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Sponsor: Hoffmann-La Roche
Conditions: Multiple Sclerosis, Relapsing-Remitting
Interventions: Ocrelizumab
Countries: Australia, Belgium, Czechia, Denmark, Estonia, Finland, France, Germany
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.
Sex: ALL
Age: 18 Years to 55 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Kogarah, New South Wales, New South Wales, Australia
- Brussels, Belgium
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
- La Louvière, Belgium
- Leuven, Belgium
- Melsbroek, Belgium
- Overpelt, Belgium
- Brno, Czechia
- Jihlava, Czechia
- Prague, Czechia
- Prague, Czechia
- Aarhus N, Denmark
- Glostrup Municipality, Denmark
- Odense C, Denmark
- Sønderborg, Denmark
- Tallinn, Estonia
- Tallinn, Estonia
- Tartu, Estonia
- Tampere, Finland
- Turku, Finland
- Besançon, France
- Bordeaux, France
- Bron, France
- Clermont-Ferrand, France
- Lille, France
- Marseille, France
- Montpellier, France
- Nantes, France
- + 133 more on CT.gov