A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
NCT ID: NCT01247324
Last Updated: 2024-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
821 participants
INTERVENTIONAL
2011-08-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Interferon beta-1a 44 mcg SC
Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Interferon beta-1a
Ocrelizumab-matching placebo
Ocrelizumab
Ocrelizumab 600 mg 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.
Ocrelizumab
Interferon beta-1a-matching placebo
Interventions
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Interferon beta-1a
Ocrelizumab-matching placebo
Ocrelizumab
Interferon beta-1a-matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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21st Century Neurology
Phoenix, Arizona, United States
Mercy Medical Group
Carmichael, California, United States
Scripps Clinic
La Jolla, California, United States
MS Center of California
Laguna Hills, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Neuro-Therapeutics Inc.
Pasadena, California, United States
University of California at San Francisco
San Francisco, California, United States
Health First Physicians Inc.
Melbourne, Florida, United States
Mercy Research Institute
Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Shepherd Center Inc.
Atlanta, Georgia, United States
Emory University; Department of Neurology
Atlanta, Georgia, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Northwestern University; Dept. of Neurology
Chicago, Illinois, United States
Consultants in Neurology Ltd
Northbrook, Illinois, United States
American Health Network Institute, LLC
Avon, Indiana, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
Michigan Neurology Associates P.C.
Clinton Township, Michigan, United States
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States
The Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, United States
The MS Center for Innovations In Care
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of New Mexico
Albuquerque, New Mexico, United States
The MS Center; Advance Neurology and Pain
Advance, North Carolina, United States
Atrium Health Neurosciences Institute ? Charlotte
Charlotte, North Carolina, United States
OnSite Clinical Solutions LLC
Charlotte, North Carolina, United States
Neurology Associates PA
Hickory, North Carolina, United States
University Neurology Inc.
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Providence Neurological Specialties
Portland, Oregon, United States
Albert Einstein Medical Center; Depatment of Neurosensory sciences
Philadelphia, Pennsylvania, United States
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, United States
Uni of Texas Health Science Center At Houston
Houston, Texas, United States
Bhupesh Dihenia M.D. P.A.
Lubbock, Texas, United States
Uni of Vermont Medical Center;
Burlington, Vermont, United States
Multicare Research Institute; Multicare Neuroscience Center of Washington
Tacoma, Washington, United States
Instituto centenario
Buenos Aires, , Argentina
Hospital Español
Ciudad Autonoma Bs As, , Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario, , Argentina
Royal North Shore Hospital; Department of Neurology
St Leonards, New South Wales, Australia
Barmherzige Brueder Konventspital
Linz, , Austria
AZ Sint Jan
Bruges, , Belgium
Cliniques Universitaires Saint-Luc; Neurology
Brussels, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
Hospital das Clinicas - UFG;Reumatologia
Goiânia, Goiás, Brazil
IMV Pesquisa Neurológica
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Neurologica; Neurocirurgica de Joinville
Joinville, Santa Catarina, Brazil
MHAT Avis Medica; Neurology Department
Pleven, , Bulgaria
First MHAT; Clinic of Neurology
Sofia, , Bulgaria
MHATNP Sv.Naum EAD; Clinic in neurology diseases for movement disorders
Sofia, , Bulgaria
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
Sofia, , Bulgaria
Military Medical Academy; Neurology
Sofia, , Bulgaria
Hospital Carlos Van Buren
Valparaíso, , Chile
Fakultni nemocnice u sv. Anny; Neurologicka klinika
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Nemocnice Jihlava; NEU-Neurologicke oddeleni
Jihlava, , Czechia
Krajska Nemocnice Pardubice Neurologicka Klinika
Pardubice, , Czechia
VFN Praha Poliklinika Rs Centrum - Budova A
Prague, , Czechia
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice, , Czechia
West Tallinn Central Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
FinnMedi Oy
Tampere, , Finland
Groupe Hospitalier Pellegrin
Bordeaux, , France
CHU Hopital Gabriel Montpied; Service de Neurologie
Clermont-Ferrand, , France
Hopital Central; Neurologie
Nancy, , France
CHU de Nîmes Hopital Caremeau; Service de Neurologie
Nîmes, , France
Hopital Hautepierre - CHU Strasbourg; Service de Neurologie
Strasbourg, , France
