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.
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
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There are 183 Locations for this study
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85013, United States
Scottsdale Arizona, 85259, United States
Phoenix Arkansas, 85032, United States
Berkeley California, 94705, United States
Newport Beach California, 92663, United States
Sacramento California, 95817, United States
San Francisco California, 94143, United States
Aurora Colorado, 80045, United States
Miami Florida, 33136, United States
Vero Beach Florida, 32960, United States
Kansas City Kansas, 66160, United States
Prairie Village Kansas, 66206, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Farmington Hills Michigan, 48334, United States
Minneapolis Minnesota, 55414, United States
Saint Louis Missouri, 63110, United States
Teaneck New Jersey, 07666, United States
Albuquerque New Mexico, 87131, United States
Mineola New York, 11501, United States
New York New York, 10021, United States
New York New York, 10029, United States
Patchogue New York, 11772, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28207, United States
Raleigh North Carolina, 27607, United States
Columbus Ohio, 43221, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19104, United States
Providence Rhode Island, 02905, United States
Cordova Tennessee, 38018, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Richmond Virginia, 23229, United States
Seattle Washington, 98122, United States
Hobart Tasmania, 7000, Australia
Fitzroy Victoria, 3065, Australia
Innsbruck , 6020, Austria
Linz , 4020, Austria
Linz , 4021, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
La Louvière , 7100, Belgium
Sijsele , 8340, Belgium
Goiania GO, 74653, Brazil
Belo Horizonte MG, 30150, Brazil
Rio de Janeiro RJ, 21941, Brazil
Porto Alegre RS, 90610, Brazil
Sofia , 1113, Bulgaria
Sofia , 1309, Bulgaria
Calgary Alberta, T2N 2, Canada
Vancouver British Columbia, V6T 1, Canada
Winnipeg Manitoba, R8A 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5B 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3A 2, Canada
Brno , 625 0, Czechia
Praha 2 , 128 0, Czechia
Teplice , 415 2, Czechia
Helsinki , 00290, Finland
Tampere , 33520, Finland
Turku , 20520, Finland
Bordeaux , 33076, France
Bron , 69677, France
Caen , 14033, France
Clermont-Ferrand , 63003, France
Lille , , France
Marseille , 13005, France
Montpellier , 34295, France
Nancy , 54035, France
Nantes , 44805, France
Nice , 06002, France
Nimes , 30029, France
Paris , 75019, France
Paris , 75651, France
Poissy , 78300, France
Reims , 51092, France
Strasbourg , 67091, France
Toulouse , 31059, France
Bayreuth , 95445, Germany
Berg , 82335, Germany
Berlin , 10117, Germany
Berlin , 13347, Germany
Bochum , 44789, Germany
Dresden , 01307, Germany
Düsseldorf , 40225, Germany
Frankfurt am Main , 60528, Germany
Gießen , 35392, Germany
Heidelberg , 69120, Germany
Koln , 51109, Germany
Leipzig , 04103, Germany
Munchen , 81675, Germany
Münster , 48149, Germany
Regensburg , 93053, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Wiesbaden , 65191, Germany
Athens , 115 2, Greece
Thessaloniki , 546 3, Greece
Thessaloniki , 57010, Greece
Budapest , 1145, Hungary
Budapest , 1204, Hungary
Esztergom , 2500, Hungary
Pécs , 7623, Hungary
Szeged , 6725, Hungary
Veszprem , 8200, Hungary
Ashkelon , 78306, Israel
Jerusalem , 91120, Israel
Petach Tikva , 49100, Israel
Ramat-Gan , 52621, Israel
Safed , 13100, Israel
Tel Aviv , 64239, Israel
Genova Liguria, 16132, Italy
Milano Lombardia, 20132, Italy
Orbassano Piemonte, 10043, Italy
Cagliari Sardegna, 09126, Italy
Kaunas , 50009, Lithuania
Klaipeda , 92288, Lithuania
Siauliai , 76231, Lithuania
Ciudad de México Mexico CITY (federal District), 14390, Mexico
Mexico Mexico CITY (federal District), 3600, Mexico
Monterrey Nuevo LEON, 64620, Mexico
Aguascalientes , 20127, Mexico
Rotterdam , 3015 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Hamilton , 3240, New Zealand
Wellington , 6021, New Zealand
Oslo , 0407, Norway
Bellavista , Calla, Peru
Lima , 18, Peru
Lima , Lima , Peru
Bialystok , 15-40, Poland
Jaroslaw , 37-50, Poland
Katowice , 40-59, Poland
Katowice , 40-68, Poland
Konskie , 26-20, Poland
Lodz , 90-15, Poland
Lublin , 20-95, Poland
Almada , 2801-, Portugal
Amadora , 2720-, Portugal
Coimbra , 3000-, Portugal
Coimbra , 3041-, Portugal
Lisboa , 1649-, Portugal
Porto , 4099-, Portugal
Bucharest , 01146, Romania
Campulung , 11510, Romania
Targu Mures , 54013, Romania
Timi?oara , 30059, Romania
Kazan Tatarstan, 42010, Russian Federation
Salt Girona, 17190, Spain
San Sebastian Guipuzcoa, 20014, Spain
Santiago de Compostela LA Coruña, 15706, Spain
Bilbao Vizcaya, 48013, Spain
Alicante , 03010, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
Basel , 4031, Switzerland
Lugano , 6903, Switzerland
Chernivtsi Chernihiv Governorate, 58022, Ukraine
Odesa Kherson Governorate, 65025, Ukraine
Kyiv KIEV Governorate, 04107, Ukraine
Dnipropetrovsk , 49027, Ukraine
Dnipropetrovsk , 49044, Ukraine
Kharkiv , 61176, Ukraine
Kharkov , 61068, Ukraine
Kyiv , 03110, Ukraine
Lutsk , 43024, Ukraine
Lviv , 79010, Ukraine
Vinnytsya , 21018, Ukraine
Liverpool , L9 7L, United Kingdom
London , E1 2E, United Kingdom
London , SE5 9, United Kingdom
Newcastle Upon Tyne , NE1 4, United Kingdom
Nottingham , NG7 2, United Kingdom
Indianapolis , 46202, Uruguay
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