A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
- Conditions
- Relapsing Multiple SclerosisMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-020337-99-CZ
- Lead Sponsor
- F.Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 821
Male and female participants between ages 18-55 with a diagnosis of relapsing multiple sclerosis
At least 2 documented clinical attacks within the last 2 years before screening or one clinical attack in the year before screening (but not within 30 days before screening)
Patients with EDSS score of 0-5.5, at Screening
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Patients with other chronic disease of the immune system, malignancies or other diseases or conditions that could preclude participant from participating in the study
Contraindications to or intolerance of oral or i.v. corticosteroids
Contraindication to or intolerance of interferon beta-1a (Rebif)
Pregnant or nursing women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method