Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
- Conditions
- Relapsing Multiple Sclerosis
- Registration Number
- JPRN-jRCT2080223655
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
* Diagnosis of multiple sclerosis (MS)
* Relapsing MS
* At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhanced T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization
* EDSS score of 0 to 5.5
* Primary progressive MS or SPMS without disease activity
*Patients with an active chronic disease of the immune system other than MS
* Patients at risk of developing or having reactivation of hepatitis
* Patients with active systemic infections or with neurological findings consistent with PML
Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (ofatumumab vs placebo) [ Time Frame: Week 12, 16, 20 and 24 ]<br>The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center.
- Secondary Outcome Measures
Name Time Method