Multiple Sclerosis Clinical Trial
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Summary
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Eligibility Criteria
Inclusion Criteria:
Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
Neurologic stability for greater than or equal to (>/=) 30 days prior to both screening and baseline
Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
Exclusion Criteria:
Primary progressive multiple sclerosis
Disease duration of more than 10 years in patients with EDSS score less than or equal to (=) 2.0 at screening
Contraindications for MRI
Known presence of other neurological disorders which may mimic multiple sclerosis
Pregnancy or lactation
Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
History of or currently active primary or secondary immunodeficiency
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 (for example, hepatitis B or C, Human Immunodeficiency Virus [HIV], syphilis, tuberculosis)
History of progressive multifocal leukoencephalopathy
Contraindications to or intolerance of oral or IV corticosteroids
Contraindications to Rebif or incompatibility with Rebif use
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There are 162 Locations for this study
Phoenix Arizona, 85050, United States
Scottsdale Arizona, 85251, United States
Tucson Arizona, 85704, United States
Long Beach California, 90806, United States
Palo Alto California, 94304, United States
Denver Colorado, 80262, United States
Fort Collins Colorado, 80528, United States
Fairfield Connecticut, 06824, United States
Hollywood Florida, 33024, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Sarasota Florida, 34292, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30327, United States
Indianapolis Indiana, 46256, United States
Kansas City Kansas, 66160, United States
Prairie Village Kansas, 66206, United States
Lexington Kentucky, 40513, United States
Wellesley Massachusetts, 02481, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Golden Valley Minnesota, 55422, United States
Newark New Jersey, 07103, United States
Teaneck New Jersey, 07666, United States
Teaneck New Jersey, 07666, United States
Toms River New Jersey, 08755, United States
Latham New York, 12210, United States
New York New York, 63110, United States
Patchogue New York, 11772, United States
Rochester New York, 14642, United States
Stony Brook New York, 11790, United States
Charlotte North Carolina, 28204, United States
Hickory North Carolina, 28602, United States
Raleigh North Carolina, 27607, United States
Columbus Ohio, 43801, United States
Abington Pennsylvania, 19001, United States
Greenville South Carolina, 29607, United States
Cordova Tennessee, 38018, United States
Knoxville Tennessee, 37934, United States
Nashville Tennessee, 37205, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78258, United States
Seattle Washington, 98122, United States
Buenos Aires , C1425, Argentina
Ciudad de Buenos Airesa , C1013, Argentina
Grodno Hrodzyenskaya Voblasts', 23001, Belarus
Vitebsk Vitsyebskaya Voblasts', 21002, Belarus
Vitebsk Vitsyebskaya Voblasts', 21003, Belarus
Minsk , 22011, Belarus
Edegem , 2650, Belgium
Sarajevo , 71 00, Bosnia and Herzegovina
Tuzla , 75000, Bosnia and Herzegovina
Belo Horizonte MG, 30150, Brazil
Rio de Janeiro RJ, 20270, Brazil
Campinas SP, 13083, Brazil
Sofia , 1113, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1431, Bulgaria
Calgary Alberta, T2N 2, Canada
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V6Z 1, Canada
Ottawa Ontario, K1H 8, Canada
Gatineau Quebec, J8Y 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3A 2, Canada
Montréal Quebec, H1T 2, Canada
Pula , 52100, Croatia
Varazdin , 42000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Brno , 613 0, Czechia
Havirov , 736 0, Czechia
Pardubice , 532 0, Czechia
Teplice , 415 2, Czechia
Bron , 69500, France
Dijon Cedex , 21079, France
Lommé , 59462, France
Paris , 75651, France
Reims , 51092, France
Toulouse , 31059, France
Berlin , 10713, Germany
Bonn , 53117, Germany
Düsseldorf , 40225, Germany
Essen , 45138, Germany
Frankfurt , 60528, Germany
Heidelberg , 69120, Germany
Mittweida , 09648, Germany
Muenchen , 81377, Germany
München , 81675, Germany
Ulm , 89073, Germany
Dublin 4 , , Ireland
Roma Lazio, 00133, Italy
Roma Lazio, 00168, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20133, Italy
Montichiari Lombardia, 25018, Italy
Torrette - Ancona Marche, 60100, Italy
Ponderano Piemonte, 13875, Italy
Acquaviva delle Fonti Puglia, 70021, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Cefalu Sicilia, 90015, Italy
Guadalajara Jalisco, 44620, Mexico
Ciudad de México Mexico CITY (federal District), 03100, Mexico
Tlalnepantla de Baz Mexico CITY (federal District), 54055, Mexico
Culiacán Rosales Sinaloa, 80020, Mexico
Aguascalientes , 20127, Mexico
Chihuahua , 31238, Mexico
Bergen , 5053, Norway
Bydgoszcz , 85-02, Poland
Katowice , 40-59, Poland
Krakow , 31-50, Poland
Lodz , 90-15, Poland
Lodz , 90-32, Poland
Lublin , 20-95, Poland
Olsztyn , 10-56, Poland
Siemianowice ?l?skie , 41-10, Poland
Warszawa , 01-68, Poland
Barnaul Altaj, 65602, Russian Federation
Sankt-peterburg Sankt Petersburg, 19702, Russian Federation
Pyatigorsk Stavropol, 35753, Russian Federation
Kazan Tatarstan, 42010, Russian Federation
Kirov , 61001, Russian Federation
Nizniy Novgorod , 60315, Russian Federation
Perm , 61499, Russian Federation
Saratov , 41001, Russian Federation
Banska Bystrica , 974 0, Slovakia
Banska Bystrica , 975 1, Slovakia
Levoca , 054 0, Slovakia
Badalona Barcelona, 08916, Spain
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Alicante , 03010, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Girona , 17007, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Malaga , 29010, Spain
Valencia , 46010, Spain
Göteborg , 413 4, Sweden
Stockholm , 113 4, Sweden
Stockholm , 171 6, Sweden
Umeå , 901 8, Sweden
Ankara , 06100, Turkey
Istanbul , 34096, Turkey
Istanbul , 34098, Turkey
Istanbul , 34394, Turkey
Izmir , 35100, Turkey
Kocaeli , 41380, Turkey
Samsun , 55139, Turkey
Trabzon , 61080, Turkey
Chernihiv , 14029, Ukraine
Dnipropetrovsk , 49102, Ukraine
Donetsk , 83045, Ukraine
Donetsk , 83114, Ukraine
Ivano-Frankivsk , 76008, Ukraine
Exeter , EX2 5, United Kingdom
London , SE5 9, United Kingdom
Stoke on Trent , ST4 6, United Kingdom
Swansea , SA6 6, United Kingdom
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