A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
2 other identifiers
interventional
735
28 countries
179
Brief Summary
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
Longer than P75 for phase_3
179 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 28, 2010
CompletedFirst Posted
Study publicly available on registry
September 3, 2010
CompletedStudy Start
First participant enrolled
March 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2015
CompletedResults Posted
Study results publicly available
December 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJanuary 10, 2024
December 1, 2023
4.4 years
August 28, 2010
March 30, 2017
December 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit \>=12 weeks (\>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of \>= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is \<=5.5 points (inclusive), or an increase of \>=0.5 points, if baseline EDSS is \>5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.
Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Secondary Outcomes (6)
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period
Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120
Baseline, Week 120
Percent Change From Baseline in Total Volume of T2 Lesions at Week 120
From Baseline to Week 120
Percent Change in Total Brain Volume From Week 24 to Week 120
From Week 24 to Week 120
Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120
From Baseline to Week 120
- +1 more secondary outcomes
Study Arms (2)
Placebo
EXPERIMENTALParticipants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
Ocrelizumab 600 mg
PLACEBO COMPARATORParticipants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
Interventions
Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.
Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
Eligibility Criteria
You may qualify if:
- Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)
- EDSS at screening from 3 to 6.5 points
- Disease duration from onset of MS symptoms less than (\<) 15 years if EDSS greater than (\>) 5.0; \<10 years if EDSS greater than or equal to (\>/=) 5.0
- Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
You may not qualify if:
- History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening
- Inability to complete an MRI (contraindications for MRI)
- Known presence of other neurologic disorders
- Known active infection or history of or presence of recurrent or chronic infection
- History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
- Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
- Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (184)
Phoenix Neurological Associates Ltd
Phoenix, Arizona, 85006, United States
Barrow Neurology Clinic
Phoenix, Arizona, 85013, United States
Mayo Clinic- Scottsdale
Scottsdale, Arizona, 85259, United States
Arizona Neuroscience Research LLC
Phoenix, Arkansas, 85032-2181, United States
Sutter East Bay Medical Foundation
Berkeley, California, 94705, United States
MS Center of Southern California
Newport Beach, California, 92663, United States
Univ of CA Davis Med Ctr; Neurology
Sacramento, California, 95817, United States
Univ of CA San Francisco; Department of Neurology
San Francisco, California, 94143, United States
University of Colorado; Anschutz Medical Campus Department of Neurology
Aurora, Colorado, 80045, United States
University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center
Miami, Florida, 33136, United States
Vero Beach Neurology and Research Institute
Vero Beach, Florida, 32960, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MidAmerica Neuroscience Institute
Prairie Village, Kansas, 66206, United States
Wayne State University; Department of Neurology
Detroit, Michigan, 48201, United States
Henry Ford Health System; Neurology & Neurosurgery
Detroit, Michigan, 48202, United States
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334, United States
University of Minnesota; Clin. Neuro Research Unit
Minneapolis, Minnesota, 55414, United States
Washington University School of Medicine; Department of Neurology
St Louis, Missouri, 63110, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
University of New Mexico; MS Specialty Clinic
Albuquerque, New Mexico, 87131, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Weill Medical College of Cornell University; Judith Jaffe MS Ctr
New York, New York, 10021, United States
Mount Sinai School of Medicine; Neurology
New York, New York, 10029, United States
Comprehensive MS Care Center at South Shore Neurologic Assoc.
Patchogue, New York, 11772, United States
Neurology Assoc of Stony Brook
Stony Brook, New York, 11794, United States
Carolinas Medical Center; Ms Center
Charlotte, North Carolina, 28207, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607-6520, United States
The Ohio State University Wexner Medical Center; Department of Neurology
Columbus, Ohio, 43221, United States
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City, Oklahoma, 73104, United States
Trustees of the University of Pennsylvania; Neurology
Philadelphia, Pennsylvania, 19104, United States
The Neurology Foundation, Inc.
