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). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

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 participants with EDSS 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 (e.g., 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:

821

Study ID:

NCT01247324

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 140 Locations for this study

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21st Century Neurology
Phoenix Arizona, 85004, United States
Mercy Medical Group
Carmichael California, 95608, United States
Scripps Clinic
La Jolla California, 92037, United States
MS Center of California
Laguna Hills California, 92653, United States
Southern California Permanente Medical Group
Los Angeles California, 90027, United States
Neuro-Therapeutics Inc.
Pasadena California, 91105, United States
University of California at San Francisco
San Francisco California, 94115, United States
Health First Physicians Inc.
Melbourne Florida, 32901, United States
Mercy Research Institute
Miami Florida, 33133, United States
Miami Research Associates
South Miami Florida, 33143, United States
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States
University of South Florida
Tampa Florida, 33612, United States
Shepherd Center Inc.
Atlanta Georgia, 30309, United States
Emory University; Department of Neurology
Atlanta Georgia, 30322, United States
NeuroTrials Research, Inc.
Atlanta Georgia, 30342, United States
Northwestern University; Dept. of Neurology
Chicago Illinois, 60611, United States
Consultants in Neurology Ltd
Northbrook Illinois, 60062, United States
American Health Network Institute, LLC
Avon Indiana, 46123, United States
Massachusetts General Hospital.
Boston Massachusetts, 02114, United States
Michigan Neurology Associates P.C.
Clinton Township Michigan, 48035, United States
Michigan Institute for Neurological Disorders
Farmington Hills Michigan, 48334, United States
The Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
Washington University; Wash Uni. Sch. Of Med
Saint Louis Missouri, 63110, United States
The MS Center for Innovations In Care
Saint Louis Missouri, 63131, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
University of New Mexico
Albuquerque New Mexico, 87131, United States
The MS Center; Advance Neurology and Pain
Advance North Carolina, 27006, United States
Atrium Health Neurosciences Institute ? Charlotte
Charlotte North Carolina, 28204, United States
OnSite Clinical Solutions LLC
Charlotte North Carolina, 28277, United States
Neurology Associates PA
Hickory North Carolina, 28602, United States
University Neurology Inc.
Cincinnati Ohio, 45219, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43212, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Providence Neurological Specialties
Portland Oregon, 97225, United States
Albert Einstein Medical Center; Depatment of Neurosensory sciences
Philadelphia Pennsylvania, 19141, United States
Magee-Woman's Hospital
Pittsburgh Pennsylvania, 15213, 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
Uni of Vermont Medical Center;
Burlington Vermont, 05405, United States
Multicare Research Institute; Multicare Neuroscience Center of Washington
Tacoma Washington, 98405, United States
Instituto centenario
Buenos Aires , C1204, Argentina
Hospital Español
Ciudad Autonoma Bs As , C1209, Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario , S2000, Argentina
Royal North Shore Hospital; Department of Neurology
St Leonards New South Wales, 2065, Australia
Barmherzige Brueder Konventspital
Linz , 4040, Austria
AZ Sint Jan
Brugge , 8000, Belgium
Cliniques Universitaires Saint-Luc; Neurology
Bruxelles , 1200, Belgium
AZ Delta (Campus Rumbeke)
Roeselare , 8800, Belgium
Hospital das Clinicas - UFG;Reumatologia
Goiania GO, 74653, Brazil
IMV Pesquisa Neurológica
Porto Alegre RS, 90110, Brazil
Clinica Neurologica; Neurocirurgica de Joinville
Joinville SC, 89202, Brazil
MHAT Avis Medica; Neurology Department
Pleven , 5800, Bulgaria
First MHAT; Clinic of Neurology
Sofia , 1000, Bulgaria
MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders
Sofia , 1113, Bulgaria
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
Sofia , 1407, Bulgaria
Military Medical Academy; Neurology
Sofia , 1606, Bulgaria
Hospital Carlos Van Buren
Valparaiso , 23400, Chile
Fakultni nemocnice u sv. Anny; Neurologicka klinika
Brno , 656 9, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Nemocnice Jihlava; NEU-Neurologicke oddeleni
Jihlava , 58633, Czechia
Krajska Nemocnice Pardubice Neurologicka Klinika
Pardubice , 532 0, Czechia
VFN Praha Poliklinika Rs Centrum - Budova A
Prague , 12808, Czechia
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice , 415 2, Czechia
West Tallinn Central Hospital
Tallinn , 10617, Estonia
Tartu University Hospital
Tartu , 51014, Estonia
FinnMedi Oy
Tampere , 33520, Finland
Groupe Hospitalier Pellegrin
Bordeaux , 33000, France
CHU Hopital Gabriel Montpied; Service de Neurologie
Clermont Ferrand , 63003, France
Hopital Central; Neurologie
Nancy , 54035, France
CHU de Nîmes Hopital Caremeau; Service de Neurologie
Nimes , 30900, France
Hopital Hautepierre - CHU Strasbourg; Service de Neurologie
Strasbourg , 67098, France
Charité Universitaetsmedizin Berlin, Campus Charité Mitte
Berlin , 10117, Germany
Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden
Dresden , 01307, Germany
Asklepiosklinik Barmbek; Abteilung Neurologie
Hamburg , 22291, Germany
Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie
Hannover , 30171, Germany
Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
Mainz , 55131, Germany
Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie
Oldenburg , 26122, Germany
Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune
Prien , 83209, Germany
Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie
Rostock , 18147, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen , 72076, Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede , 26655, Germany
Semmelweis Egyetem AOK; Neurologiai Klinika
Budapest , 1083, Hungary
Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti
Budapest , 1204, Hungary
Szent Borbala Korhaz; Neurology
Tatabánya , 2800, Hungary
Chaim Sheba Medical Center; Neurology Department
Ramat-Gan , 52620, Israel
Azienda Ospedaliera Sant'Andrea
Roma Lazio, 00189, Italy
Irccs Ospedale San Raffaele
Milano Lombardia, 20132, Italy
Azienda Socio Sanitaria Territoriale della Valle Olona (pres
Gallarate Valle D?Aosta, 21013, Italy
Azienda Ospedaliera di Padova; Clinica Neurologica
Padova Veneto, 35128, Italy
Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
Riga , 1015, Latvia
P. Stradins Clinical University Hospital; Neurology
Riga , LV-10, Latvia
Kaunas Medical University Hospital
Kaunas , 50009, Lithuania
Klaipeda University Hospital Public Institution
Klaipeda , 92288, Lithuania
Vilnius University Hospital Santariskiu Clinic
Vilnius , 08661, Lithuania
Grupo Médico Camino S.C.
Ciudad de México Mexico CITY (federal District), 03600, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
Monterrey Nuevo LEON, 64460, Mexico
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein , 3435 , Netherlands
Policlinico Especializado en Neurologia
Callao , 04, Peru
Clinica Anglo Americana
Lima , 18, Peru
Hospital Nacional Dos de Mayo
Lima , , Peru
Clinica Centenario Peruano Japonesa; Neurology
Pueblo Libre , Lima , Peru
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
Gdansk , 80-80, Poland
Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
Katowice , 40-58, Poland
MA-LEK Clinical Sp. Z o.o.
Katowice , 40-59, Poland
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
Plewiska , 62-06, Poland
Hospital de Braga; Servico de Neurologia
Braga , 4710-, Portugal
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva Moskovskaja Oblast, 10715, Russian Federation
FGBU FNKC FMBA of Russia
Moskva Moskovskaja Oblast, 11568, Russian Federation
St.-Peterburg State institution of health care City multifield hospital #2
Sankt-peterburg Sankt Petersburg, 19435, Russian Federation
MMA of Ministry of Defense of Russia named after S.M. Kirov
St.Petersburg Sankt Petersburg, 19404, Russian Federation
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg Sverdlovsk, 62010, Russian Federation
Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"
Tyumen Tjumen, 62500, Russian Federation
Kemerovo Regional Clinical Hospital
Kemerovo , 65006, Russian Federation
FSBIH Siberian Regional Medical Centre of FMBA of Russia
Novosibirsk , 63000, Russian Federation
MRC for Oncology and Neurology Biotherapy
Novosibirsk , 63009, Russian Federation
Samara State Medical University
Samara , 44309, Russian Federation
Reg. SI of Health Care Smolensk Regional Clinical Hospital
Smolensk , 21401, Russian Federation
Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"
Tyumen , 62500, Russian Federation
Military Medical Academy
Belgrade , 11040, Serbia
Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Clinical Center Nis
NIS , 18000, Serbia
FNsP Bratislava - Nemocnica Stare mesto
Bratislava , 813 6, Slovakia
FNsP Bratislava, Nemocnica Ruzinov
Bratislava , 826 0, Slovakia
Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren
Bratislava , 851 0, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Zilina , 012 0, Slovakia
Dr CC Coetzee Inc
Durban , 4319, South Africa
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
Santa Cruz De Tenerife Tenerife, 38010, Spain
Hospital de Basurto
Bilbao Vizcaya, 48013, Spain
Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
Madrid , 28222, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
Basel , 4031, Switzerland
Ospedale Regionale Lugano Civico Medizin Neurologie; Neurologia
Lugano , 6900, Switzerland
Hopital Razi
Mannouba , 2010, Tunisia
Hopital Universitaire Fattouma Bourguiba
Monastir , 5000, Tunisia
Hopital Charles Nicolle
Tunis , 1006, Tunisia
MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics
Donetsk , 83099, Ukraine
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis
Kharkov , 61068, Ukraine
Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology
Kyiv , 03110, Ukraine
Lviv Regional Clinical Hospital; Department of Neurology
Lviv , 79010, Ukraine
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
Vinnytsya , 21005, Ukraine
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool , L9 7L, United Kingdom
Royal London Hospital; Neurology
London , E1 1B, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

821

Study ID:

NCT01247324

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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