CompletedPhase 3DMT
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)
Sponsored by Hoffmann-La Roche
NCT ID
NCT02861014
Target Enrollment
681 participants
Start Date
2016-09-09
Est. Completion
2020-12-15
About This Study
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.
Conditions Studied
Interventions
- •Ocrelizumab
Eligibility
Age:18 Years - 55 Years
Healthy Volunteers:No
View full 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
Study Locations (163)
St George Hospital
Kogarah, New South Wales, New South Wales, Australia
Hospital Erasme
Brussels, Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Gent
Ghent, Belgium
CHU Tivoli
La Louvière, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Nationaal MS Centrum
Melsbroek, Belgium
Revalidatie en MS Centrum
Overpelt, Belgium
Fakultni nemocnice u sv. Anny; Neurologicka klinika
Brno, Czechia
+153 more locations