An open-label extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS
Phase 3
Completed
- Conditions
- Relapsing Multiple Sclerosis
- Registration Number
- JPRN-jRCT2080224590
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 2010
Inclusion Criteria
Inclusion Criteria:
Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
Written informed consent
Exclusion Criteria
Exclusion Criteria:
- Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
- Subjects with neurological findings consistent with PML or confirmed PML
- Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
- Subjects taking medications prohibited by the protocol
- Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the long-term safety and tolerability of ofatumumab 20 mg subcutaneous(sc) once every 4 (q4) weeks in subjects with RMS from the first dose of ofatumumab
- Secondary Outcome Measures
Name Time Method