None listed
Conditions
Interventions
Ocrelizumab 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle of the OLE Phase and as single infusions of 600 mg on Day 1 for each 24-week tre
Sponsors
F. Hoffmann- La Roche, Ltd /Genentech Inc,
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria are the following: 1.Ability to provide written, informed consent and be able to follow the schedule of protocol assessments *. 2.Ages 18-55 years at screening, inclusive. 3.Diagnosis of MS, in accordance with the revised McDonald criteria (2010). 4.At least 2 documented clinical attacks within the last 2 years prior to screening, or one clinical attack in the year prior to screening (but not within 30 days prior to screening). 5.Neurological stability for 30 days prior to both screening and baseline. 6.EDSS, at screening, from 0 to 5.5 inclusive. 7.Documented MRI of brain with abnormalities consistent with MS prior to screening. 8.Patients of reproductive potential must use reliable means of contraception as described below as a minimum (adherence to local requirements, if more stringent, is required**): •For female patients: Two methods of contraception throughout the trial, including the active treatment phase AND for 48 weeks after the last dose of ocrelizumab, or until their B-cells have repleted, whichever is longer. •For male patients: Two methods of contraception throughout the trial, including the active treatment phase AND for 24 weeks after the last dose of ocrelizumab.
Exclusion criteria
Exclusion criteria: •Primary progressive multiple sclerosis •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies •Chronic treatment with systemic corticosteroids or immunosuppressants, chronic immune system diseases or other conditions that may rule out the involvement of the patient in the study. •History of progressive multifocal leukoencephalopathy •Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis) •Known presence of other neurological disorders which may mimic multiple sclerosis •History of or currently active primary or secondary immunodeficiency •Pregnancy or lactation •Contraindications to or intolerance of oral or I.V. corticosteroids •Contraindication to or intolerance of interferon beta-1a (Rebif
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latovia, Lithuania, Mexico, Poland, Portugal, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed