Study of efficacy and safety of ofatumumab compared to teriflunomide inpatients with relapsing multiple sclerosis
Phase 3
- Conditions
- Health Condition 1: null- Relapsing Multiple Sclerosis
- Registration Number
- CTRI/2017/03/008181
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Diagnosis of multiple sclerosis (MS)
1.Relapsing MS (RRMS or SPMS) course
2.At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year
3.EDSS score of 0 to 5.5
Exclusion Criteria
Primary progressive MS
1.Disease duration of more than 10 years in patients with an EDSS score of 2 or less
2.Patients with an active chronic disease of the immune system other than MS
3.Patients at risk of developing or having reactivation of hepatitis
4.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 Annualized relapse rate (ARR)Timepoint: Time Frame: up to 2.5 years
- Secondary Outcome Measures
Name Time Method