An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

F. Hoffmann-La Roche Ltd0 sites600 target enrollmentOctober 30, 2017

Overview

No summary available.

Registry

who.int

Start Date

October 30, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Able to comply with the study protocol, in the investigator’s judgment
•\- Age 18 \- 55 years, inclusive
•\- 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 multiple sclerosis (MS) disease of \<\= 3 years
•\- Within the last 12 months: one or more clinically reported relapse(s) or one or more signs of MRI activity
•\- Expanded Disability Status Scale (EDSS) of 0\.0 to 3\.5 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\- Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
•\- Inability to complete an Magnetic resonance imaging (MRI)
•\- Known presence of other neurological disorders, including but not limited to, the following:
•History of ischemic cerebrovascular disorders or ischemia of the spinal cord
•History or known presence of central nervous system (CNS) or spinal cord tumor
•History or known presence of potential metabolic causes of myelopathy
•History or known presence of infectious causes of myelopathy
•History of genetically inherited progressive CNS degenerative disorder
•Neuromyelitis optica
•History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease