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.
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.
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 (=) 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:
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)
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There are 81 Locations for this study
Cullman Alabama, 35058, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85013, United States
Tucson Arizona, 85704, United States
Carlsbad California, 92011, United States
Carmichael California, 95608, United States
Fullerton California, 92835, United States
La Jolla California, 92037, United States
San Francisco California, CA941, United States
Torrance California, 90502, United States
Basalt Colorado, 81621, United States
Centennial Colorado, 80112, United States
Englewood Colorado, 80113, United States
Fort Collins Colorado, 80528, United States
Fairfield Connecticut, 06824, United States
Stamford Connecticut, 06905, United States
Maitland Florida, 32751, United States
Miami Florida, 33136, United States
Port Charlotte Florida, 33952, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33609, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30327, United States
Chicago Illinois, 60637, United States
Northbrook Illinois, 60062, United States
Avon Indiana, 46123, United States
Indianapolis Indiana, 46256, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 02421, United States
Lexington Kentucky, 40513, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Wellesley Massachusetts, 02481, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Golden Valley Minnesota, 55422, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89106, United States
Newark New Jersey, 07103, United States
Teaneck New Jersey, 07666, United States
Buffalo New York, 14203, United States
Latham New York, 12110, United States
New York New York, 10032, United States
Patchogue New York, 11772, United States
Plainview New York, 11803, United States
Raleigh North Carolina, 27607, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Dayton Ohio, 45417, United States
Westerville Ohio, 43081, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97225, United States
Pittsburgh Pennsylvania, 15212, United States
Cordova Tennessee, 38018, United States
Knoxville Tennessee, 37922, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78212, United States
Salt Lake City Utah, 84103, United States
Seattle Washington, 98122, United States
Tacoma Washington, 98405, United States
Calgary Alberta, T2N 2, Canada
Edmonton Alberta, T6C 2, Canada
Burnaby British Columbia, V5G 2, Canada
Saint John New Brunswick, E2L 4, Canada
Halifax Nova Scotia, B3H 4, Canada
Hamilton Ontario, L8L 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, , Canada
Gatineau Quebec, J8Y 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Levis Quebec, G6V 3, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3A 2, Canada
Trois Rivieres Quebec, G8Z 3, Canada
Quebec , G1J 1, Canada
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