Charité Universitaetsmedizin Berlin, Campus Charité Mitte
Berlin, , Germany
Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden
Dresden, , Germany
Asklepiosklinik Barmbek; Abteilung Neurologie
Hamburg, , Germany
Diakoniekrankenhaus Henriettenstiftung gGMBH; Klinik für Neurologie und klinische Neurophysiologie
Hanover, , Germany
Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
Mainz, , Germany
Praxis Dr. med. Mathias Niedhammer, Facharzt für Neurologie
Oldenburg, , Germany
Neurozentrum Prien Elisabeth Hans-Thümmler Stefan Braune
Prien am Chiemsee, , Germany
Universitätsklinikum Rostock, Zentrum für Nervenheilkunde; Klinik und Poliklinik für Neurologie
Rostock, , Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, , Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede, , Germany
Semmelweis Egyetem AOK; Neurologiai Klinika
Budapest, , Hungary
Fovarosi Onkormanyzat Jahn Ferenc Del-Pesti
Budapest, , Hungary
Szent Borbala Korhaz; Neurology
Tatabánya, , Hungary
Chaim Sheba Medical Center; Neurology Department
Ramat Gan, , Israel
Azienda Socio Sanitaria Territoriale della Valle Olona (pres
Gallarate, Aosta Valley, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, Italy
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Azienda Ospedaliera di Padova; Clinica Neurologica
Padua, Veneto, Italy
Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
Riga, , Latvia
P. Stradins Clinical University Hospital; Neurology
Riga, , Latvia
Kaunas Medical University Hospital
Kaunas, , Lithuania
Klaipeda University Hospital Public Institution
Klaipėda, , Lithuania
Vilnius University Hospital Santariskiu Clinic
Vilnius, , Lithuania
Grupo Médico Camino S.C.
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, , Netherlands
Policlinico Especializado en Neurologia
Callao, , Peru
Clinica Anglo Americana
Lima, , Peru
Hospital Nacional Dos de Mayo
Lima, , Peru
Clinica Centenario Peruano Japonesa; Neurology
Pueblo Libre, , Peru
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
Gdansk, , Poland
Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
Katowice, , Poland
MA-LEK Clinical Sp. Z o.o.
Katowice, , Poland
Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych
Plewiska, , Poland
Hospital de Braga; Servico de Neurologia
Braga, , Portugal
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva, Moscow Oblast, Russia
FGBU FNKC FMBA of Russia
Moskva, Moscow Oblast, Russia
MMA of Ministry of Defense of Russia named after S.M. Kirov
Saint Petersburg, Sankt-Peterburg, Russia
St.-Peterburg State institution of health care City multifield hospital #2
Saint Petersburg, Sankt-Peterburg, Russia
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg, Sverdlovsk Oblast, Russia
Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"
Tyumen, Tyumen Oblast, Russia
Kemerovo Regional Clinical Hospital
Kemerovo, , Russia
FSBIH Siberian Regional Medical Centre of FMBA of Russia
Novosibirsk, , Russia
MRC for Oncology and Neurology Biotherapy
Novosibirsk, , Russia
Samara State Medical University
Samara, , Russia
Reg. SI of Health Care Smolensk Regional Clinical Hospital
Smolensk, , Russia
Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik"
Tyumen, , Russia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Clinical Center Nis
Niš, , Serbia
FNsP Bratislava - Nemocnica Stare mesto
Bratislava, , Slovakia
FNsP Bratislava, Nemocnica Ruzinov
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava Nemocnica sv. Cyrila a Metoda; Nemocnicna lekaren
Bratislava, , Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, , Slovakia
Dr CC Coetzee Inc
Durban, , South Africa
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
Basel, , Switzerland
Ospedale Regionale Lugano Civico Medizin Neurologie; Neurologia
Lugano, , Switzerland
Hopital Razi
Mannouba, , Tunisia
Hopital Universitaire Fattouma Bourguiba
Monastir, , Tunisia
Hopital Charles Nicolle
Tunis, , Tunisia
MMPIDon.Reg.Cl.&Ter.Med.Com.Neur.Dept.DNMU n.a.M.Gorkiy; Ch. of Nervous Diseases and Med. Genetics
Donetsk, , Ukraine
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis
Kharkiv, , Ukraine
Kyiv City Cl.Hosp.#4 Depart.of Neurology #2NMU; Department of Neurology
Kyiv, , Ukraine
Lviv Regional Clinical Hospital; Department of Neurology
Lviv, , Ukraine
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
Vinnytsia, , Ukraine
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool, , United Kingdom
Royal London Hospital; Neurology
London, , United Kingdom
Countries
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References
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Kappos L, Yiu S, Reucassel J, Oh J, Granziera C, Killestein J, Bermel RA, Berge C, Kazlauskaite A, Schneble HM, Dahlke F, Cree BAC. Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Sep;12(9):1805-1812. doi: 10.1002/acn3.70111. Epub 2025 Jul 8.
