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).

View Eligibility Criteria

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 ( 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

835

Study ID:

NCT01412333

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 162 Locations for this study

See Locations Near You

Hope Research Institute
Phoenix Arizona, 85050, United States
HonorHealth Neurology
Scottsdale Arizona, 85251, United States
Territory Neurology and Research Institute
Tucson Arizona, 85704, United States
Collaborative Neuroscience Research, LLC
Long Beach California, 90806, United States
Stanford University Medical Center
Palo Alto California, 94304, United States
University of Colorado
Denver Colorado, 80262, United States
Advanced Neurosciences Research LLC
Fort Collins Colorado, 80528, United States
Associated Neurologists of Southern CT PC
Fairfield Connecticut, 06824, United States
Infinity Clinical Research
Hollywood Florida, 33024, United States
University of Miami; Dept. of Neurology MS Center
Miami Florida, 33136, United States
Neurological Services of Orlando
Orlando Florida, 32806, United States
Lovelace Scientific Resources
Sarasota Florida, 34292, United States
University of South Florida
Tampa Florida, 33612, United States
Atlanta Neuroscience Institute
Atlanta Georgia, 30327, United States
Josephson Wallack Munshower Neurology PC
Indianapolis Indiana, 46256, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
MidAmerica Neuroscience Institute
Prairie Village Kansas, 66206, United States
Associates in Neurology PSC
Lexington Kentucky, 40513, United States
Dragonfly Research, LLC
Wellesley Massachusetts, 02481, United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
Wayne State University; Department of Neurology
Detroit Michigan, 48201, United States
The Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
Rutgers New Jersey Medical School
Newark New Jersey, 07103, United States
Holy Name Hospital
Teaneck New Jersey, 07666, United States
MS Comprehensive Care Center
Teaneck New Jersey, 07666, United States
Shore Neurology
Toms River New Jersey, 08755, United States
Empire Neurology, PC
Latham New York, 12210, United States
Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
New York New York, 63110, United States
South Shore Neurologic Associates P.C.
Patchogue New York, 11772, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
SUNY at Stony Brook
Stony Brook New York, 11790, United States
The Neurological Institute PA
Charlotte North Carolina, 28204, United States
Neurology Associates PA
Hickory North Carolina, 28602, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
Columbus Neuroscience
Columbus Ohio, 43801, United States
Abington Neurological Associates
Abington Pennsylvania, 19001, United States
Absher Neurology PA
Greenville South Carolina, 29607, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
Sibyl Wray MD Neurology PC
Knoxville Tennessee, 37934, United States
Advanced Neurosciences Institute
Nashville Tennessee, 37205, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Baylor College of Medicine
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
Integra Clinical Research, Llc
San Antonio Texas, 78229, United States
Neurology Center of San Antonio
San Antonio Texas, 78258, United States
Swedish Neuroscience Institute
Seattle Washington, 98122, United States
ALPI-Inst. de Rehabilitacion Marcelo Fitte
Buenos Aires , C1425, Argentina
STAT Research S.A.
Ciudad de Buenos Airesa , C1013, Argentina
Grodno State Medical University
Grodno Hrodzyenskaya Voblasts', 23001, Belarus
Vitebsk; Regional Diagnostic Center
Vitebsk Vitsyebskaya Voblasts', 21002, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk Vitsyebskaya Voblasts', 21003, Belarus
City Clinical Hospital #9
Minsk , 22011, Belarus
UZ Antwerpen
Edegem , 2650, Belgium
University Clinic Ctr Sarajevo
Sarajevo , 71 00, Bosnia and Herzegovina
Uni Hospital Center Tuzla
Tuzla , 75000, Bosnia and Herzegovina
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte MG, 30150, Brazil
Hospital Universitario Gaffree e Guinle
Rio de Janeiro RJ, 20270, Brazil
Hospital das Clinicas - UNICAMP
Campinas SP, 13083, Brazil
MHATNP Sv.Naum EAD; Clinic for intensive treatment of neurology diseases
Sofia , 1113, Bulgaria
Fifth MHAT-Sofia AD; Neuro Dept with Vascular Unit
Sofia , 1233, Bulgaria
MHAT National Cardiology Hospital, EAD; Neurology
Sofia , 1309, Bulgaria
UMHAT Alexandrovska, EAD; Neurology
Sofia , 1431, Bulgaria
Multiple Sclerosis Clinic
Calgary Alberta, T2N 2, Canada
University of Alberta; Northern Alberta Trials & Research Centre
Edmonton Alberta, T6G 2, Canada
Vancouver Hospital - UBC Hospital Site
Vancouver British Columbia, V6Z 1, Canada
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
Clinique NeuroOutaouais
Gatineau Quebec, J8Y 1, Canada
Recherche Sepmus Inc.
Greenfield Park Quebec, J4V 2, Canada
Montreal Neurological Institute and Hospital
Montreal Quebec, H3A 2, Canada
Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie
Montréal Quebec, H1T 2, Canada
General Hospital Pula
Pula , 52100, Croatia
General Hospital Varazdin
Varazdin , 42000, Croatia
Clinical Hospital Centre Zagreb;Clinic for Neurology
Zagreb , 10000, Croatia
Uni Hospital Centre Dubrava
Zagreb , 10000, Croatia
Fakultni nemocnice Brno
Brno , 613 0, Czechia
Neurospol s.r.o.
Havirov , 736 0, Czechia
Pardubicka Krajska Nemocnice; Department of Neurology
Pardubice , 532 0, Czechia
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice , 415 2, Czechia
Hopital Neurologique Pierre Wertheimer
Bron , 69500, France
Hôpital General - Service de neurologie; Service de neurologie
Dijon Cedex , 21079, France
Hôpital Saint Philibert
Lommé , 59462, France
Groupe Hospitalier Pitie-Salpetriere
Paris , 75651, France