Providence, Rhode Island, 02905, United States
Neurology Clinic PC
Cordova, Tennessee, 38018, United States
University of Texas Southwestern
Dallas, Texas, 75390-8897, United States
Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology
Houston, Texas, 77030, United States
Neurological Associates, Inc.
Richmond, Virginia, 23229, United States
Swedish Neuroscience Institute; Multiple Sclerosis Center
Seattle, Washington, 98122, United States
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research
Fitzroy, Victoria, 3065, Australia
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
Innsbruck, 6020, Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
Linz, 4020, Austria
Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie
Linz, 4021, Austria
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
Salzburg, 5020, Austria
Medizinische Universitat Wien Medical University of Vienna
Vienna, 1090, Austria
CHU Tivoli
La Louvière, 7100, Belgium
AZ Alma vzw (Sijsele)
Sijsele, 8340, Belgium
Hospital das Clinicas - UFG;Reumatologia
Goiânia, Goiás, 74653-050, Brazil
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Shat Np Sveti Naum; 3Rd Clinic of Neurology
Sofia, 1113, Bulgaria
Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
Sofia, 1309, Bulgaria
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
University of British Columbia UBC Hospital; Multiple Sclerosis (MS) Clinic - Vancouver
Vancouver, British Columbia, V6T 1Z3, Canada
Health Sciences Centre
Winnipeg, Manitoba, R8A 1R9, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
St. Michael'S Hospital
Toronto, Ontario, M5B 1W8, Canada
Recherche Sepmus Inc.
Greenfield Park, Quebec, J4V 2J2, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
Fakultni nemocnice Brno; Interni kardiologicka klinika
Brno, 625 00, Czechia
Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
Prague, 128 08, Czechia
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice, 415 29, Czechia
Helsingin yliopistollinen keskussairaala
Helsinki, 00290, Finland
Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö
Tampere, 33520, Finland
Turku University Central Hospital; Pharmacy
Turku, 20520, Finland
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
Bordeaux, 33076, France
Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
Bron, 69677, France
Hopital Cote De Nacre; Unite Neurologie Generale
Caen, 14033, France
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, 63003, France
Hopital Roger Salengro Service de Neurologie
Lille, France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, 13005, France
Hopital Gui de Chauliac; Neurologie
Montpellier, 34295, France
CHRU Nancy; Service de neurologie
Nancy, 54035, France
Hôpital Guillaume et René Laënnec; Service Neurologie
Nantes, 44805, France
Hôpital Pasteur; Service de Neurologie
Nice, 06002, France
Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
Nîmes, 30029, France
Fondation Rothschild; Service de Neurologie
Paris, 75019, France
Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
Paris, 75651, France
Hôpital de Poissy; Service neurologie
Poissy, 78300, France
Hôpital Maison Blanche; Service de Neurologie
Reims, 51092, France
Chu De Strasbourg; Hopital Civil
Strasbourg, 67091, France
Hopital Purpan; Fédération de neurologie
Toulouse, 31059, France
Klinikum Bayreuth GmbH; Neurologische Klinik
Bayreuth, 95445, Germany
Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
Berg, 82335, Germany
Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
Berlin, 10117, Germany
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin, 13347, Germany
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
Bochum, 44789, Germany
Kliniken der Stadt Koln gGmbH
Cologne, 51109, Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie
Dresden, 01307, Germany
Heinrich Heine Universität Düsseldorf; Neurologische Klinik
Düsseldorf, 40225, Germany
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
Frankfurt am Main, 60528, Germany
Universitätsklinikum Gießen und Marburg GmbH; Neurologie
Giessen, 35392, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
Leipzig, 04103, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie
Regensburg, 93053, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076, Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm, 89081, Germany
DKD Helios Klinik (Deutsche Klinik für Diagnostik GmbH)
Wiesbaden, 65191, Germany
401 Military Hospital of Athens; Neurology Department
Athens, 115 25, Greece
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
Thessaloniki, 546 36, Greece
Georgios Papanikolaou General Hosp. of Thessaloniki
Thessaloniki, 57010, Greece
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, 1145, Hungary
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
Budapest, 1204, Hungary
Vaszary Kolos Korhaz; Neurology
Esztergom, 2500, Hungary
Pécsi Tudományegyetem
Pécs, 7623, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
Szeged, 6725, Hungary
Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia
Veszprém, 8200, Hungary
Barzilai Medical Center; Neurology Department
