G 2, Canada
Horizon Health Network - Multiple Sclerosis Clinic
Saint John New Brunswick, E2L 4, Canada
Dalhousie Multiple Sclerosis Research Unit
Halifax Nova Scotia, B3H 4, Canada
Hamilton General Hospital
Hamilton Ontario, L8L 2, Canada
The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis
Ottawa Ontario, K1H 8, Canada
St. Michael's Hospital MS Clinic, MS Research Centre
Toronto Ontario, , Canada
Clinique NeuroOutaouais
Gatineau Quebec, J8Y 1, Canada
Recherche Sepmus, Inc.
Greenfield Park Quebec, J4V 2, Canada
Hopital Hotel Dieu de Levis
Levis Quebec, G6V 3, Canada
Chum Campus Notre Dame
Montreal Quebec, H2X 0, Canada
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal Quebec, H3A 2, Canada
MS Clinic Mauricie Bois Francs
Trois Rivieres Quebec, G8Z 3, Canada
CHU De Quebec Universite Laval
Quebec , G1J 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

608

Study ID:

NCT02637856

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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