A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Launched by HOFFMANN-LA ROCHE · Aug 5, 2016
Trial Information
Current as of May 13, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
- • Have a length of disease duration, from first symptom, of less than (\<) 10 years
- • Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
- • Suboptimal disease control while on a DMT
- • Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
- • For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
- Exclusion Criteria:
- • Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
- • Inability to complete an Magnetic Resonance Imaging (MRI) procedure
- • Known presence of other neurological disorders
- • 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
- • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- • History of opportunistic infections
- • History or known presence of recurrent or chronic infection
- • History of malignancy
- • Congestive heart failure
- • Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
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
Dublin, , Ireland
Newcastle Upon Tyne, , United Kingdom
Gent, , Belgium
Bruxelles, , Belgium
Leuven, , Belgium
London, , United Kingdom
Breda, , Netherlands
Edinburgh, , United Kingdom
Bergen, , Norway
Tallinn, , Estonia
Tartu, , Estonia
La Louvière, , Belgium
Edegem, , Belgium
Swansea, , United Kingdom
Praha, , Czechia
Aarhus N, , Denmark
Clermont Ferrand, , France
Berlin, , Germany
Sevilla, , Spain
Izmir, , Turkey
Truro, , United Kingdom
Salford, , United Kingdom
London, , United Kingdom
Nieuwegein, , Netherlands
Melsbroek, , Belgium
Bordeaux, , France
Bron, , France
Lille, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Reims, , France
Berg, , Germany
Berlin, , Germany
Tübingen, , Germany
Cagliari, Sardegna, Italy
Sittard Geleen, , Netherlands
Salt, Girona, Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Leipzig, , Germany
Madrid, , Spain
Madrid, , Spain
Brno, , Czechia
Jihlava, , Czechia
Prague, , Czechia
Mainz, , Germany
Westerstede, , Germany
Padova, Veneto, Italy
Basel, , Switzerland
Toulouse, , France
Frankfurt, , Germany
München, , Germany
Dublin 4, , Ireland
Montichiari, Lombardia, Italy
L'hospitalet De Llobregat, Barcelona, Spain
Valencia, , Spain
Göteborg, , Sweden
Ankara, , Turkey
Istanbul, , Turkey
Samsun, , Turkey
Trabzon, , Turkey
Exeter, , United Kingdom
Bruxelles, , Belgium
Rotterdam, , Netherlands
Inverness, , United Kingdom
Glasgow, , United Kingdom
Kogarah, New South Wales, New South Wales, Australia
Bochum, , Germany
Sheffield, , United Kingdom
Leeds, , United Kingdom
Istanbul, , Turkey
Castelló De La Plana, Castellon, Spain
Lleida, Lerida, Spain
Pozuelo De Alarcon, Madrid, Spain
Vigo, Pontevedra, Spain
Tampere, , Finland
Münster, , Germany
Barcelona, , Spain
Murcia, , Spain
Valencia, , Spain
Overpelt, , Belgium
Glostrup, , Denmark
Odense C, , Denmark
Sønderborg, , Denmark
Tallinn, , Estonia
Turku, , Finland
Besançon, , France
Strasbourg, , France
Tours, , France
Augsburg, , Germany
Berlin, , Germany
Berlin, , Germany
Bonn, , Germany
Buchholz, , Germany
Böblingen, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Erbach/Odenwald, , Germany
Freiburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hannover, , Germany
Heidelberg, , Germany
Hennigsdorf, , Germany
Itzehoe, , Germany
Kassel, , Germany
Magdeburg, , Germany
Marburg, , Germany
München, , Germany
München, , Germany
Neuruppin, , Germany
Oldenburg In Holstein, , Germany
Potsdam, , Germany
Stuttgart, , Germany
Ulm, , Germany
Cork, , Ireland
Chieti, Abruzzo, Italy
L'aquila, Abruzzo, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Bologna, Emilia Romagna, Italy
Roma, Lazio, Italy
Roma, Lazio, Italy
Roma, Lazio, Italy
Roma, Lazio, Italy
Genova, Liguria, Italy
Bergamo, Lombardia, Italy
Gallarate, Lombardia, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Pavia, Lombardia, Italy
Ancona, Marche, Italy
Pozzilli, Molise, Italy
Barletta, Puglia, Italy
San Giovanni Rotondo, Puglia, Italy
Catania, Sicilia, Italy
Cefalù, Sicilia, Italy
Palermo, Sicilia, Italy
Palermo, Sicilia, Italy
Firenze, Toscana, Italy
Firenze, Toscana, Italy
Siena, Toscana, Italy
Perugia, Umbria, Italy
Verona, Veneto, Italy
Tilburg, , Netherlands
Drammen, , Norway
Oviedo, Asturias, Spain
Coruña, La Coruña, Spain
Cadiz, , Spain
Jönköping, , Sweden
Stockholm, , Sweden
Lausanne, , Switzerland
Kocaeli, , Turkey
Mersin, , Turkey
Birmingham, , United Kingdom
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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