EUCTR2016-002937-31-SE
Active, not recruiting
Phase 1
An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis
ConditionsRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsOcrevus
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsing remitting multiple sclerosis (RRMS)
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 1225
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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 or longer after the last dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •\- Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
- •\- Inability to complete a 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
Outcomes
Primary Outcomes
Not specified
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