Multiple Sclerosis Clinical Trial
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Summary
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.
The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.
Eligibility Criteria
Inclusion Criteria:
Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
Have a length of disease duration, from first documented clinical attack consistent with MS disease of less than or equal to (=) 3 years
Within the last 12 months one or more clinically reported relapse(s) or one or more signs of MRI activity
EDSS of 0.0 to 3.5 inclusive, at screening
An agreement to use an acceptable birth control method for women of childbearing potential, during the treatment period and for at least 6 months or longer after the last dose of study drug
Exclusion Criteria:
Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
Inability to complete an MRI
Known presence of other neurological disorders
Exclusions Related to General Health:
Pregnancy or lactation
Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
History or currently active primary or secondary immunodeficiency
Lack of peripheral venous access
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study
Congestive heart failure (New York Heart Association III or IV functional severity)
Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
History of malignancy, major opportunistic infections, alcohol or drug abuse, recurrent or chronic infection, and/or coagulation disorders
Exclusions Related to Medications:
Received any prior approved disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone marrow transplantation)
Treatment with investigational DMT
Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to screening
Exclusion related to Shorter Infusion Substudy:
- Any previous serious IRRs experienced with ocrelizumab treatment
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There are 191 Locations for this study
Irvine California, 92697, United States
Sunnyvale California, 94086, United States
Aurora Colorado, 80045, United States
Fort Collins Colorado, 80528, United States
Stamford Connecticut, 06905, United States
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30309, United States
Overland Park Kansas, 66212, United States
Baton Rouge Louisiana, 70810, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21201, United States
Foxboro Massachusetts, 02035, United States
Wellesley Massachusetts, 02481, United States
Golden Valley Minnesota, 55422, United States
Las Vegas Nevada, 89106, United States
New York New York, 10032, United States
Plainview New York, 11803, United States
Hickory North Carolina, 28602, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44195, United States
Dayton Ohio, 45417, United States
Nashville Tennessee, 37212, United States
Bedford Texas, 76021, United States
Tacoma Washington, 98405, United States
Milwaukee Wisconsin, 53215, United States
Buenos Aires , C1424, Argentina
Buenos Aires , C1437, Argentina
Rosario , S2000, Argentina
Camperdown New South Wales, 2050, Australia
Liverpool New South Wales, 2170, Australia
New Lambton New South Wales, 2305, Australia
St Leonards New South Wales, 2065, Australia
Woolloongabba Queensland, 4102, Australia
Box Hill Victoria, 3128, Australia
Heidelberg Victoria, 3084, Australia
Parkville Victoria, 3050, Australia
Nedlands Western Australia, 6009, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Brugge , 8000, Belgium
Brussel , 1090, Belgium
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
La Louvière , 7100, Belgium
Liège , 4000, Belgium
Overpelt , 3900, Belgium
Belo Horizonte MG, 31270, Brazil
Curitiba PR, 81210, Brazil
Porto Alegre RS, 90610, Brazil
Sao Paulo SP, 05403, Brazil
Sofia , 1113, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1431, Bulgaria
Vancouver British Columbia, V6T 1, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1Y 4, Canada
Toronto Ontario, M4N 3, Canada
Gatineau Quebec, J8Y 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3A 2, Canada
Zagreb , 10000, Croatia
Aalborg , 9000, Denmark
Aarhus N , 8200, Denmark
Glostrup , 2600, Denmark
Besançon , 25030, France
Bordeaux , 33076, France
Bron , 69677, France
Caen , 14033, France
Clermont Ferrand , 63003, France
Gonesse , 95503, France
La Tronche , 38700, France
Montpellier , 34295, France
Nancy , 54035, France
Nantes , 44805, France
Nice , 06002, France
Nimes , 30900, France
Poissy , 78300, France
Rennes , 35033, France
Rouen , 76031, France
Strasbourg , 67098, France
Suresnes , 92151, France
Toulon , 83041, France
Toulouse , 31059, France
Tours , 37000, France
Barsinghausen , 30890, Germany
Berlin , 13347, Germany
Bochum , 44791, Germany
Böblingen , 71034, Germany
Dresden , 01307, Germany
Düsseldorf , 40225, Germany
Erbach/Odenwald , 64711, Germany
Essen , 45147, Germany
Hamburg , 22179, Germany
Heidelberg , 69120, Germany
Kassel , 34121, Germany
Kiel , 24105, Germany
Marburg , 35043, Germany
München , 81675, Germany
Münster , 48149, Germany
Neuburg , 86633, Germany
Seesen , 38723, Germany
Tübingen , 72076, Germany
Budapest , 1083, Hungary
Budapest , 1145, Hungary
Budapest , 1204, Hungary
Esztergom , 2500, Hungary
Szeged , 6725, Hungary
Catanzaro Calabria, 88100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Trieste Friuli-Venezia Giulia, 34149, Italy
Roma Lazio, 00133, Italy
Roma Lazio, 00189, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Montichiari Lombardia, 25018, Italy
Pozzilli Molise, 86077, Italy
Catania Sicilia, 95123, Italy
Palermo Sicilia, 90146, Italy
Firenze Toscana, 50134, Italy
Grosseto Toscana, 58100, Italy
Siena Toscana, 53100, Italy
Kuwait , 10002, Kuwait
Beirut , 1107 , Lebanon
Culiacán Sinaloa, 80020, Mexico
Mexico Tlaxcala, 06726, Mexico
Ciudad de México , 14050, Mexico
'S Hertogenbosch , 5223 , Netherlands
Amsterdam , 1081 , Netherlands
Gouda , 2803 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Lørenskog , 1478, Norway
Stavanger , 4011, Norway
Bydgoszcz , 85-79, Poland
Gdansk , 80-80, Poland
Katowice , 40-56, Poland
Krakow , 31-63, Poland
Lodz , 90-32, Poland
Lublin , 20-01, Poland
Warszawa , 02-09, Poland
Warszawa , 02-95, Poland
Almada , 2801-, Portugal
Braga , 4710-, Portugal
Coimbra , 3000-, Portugal
Loures , 2674-, Portugal
Porto , 4099-, Portugal
Bucharest , 11172, Romania
Sibiu , 55024, Romania
Targu-Mures , 54013, Romania
Bratislava , 813 6, Slovakia
Bratislava , 826 0, Slovakia
Nitra , 949 1, Slovakia
Trnava , 917 7, Slovakia
Ljubljana , 1000, Slovenia
Maribor , 2000, Slovenia
Santa Cruz De Tenerife Tenerife, 38010, Spain
Barakaldo Vizcaya, 48903, Spain
Alicante , 03010, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Madrid , 28222, Spain
Murcia , 30008, Spain
Göteborg , 413 4, Sweden
Karlstad , 651 8, Sweden
Stockholm , 113 4, Sweden
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Lugano , 6903, Switzerland
Luzern , 6004, Switzerland
St. Gallen , 9007, Switzerland
Ankara , 06100, Turkey
Ankara , 06500, Turkey
Hatay , 31001, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Istanbul , 34394, Turkey
Istanbul , 42131, Turkey
Samsun , 55139, Turkey
Trabzon , 61080, Turkey
Cambridge , CB2 0, United Kingdom
Glasgow , G51 4, United Kingdom
London , NW3 2, United Kingdom
London , SE5 9, United Kingdom
London , W6 8R, United Kingdom
London , WC1 3, United Kingdom
Newcastle upon Tyne , NE1 4, United Kingdom
Plymouth , PL6 8, United Kingdom
Salford , M6 8H, United Kingdom
Swansea , SA6 6, United Kingdom
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