Multiple Sclerosis Clinical Trial

A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

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. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

735

Study ID:

NCT01194570

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 183 Locations for this study

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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, 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
Saint 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, 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, 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
Wien , 1090, Austria
CHU Tivoli
La Louvière , 7100, Belgium
AZ Alma vzw (Sijsele)
Sijsele , 8340, Belgium
Hospital das Clinicas - UFG;Reumatologia
Goiania GO, 74653, Brazil
Santa Casa de Misericordia; de Belo Horizonte
Belo Horizonte MG, 30150, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro RJ, 21941, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, 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 2, Canada
University of British Columbia UBC Hospital; Multiple Sclerosis (MS) Clinic - Vancouver
Vancouver British Columbia, V6T 1, Canada
Health Sciences Centre
Winnipeg Manitoba, R8A 1, Canada
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
St. Michael'S Hospital
Toronto Ontario, M5B 1, Canada
Recherche Sepmus Inc.
Greenfield Park Quebec, J4V 2, Canada
Montreal Neurological Institute and Hospital
Montreal Quebec, H3A 2, Canada
Fakultni nemocnice Brno; Interni kardiologicka klinika
Brno , 625 0, Czechia
Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
Praha 2 , 128 0, Czechia
Krajska zdravotni, a. s. ? Nemocnice Teplice, o. z.; Neurologicke oddeleni
Teplice , 415 2, 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
Nimes , 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
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
Kliniken der Stadt Koln gGmbH
Koln , 51109, Germany
Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
Leipzig , 04103, Germany
Klinikum rechts der Isar der Technischen Universität München
Munchen , 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 2, Greece
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
Thessaloniki , 546 3, 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
Veszprem , 8200, Hungary
Barzilai Medical Center; Neurology Department
Ashkelon , 78306, Israel
Hadassah University Hospital Ein Kerem; Neurology Department
Jerusalem , 91120, Israel
Rabin Medical Center; Multiple Sclerosis Clinic
Petach Tikva , 49100, Israel
The Chaim Sheba Medical Center; Multiple Sclerosis Center
Ramat-Gan , 52621, Israel
Medical Center Ziv Safed; Neurology Department
Safed , 13100, Israel
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv , 64239, Israel
A.O. Universitaria S. Martino Di Genova
Genova Liguria, 16132, Italy
Hospital San Raffaele
Milano Lombardia, 20132, Italy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
Orbassano Piemonte, 10043, Italy
Ospedale Binaghi; Centro Sclerosi Multipla
Cagliari Sardegna, 09126, Italy
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas , 50009, Lithuania
Klaipeda University Hospital Public Institution
Klaipeda , 92288, Lithuania
Siauliai Hospital
Siauliai , 76231, Lithuania
Instituto Nacional de Neurologia y Neurocirugia
Ciudad de México Mexico CITY (federal District), 14390, Mexico
Eleccion Salud SC
Mexico Mexico CITY (federal District), 3600, Mexico
Centro de Estudios Clinicos y Espec. Med. SC
Monterrey Nuevo LEON, 64620, Mexico
Instituto Biomedico De Investigacion A.C.
Aguascalientes , 20127, Mexico
Erasmus MC; Afdeling Neurologie
Rotterdam , 3015 , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen , 6162 , 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 , Calla, Peru
Clinica Anglo Americana
Lima , 18, Peru
Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología
Lima , Lima , Peru
Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna
Bialystok , 15-40, Poland
Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna
Jaroslaw , 37-50, Poland
Diagnomed Clinical Research Sp. z o.o.
Katowice , 40-59, Poland
Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic
Katowice , 40-68, Poland
Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny
Konskie , 26-20, Poland
SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii
Lodz , 90-15, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi
Lublin , 20-95, Poland
Hospital Garcia de Orta; Servico de Neurologia
Almada , 2801-, Portugal
Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Amadora , 2720-, Portugal
HUC; Servico de Neurologia
Coimbra , 3000-, Portugal
Hospital Geral; Servico de Neurologia
Coimbra , 3041-, Portugal
Hospital de Santa Maria; Servico de Neurologia
Lisboa , 1649-, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto , 4099-, Portugal
Elias Emergency University Hospital Neurology Dept; Neurology Department
Bucharest , 01146, Romania
SC Clubul Sanatatii SRL
Campulung , 11510, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Targu Mures , 54013, Romania
Timisoara Emergency County Clinical Hospital
Timi?oara , 30059, Romania
Research Medical Complex "Vashe Zdorovie"; Neurology Department
Kazan Tatarstan, 42010, Russian Federation
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
Salt Girona, 17190, Spain
Hospital 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
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla , 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
Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology
Kharkiv , 61176, Ukraine
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkov , 61068, 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
Vinnytsya , 21018, Ukraine
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool , L9 7L, United Kingdom
Barts and the London NHS Trust
London , E1 2E, United Kingdom
Kings College Hospital; Neurology
London , SE5 9, United Kingdom
Royal Victoria Infirmary; Neurology Dept.
Newcastle Upon Tyne , NE1 4, United Kingdom
Uni Hospital Queens Medical Centre; Neurology
Nottingham , NG7 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

735

Study ID:

NCT01194570

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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