Montobbio N, Bovis F, Signori A, Carmisciano L, Schiavetti I, Ponzano M, Tur C, Granziera C, Cagol A, Arnold DL, Kappos L, Sormani MP. Uncovering a bias in estimated treatment effects on PIRA in multiple sclerosis clinical trials. EBioMedicine. 2025 Jul;117:105802. doi: 10.1016/j.ebiom.2025.105802. Epub 2025 Jun 18.
Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.
Benedict RH, Kappos L, Miller A, Hartung HP, Overell J, Pei J, Dahlke F, Bernasconi C, Koendgen H, Wang Q, Bonati U, Cohan S. Cognitive effects of ocrelizumab vs interferon beta-1a in relapsing multiple sclerosis: A post hoc analysis of the OPERA I/II trials. Mult Scler Relat Disord. 2025 Mar;95:106310. doi: 10.1016/j.msard.2025.106310. Epub 2025 Feb 2.
Muros-Le Rouzic E, Heer Y, Yiu S, Tozzi V, Braune S, van Hovell P, Bergmann A, Bernasconi C, Model F, Craveiro L; NTD study group. Five-year efficacy outcomes of ocrelizumab in relapsing multiple sclerosis: A propensity-matched comparison of the OPERA studies with other disease-modifying therapies in real-world lines of treatments. J Cent Nerv Syst Dis. 2024 Sep 13;16:11795735241260563. doi: 10.1177/11795735241260563. eCollection 2024.
Loomis SJ, Sadhu N, Fisher E, Gafson AR, Huang Y, Yang C, Hughes EE, Marshall E, Herman A, John S, Runz H, Jia X, Bhangale T, Bronson PG. Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials. Sci Rep. 2023 Aug 31;13(1):14313. doi: 10.1038/s41598-023-41099-0.
Kolind S, Gaetano L, Assemlal HE, Bernasconi C, Bonati U, Elliott C, Hagenbuch N, Magon S, Arnold DL, Traboulsee A. Ocrelizumab-treated patients with relapsing multiple sclerosis show volume loss rates similar to healthy aging. Mult Scler. 2023 May;29(6):741-747. doi: 10.1177/13524585231162586. Epub 2023 May 6.
Laurent SA, Strauli NB, Eggers EL, Wu H, Michel B, Demuth S, Palanichamy A, Wilson MR, Sirota M, Hernandez RD, Cree BAC, Herman AE, von Budingen HC. Effect of Ocrelizumab on B- and T-Cell Receptor Repertoire Diversity in Patients With Relapsing Multiple Sclerosis From the Randomized Phase III OPERA Trial. Neurol Neuroimmunol Neuroinflamm. 2023 Apr 24;10(4):e200118. doi: 10.1212/NXI.0000000000200118. Print 2023 Jul.
Hauser SL, Bar-Or A, Weber MS, Kletzl H, Gunther A, Manfrini M, Model F, Mercier F, Petry C, Wing Q, Koendgen H, Smith T, Kappos L. Association of Higher Ocrelizumab Exposure With Reduced Disability Progression in Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2023 Feb 15;10(2):e200094. doi: 10.1212/NXI.0000000000200094. Print 2023 Mar.
Falet JR, Durso-Finley J, Nichyporuk B, Schroeter J, Bovis F, Sormani MP, Precup D, Arbel T, Arnold DL. Estimating individual treatment effect on disability progression in multiple sclerosis using deep learning. Nat Commun. 2022 Sep 26;13(1):5645. doi: 10.1038/s41467-022-33269-x.
Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.
Krishnan AP, Song Z, Clayton D, Gaetano L, Jia X, de Crespigny A, Bengtsson T, Carano RAD. Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials. Radiology. 2022 Mar;302(3):662-673. doi: 10.1148/radiol.211528. Epub 2021 Dec 14.
Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.
Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.
Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.
Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-020337-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA21092
Identifier Type: -
Identifier Source: org_study_id
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