Hôpital Maison Blanche; Service de Neurologie
Reims , 51092, France
CHU toulouse - Hôpital Purpan; Departement de Neurologie
Toulouse , 31059, France
Sankt Gertrauden Krankenhaus; Neurologisches Facharztzentrum
Berlin , 10713, Germany
Neurologische Praxis Bonn
Bonn , 53117, Germany
Universitätsklinikum Düsseldorf; Klinik für Neurologie
Düsseldorf , 40225, Germany
Zentrum fuer ambulante Neurologie
Essen , 45138, Germany
Universitaetsklinikum Frankfurt; Klinik für Neurologie
Frankfurt , 60528, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Ratsapotheke Mittweida
Mittweida , 09648, Germany
Klinikum Grosshadern der LMU
Muenchen , 81377, Germany
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München , 81675, Germany
Neurologische Gemeinschaftspraxis Dr. Lang, Prof. Schreiber, Dr. Krauß, Dr. Kornhuber
Ulm , 89073, Germany
St Vincents University Hospital
Dublin 4 , , Ireland
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma Lazio, 00133, Italy
Policlinico Universitario Agostino Gemelli
Roma Lazio, 00168, Italy
A.O. Universitaria S. Martino Di Genova
Genova Liguria, 16132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna
Milano Lombardia, 20133, Italy
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari Lombardia, 25018, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Torrette - Ancona Marche, 60100, Italy
Ospedale degli Infermi
Ponderano Piemonte, 13875, Italy
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti Puglia, 70021, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo Puglia, 71013, Italy
Fond. Ist. S. Raffaele - giglio
Cefalu Sicilia, 90015, Italy
Hospital Mexico Americano SC; Departamento de Electroencefalografía
Guadalajara Jalisco, 44620, Mexico
Mexico Centre for Clinical Research
Ciudad de México Mexico CITY (federal District), 03100, Mexico
Clinical Research Institute
Tlalnepantla de Baz Mexico CITY (federal District), 54055, Mexico
Hospital Angeles Culiacan; Neurociencias
Culiacán Rosales Sinaloa, 80020, Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes , 20127, Mexico
Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4
Chihuahua , 31238, Mexico
Haukeland Universitetssykehus
Bergen , 5053, Norway
Vitamed
Bydgoszcz , 85-02, Poland
MA-LEK Clinical Sp. Z o.o.
Katowice , 40-59, Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow , 31-50, Poland
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
Lodz , 90-15, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz , 90-32, Poland
Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie
Lublin , 20-95, Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym
Olsztyn , 10-56, Poland
Neuro-Care Gabriela Klodowska
Siemianowice ?l?skie , 41-10, Poland
mMED Maciej Czarnecki
Warszawa , 01-68, Poland
State institution of health care - Territorial Clinical Hospital
Barnaul Altaj, 65602, Russian Federation
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Sankt-peterburg Sankt Petersburg, 19702, Russian Federation
City Clinical Hospital#2
Pyatigorsk Stavropol, 35753, Russian Federation
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan Tatarstan, 42010, Russian Federation
Kirov City Clinical Hospital #1; Neurology Department
Kirov , 61001, Russian Federation
SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department
Nizniy Novgorod , 60315, Russian Federation
Perm SMA n.a. academ. E.A. Vagner
Perm , 61499, Russian Federation
Saratov State Medical University of RosZdrav; Neurology
Saratov , 41001, Russian Federation
MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
Banska Bystrica , 974 0, Slovakia
Fakultna Nemocnica Roosevelta
Banska Bystrica , 975 1, Slovakia
Vseobecna nemocnica s poliklinikou Levoca a.s.
Levoca , 054 0, Slovakia
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital General Univ. de Alicante
Alicante , 03010, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona , 17007, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
Madrid , 28007, Spain
Hospital Universitario Clinico San Carlos
Madrid , 28040, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
Valencia , 46010, Spain
Sahlgrenska Sjukhuset; Neurology
Göteborg , 413 4, Sweden
Karolinska Universitetssjukhuset Solna Neurology
Stockholm , 113 4, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm , 171 6, Sweden
Norrlands Universitetssjukhus
Umeå , 901 8, Sweden
Hacettepe University Medical Faculty; Neurology
Ankara , 06100, Turkey
Haseki Training and Research Hospital
Istanbul , 34096, Turkey
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
Istanbul , 34098, Turkey
Istanbul Bilim Universty Medical Fac.
Istanbul , 34394, Turkey
Ege University Medical Faculty
Izmir , 35100, Turkey
Kocaeli University Medical Faculty
Kocaeli , 41380, Turkey
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun , 55139, Turkey
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon , 61080, Turkey
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?; Neurology Department
Chernihiv , 14029, Ukraine
City Clinical Hospital #4
Dnipropetrovsk , 49102, Ukraine
State Institution V.K. Gusak Institute of Urgent and Recover; Dep of Reconstructive Angioneurology a
Donetsk , 83045, Ukraine
Road Clinical Hospital of Donetsk Station; Neurology Department
Donetsk , 83114, Ukraine
Regional Clinical Hospital; Neurology Department
Ivano-Frankivsk , 76008, Ukraine
Royal Devon and Exeter Hospital (Wonford)
Exeter , EX2 5, United Kingdom
Kings College Hospital; Neurosciences Clinical Trials Office
London , SE5 9, United Kingdom
City General Hospital; Department of Neurology
Stoke on Trent , ST4 6, United Kingdom
Morriston Hospital
Swansea , SA6 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

835

Study ID:

NCT01412333

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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