Ashkelon, 7830604, Israel
Hadassah University Hospital Ein Kerem; Neurology Department
Jerusalem, 9112001, Israel
Rabin Medical Center; Multiple Sclerosis Clinic
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat Gan, 5262100, Israel
Medical Center Ziv Safed; Neurology Department
Safed, 13100, Israel
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv, 6423906, Israel
A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, 16132, Italy
Hospital San Raffaele
Milan, Lombardy, 20132, Italy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
Orbassano, Piedmont, 10043, Italy
Ospedale Binaghi; Centro Sclerosi Multipla
Cagliari, Sardinia, 09126, Italy
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Klaipeda University Hospital Public Institution
Klaipėda, 92288, Lithuania
Siauliai Hospital
Šiauliai, 76231, Lithuania
Instituto Nacional de Neurologia y Neurocirugia
Mexico City, Mexico CITY (federal District), 14390, Mexico
Eleccion Salud SC
México, Mexico CITY (federal District), 3600, Mexico
Centro de Estudios Clinicos y Espec. Med. SC
Monterrey, Nuevo León, 64620, Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes, 20127, Mexico
Erasmus MC; Afdeling Neurologie
Rotterdam, 3015 GD, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, 6162 BG, Netherlands
Waikato Hospital; Neurology
Hamilton, 3240, New Zealand
Wellington Hospital; Department of Neurology
Wellington, 6021, New Zealand
Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling
Oslo, 0407, Norway
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
Bellavista, Callao 2, Peru
Clinica Anglo Americana
Lima, 18, Peru
Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología
Lima, Lima 1, Peru
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna
Bialystok, 15-402, Poland
Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny
Gmina Końskie, 26-200, Poland
Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna
Jarosław, 37-500, Poland
Diagnomed Clinical Research Sp. z o.o.
Katowice, 40-594, Poland
Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic
Katowice, 40-686, Poland
SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii
Lodz, 90-153, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
Lublin, 20-954, Poland
Hospital Garcia de Orta; Servico de Neurologia
Almada, 2801-951, Portugal
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Amadora, 2720-276, Portugal
HUC; Servico de Neurologia
Coimbra, 3000-075, Portugal
Hospital Geral; Servico de Neurologia
Coimbra, 3041-801, Portugal
Hospital de Santa Maria; Servico de Neurologia
Lisbon, 1649-035, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, 4099-001, Portugal
Elias Emergency University Hospital Neurology Dept; Neurology Department
Bucharest, 011461, Romania
SC Clubul Sanatatii SRL
Campulung Muscel, 115100, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Târgu Mureş, 540136, Romania
Timisoara Emergency County Clinical Hospital
Timi?oara, 300595, Romania
Research Medical Complex "Vashe Zdorovie"; Neurology Department
Kazan', Tatarstan Republic, 420103, Russia
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
Salt, Girona, 17190, Spain
Hospital Donostia
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital de Basurto Servicio de Neurologia
Bilbao, Vizcaya, 48013, Spain
Hospital General Univ. de Alicante
Alicante, 03010, Spain
Hospital del Mar; Servicio de Neurologia
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona, 08035, Spain
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, 08041, Spain
Universitario de La Princesa; Servicio de Neurología
Madrid, 28006, Spain
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Neurología
Madrid, 28040, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Seville, 41009, Spain
Universitätsspital Basel; Neurologie
Basel, 4031, Switzerland
Ospedale Regionale di Lugano - Civico; Neurologia
Lugano, 6903, Switzerland
CNPE City Clinical Hospital #3 of Chernivtsi City Council
Chernivtsi, Chernihiv Governorate, 58022, Ukraine
Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
Odesa, Kherson Governorate, 65025, Ukraine
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, KIEV Governorate, 04107, Ukraine
Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro
Dnipropetrovsk, 49027, Ukraine
Dnipropetrovsk State Medical Academy; Dept of Neurology
Dnipropetrovsk, 49044, Ukraine
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkiv, 61068, Ukraine
Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology
Kharkiv, 61176, Ukraine
Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology
Kyiv, 03110, Ukraine
Volyn Regional Clinical Hospital
Lutsk, 43024, Ukraine
Lviv Regional Clinical Hospital; Department of Neurology
Lviv, 79010, Ukraine
Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3
Vinnytsia, 21018, Ukraine
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool, L9 7LJ, United Kingdom
Barts and the London NHS Trust
London, E1 2ES, United Kingdom
Kings College Hospital; Neurology
London, SE5 9RS, United Kingdom
Royal Victoria Infirmary; Neurology Dept.
