Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Launched by HOFFMANN-LA ROCHE · Mar 16, 2017
Trial Information
Current as of September 06, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Liverpool, New South Wales, Australia
Gouda, , Netherlands
Washington, District Of Columbia, United States
Rennes, , France
Winston Salem, North Carolina, United States
Nashville, Tennessee, United States
Stony Brook, New York, United States
London, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
London, , United Kingdom
Irvine, California, United States
Woolloongabba, Queensland, Australia
Aurora, Colorado, United States
Bruxelles, , Belgium
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Fort Collins, Colorado, United States
Plymouth, , United Kingdom
Porto Alegre, Rs, Brazil
Philadelphia, Pennsylvania, United States
New Lambton, New South Wales, Australia
London, , United Kingdom
Golden Valley, Minnesota, United States
Ottawa, Ontario, Canada
Bergen, , Norway
Heidelberg, , Germany
Sibiu, , Romania
La Louvière, , Belgium
Brugge, , Belgium
Edegem, , Belgium
Brussel, , Belgium
Scarborough, Maine, United States
Strasbourg, , France
Zagreb, , Croatia
Budapest, , Hungary
Liège, , Belgium
Plainview, New York, United States
Aarhus N, , Denmark
Bordeaux, , France
Berlin, , Germany
Basel, , Switzerland
Swansea, , United Kingdom
Salford, , United Kingdom
Tucson, Arizona, United States
Trnava, , Slovakia
Cambridge, , United Kingdom
Dayton, Ohio, United States
'S Hertogenbosch, , Netherlands
Bari, Puglia, Italy
Cordova, Tennessee, United States
Innsbruck, , Austria
Salzburg, , Austria
Sofia, , Bulgaria
Sofia, , Bulgaria
Greenfield Park, Quebec, Canada
Marseille, , France
Montpellier, , France
Nantes, , France
Nice, , France
Poissy, , France
Reims, , France
Tübingen, , Germany
Ulm, , Germany
Szeged, , Hungary
Cagliari, Sardegna, Italy
Sittard Geleen, , Netherlands
Almada, , Portugal
Amadora, , Portugal
Coimbra, , Portugal
Porto, , Portugal
Barcelona, , Spain
Lugano, , Switzerland
Rouen, , France
Barakaldo, Vizcaya, Spain
Maribor, , Slovenia
Maitland, Florida, United States
Atlanta, Georgia, United States
Rosario, , Argentina
St Leonards, New South Wales, Australia
Clermont Ferrand, , France
Nimes, , France
Westerstede, , Germany
Budapest, , Hungary
Padova, Veneto, Italy
Gdansk, , Poland
Braga, , Portugal
Santa Cruz De Tenerife, Tenerife, Spain
Madrid, , Spain
Torquay, , United Kingdom
Las Vegas, Nevada, United States
Wellesley, Massachusetts, United States
Sofia, , Bulgaria
Gatineau, Quebec, Canada
Dijon Cedex, , France
Toulouse, , France
Düsseldorf, , Germany
München, , Germany
Montichiari, Lombardia, Italy
Lodz, , Poland
Göteborg, , Sweden
Ankara, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Samsun, , Turkey
Trabzon, , Turkey
Middlesborough, , United Kingdom
Beirut, , Lebanon
Stavanger, , Norway
Greenfield Park, Quebec, Canada
Kuopio, , Finland
Graz, , Austria
Glasgow, , United Kingdom
Bochum, , Germany
Budapest, , Hungary
Tacoma, Washington, United States
Izmir, , Turkey
Milwaukee, Wisconsin, United States
Caen, , France
Sao Paulo, Sp, Brazil
Baton Rouge, Louisiana, United States
Belo Horizonte, Mg, Brazil
Baltimore, Maryland, United States
London, , United Kingdom
Foxboro, Massachusetts, United States
Stamford, Connecticut, United States
Tampa, Florida, United States
Cleveland, Ohio, United States
Münster, , Germany
Loures, , Portugal
Barcelona, , Spain
Overpelt, , Belgium
Besançon, , France
Tours, , France
Böblingen, , Germany
Dresden, , Germany
Erbach/Odenwald, , Germany
Hamburg, , Germany
Kassel, , Germany
Marburg, , Germany
Oldenburg In Holstein, , Germany
Napoli, Campania, Italy
Napoli, Campania, Italy
Roma, Lazio, Italy
Roma, Lazio, Italy
Genova, Liguria, Italy
Gallarate, Lombardia, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Pozzilli, Molise, Italy
Catania, Sicilia, Italy
Palermo, Sicilia, Italy
Firenze, Toscana, Italy
Stockholm, , Sweden
Warszawa, , Poland
Warszawa, , Poland
Sunnyvale, California, United States
Overland Park, Kansas, United States
Bedford, Texas, United States
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Camperdown, New South Wales, Australia
Box Hill, Victoria, Australia
Heidelberg, Victoria, Australia
Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Wien, , Austria
Curitiba, Pr, Brazil
Vancouver, British Columbia, Canada
London, Ontario, Canada
Aalborg, , Denmark
Glostrup, , Denmark
Bron, , France
Gonesse, , France
La Tronche, , France
Nancy, , France
Suresnes, , France
Toulon, , France
Barsinghausen, , Germany
Essen, , Germany
Kiel, , Germany
Neuburg, , Germany
Seesen, , Germany
Esztergom, , Hungary
Catanzaro, Calabria, Italy
Trieste, Friuli Venezia Giulia, Italy
Grosseto, Toscana, Italy
Siena, Toscana, Italy
Kuwait, , Kuwait
Ciudad De México, Mexico City (Federal District), Mexico
Culiacán, Sinaloa, Mexico
Ciudad De México, , Mexico
Amsterdam, , Netherlands
Lørenskog, , Norway
Bydgoszcz, , Poland
Katowice, , Poland
Krakow, , Poland
Lublin, , Poland
Bucharest, , Romania
Targu Mures, , Romania
Bratislava, , Slovakia
Bratislava, , Slovakia
Nitra, , Slovakia
Ljubljana, , Slovenia
Alicante, , Spain
Murcia, , Spain
Karlstad, , Sweden
Bern, , Switzerland
Luzern, , Switzerland
St. Gallen, , Switzerland
Ankara, , Turkey
Hatay, , Turkey
Istanbul, , Turkey
Konya, , Turkey
Lille, , France
Brest, , France
Le Mans, , France
Lille, , France
Poitiers, , France
Napoli, Campania, Italy
Cona, Emilia Romagna, Italy
Westmead, New South Wales, Australia
Unterhaching, , Germany
Helsinki, , Finland
Buenos Aires, , Argentina
Herlev, , Denmark
Turku, , Finland
Ars Laquenexy, , France
La Roche Sur Yon Cedex 9, , France
Köln, , Germany
Ludwigshafen, , Germany
Teupitz, , Germany
Roma, Lazio, Italy
Empoli, Toscana, Italy
Kosice, , Slovakia
Busa, , Turkey
Dudley, , United Kingdom
Plymouth, , United Kingdom
Sydney, New South Wales, Australia
Hickory, North Carolina, United States
Caen, , France
Mexico, Tlaxcala, Mexico
Esztergom, , Hungary
Istanbul, , Turkey
Gdansk, , Poland
Aarhus N, , Denmark
Ankara, , Turkey
Madrid, , Spain
Hatay, , Turkey
Trnava, , Slovakia
Budapest, , Hungary
Sao Paulo, Sp, Brazil
Lublin, , Poland
Bratislava, , Slovakia
Bratislava, , Slovakia
Böblingen, , Germany
London, , United Kingdom
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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