A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
2 other identifiers
interventional
835
23 countries
164
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
Longer than P75 for phase_3
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
August 9, 2011
CompletedStudy Start
First participant enrolled
September 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2015
CompletedResults Posted
Study results publicly available
July 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMarch 8, 2024
March 1, 2024
3.6 years
August 8, 2011
March 30, 2017
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
Week 96
Secondary Outcomes (13)
Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period
Week 104
Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment
Baseline up to week 96
Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment
Baseline up to week 96
Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks In Double Blind Period
Week 96
Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period
Week 104
- +8 more secondary outcomes
Study Arms (2)
Interferon beta-1a 44 mcg SC
ACTIVE COMPARATORInterferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).
Ocrelizumab
EXPERIMENTALOcrelizumab 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (165)
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, 48109-0666, 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, 27607-6520, 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, 75390-0001, 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, C1425BWO, Argentina
STAT Research S.A.
Ciudad de Buenos Airesa, C1013AAB, Argentina
Grodno State Medical University
Hrodna, Grodnenskaya, 230017, Belarus
Vitebsk; Regional Diagnostic Center
Vitebsk, Vitebsk Oblast, 210023, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, Vitebsk Oblast, 210037, Belarus
City Clinical Hospital #9
Minsk, 220116, Belarus
UZ Antwerpen
Edegem, 2650, Belgium
University Clinic Ctr Sarajevo
Sarajevo, 71 000, Bosnia and Herzegovina
Uni Hospital Center Tuzla
Tuzla, 75000, Bosnia and Herzegovina
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Hospital Universitario Gaffree e Guinle
Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-887, 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 2T9, Canada
University of Alberta; Northern Alberta Trials & Research Centre
Edmonton, Alberta, T6G 2C8, Canada
Vancouver Hospital - UBC Hospital Site
Vancouver, British Columbia, V6Z 1Y6, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Clinique NeuroOutaouais
Gatineau, Quebec, J8Y 1W2, Canada
Recherche Sepmus Inc.
Greenfield Park, Quebec, J4V 2J2, Canada
Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie
Montreal, Quebec, H1T 2M4, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
General Hospital Pula
Pula, 52100, Croatia
General Hospital Varazdin
Varaždin, 42000, Croatia
Clinical Hospital Centre Zagreb;Clinic for Neurology
Zagreb, 10000, Croatia
Uni Hospital Centre Dubrava
Zagreb, 10000, Croatia
Fakultni nemocnice Brno
Brno, 613 00, Czechia
Neurospol s.r.o.
Havířov, 736 00, Czechia
Pardubicka Krajska Nemocnice; Department of Neurology
Pardubice, 532 03, Czechia
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice, 415 29, Czechia
Hopital Neurologique Pierre Wertheimer
Bron, 69500, France
Hôpital General - Service de neurologie; Service de neurologie
Dijon, 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
München, 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, Ireland
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Apulia, 70021, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Apulia, 71013, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168, Italy
A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, 16132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna
Milan, Lombardy, 20133, Italy
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari, Lombardy, 25018, Italy
Ospedale degli Infermi
Ponderano, Piedmont, 13875, Italy
Fond. Ist. S. Raffaele - giglio
Cefalù, Sicily, 90015, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Torrette - Ancona, The Marches, 60100, Italy
Hospital Mexico Americano SC; Departamento de Electroencefalografía
Guadalajara, Jalisco, 44620, Mexico
Mexico Centre for Clinical Research
Mexico City, Mexico CITY (federal District), 03100, Mexico
Clinical Research Institute
Tlalnepantla, Mexico CITY (federal District), 54055, Mexico
Hospital Angeles Culiacan; Neurociencias
Culiacán, Sinaloa, 80020, Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes, 20127, Mexico
Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4
Chihuahua City, 31238, Mexico
Haukeland Universitetssykehus
Bergen, 5053, Norway
Vitamed
Bydgoszcz, 85-021, Poland
MA-LEK Clinical Sp. Z o.o.
Katowice, 40-595, Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, 31-505, Poland
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
Lodz, 90-153, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, 90-324, Poland
Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie
Lublin, 20-954, Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym
Olsztyn, 10-561, Poland
Neuro-Care Gabriela Klodowska
Siemianowice ?l?skie, 41-100, Poland
mMED Maciej Czarnecki
Warsaw, 01-684, Poland
State institution of health care - Territorial Clinical Hospital
Barnaul, Altayskiy Kray, 656024, Russia
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Saint Petersburg, Sankt-Peterburg, 197022, Russia
City Clinical Hospital#2
Pyatigorsk, Stavropol Kray, 357538, Russia
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan', Tatarstan Republic, 420101, Russia
Kirov City Clinical Hospital #1; Neurology Department
Kirov, 610014, Russia
SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department
Nizniy Novgorod, 603155, Russia
Perm SMA n.a. academ. E.A. Vagner
Perm, 614990, Russia
Saratov State Medical University of RosZdrav; Neurology
Saratov, 410012, Russia
MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
Banská Bystrica, 974 04, Slovakia
Fakultna Nemocnica Roosevelta
Banská Bystrica, 975 17, Slovakia
Vseobecna nemocnica s poliklinikou Levoca a.s.
Levoča, 054 01, 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
Málaga, 29010, Spain
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
Valencia, 46010, Spain
Sahlgrenska Sjukhuset; Neurology
Gothenburg, 413 45, Sweden
Karolinska Universitetssjukhuset Solna Neurology
Stockholm, 113 41, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, 171 64, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Hacettepe University Medical Faculty; Neurology
Ankara, 06100, Turkey (Türkiye)
Haseki Training and Research Hospital
Istanbul, 34096, Turkey (Türkiye)
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
Istanbul, 34098, Turkey (Türkiye)
Istanbul Bilim Universty Medical Fac.
Istanbul, 34394, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, 55139, Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon, 61080, Turkey (Türkiye)
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 5DW, United Kingdom
Kings College Hospital; Neurosciences Clinical Trials Office
London, SE5 9NT, United Kingdom
City General Hospital; Department of Neurology
Stoke-on-Trent, ST4 6QG, United Kingdom
Morriston Hospital
Swansea, SA6 6NL, United Kingdom
Related Publications (15)
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.
PMID: 40629721DERIVEDMontobbio 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.
PMID: 40554392DERIVEDKappos 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.
PMID: 40258203DERIVEDBenedict 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.
PMID: 39965438DERIVEDMuros-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.
PMID: 39290861DERIVEDLoomis 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.
PMID: 37652990DERIVEDKolind 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.
PMID: 37148240DERIVEDHauser 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.
PMID: 36792367DERIVEDFalet 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.
PMID: 36163349DERIVEDArnold 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.
PMID: 35672926DERIVEDKrishnan 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.
PMID: 34904871DERIVEDGiovannoni 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.
PMID: 33724637DERIVEDHauser 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.
PMID: 32690791DERIVEDKappos 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.
PMID: 32511687DERIVEDHauser 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.
PMID: 28002679DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2011
First Posted
August 9, 2011
Study Start
September 20, 2011
Primary Completion
May 12, 2015
Study Completion
December 30, 2022
Last Updated
March 8, 2024
Results First Posted
July 18, 2017
Record last verified: 2024-03