Newcastle upon Tyne, NE1 4LP, United Kingdom
Uni Hospital Queens Medical Centre; Neurology
Nottingham, NG7 2UH, United Kingdom
Related Publications (11)
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.
PMID: 40258203DERIVEDZivadinov R, Pei J, Clayton D, Goldman DE, Winger RC, Cabatingan MS, Dwyer MG, Bergsland N. Evolution of atrophied T2 lesion volume in primary-progressive multiple sclerosis: results from the phase 3 ORATORIO study. J Neurol Neurosurg Psychiatry. 2024 May 14;95(6):536-543. doi: 10.1136/jnnp-2023-332573.
PMID: 38071574DERIVEDLoomis 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: 37652990DERIVEDHauser 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: 35672926DERIVEDButzkueven H, Spelman T, Horakova D, Hughes S, Solaro C, Izquierdo G, Kubala Havrdova E, Grand'Maison F, Prat A, Girard M, Hupperts R, Onofrj M, Lugaresi A, Taylor B; MSBase Study Group; Giovannoni G, Kappos L, Hauser SL, Montalban X, Craveiro L, Freitas R, Model F, Overell J, Muros-Le Rouzic E, Sauter A, Wang Q, Wormser D, Wolinsky JS. Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry. Eur J Neurol. 2022 Apr;29(4):1082-1090. doi: 10.1111/ene.14824. Epub 2021 May 6.
PMID: 33724638DERIVEDWolinsky JS, Arnold DL, Brochet B, Hartung HP, Montalban X, Naismith RT, Manfrini M, Overell J, Koendgen H, Sauter A, Bennett I, Hubeaux S, Kappos L, Hauser SL. Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):998-1009. doi: 10.1016/S1474-4422(20)30342-2. Epub 2020 Oct 29.
PMID: 33129442DERIVEDFox EJ, Markowitz C, Applebee A, Montalban X, Wolinsky JS, Belachew S, Fiore D, Pei J, Musch B, Giovannoni G. Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial. Mult Scler. 2018 Dec;24(14):1862-1870. doi: 10.1177/1352458518808189. Epub 2018 Nov 12.
PMID: 30415593DERIVEDWolinsky JS, Montalban X, Hauser SL, Giovannoni G, Vermersch P, Bernasconi C, Deol-Bhullar G, Garren H, Chin P, Belachew S, Kappos L. Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial. Ann Neurol. 2018 Oct;84(4):527-536. doi: 10.1002/ana.25313.
PMID: 30155979DERIVEDMontalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.
PMID: 28002688DERIVED
MeSH Terms
Conditions
Interventions
Condition 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2010
First Posted
September 3, 2010
Study Start
March 2, 2011
Primary Completion
July 23, 2015
Study Completion
December 31, 2022
Last Updated
January 10, 2024
Results First Posted
December 26, 2017
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).