Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsingmultiple sclerosis
Phase 3
- Conditions
- Health Condition 1: null- Relapsing Multiple Scelrosis
- Registration Number
- CTRI/2017/03/008166
- 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
•Disease duration of more than 10 years in patients with an EDSS score of 2 or less
•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
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 umber of gadolinium (Gd)-enhancing lesions per MRI scanTimepoint: Time Frame: Baseline, yearly up to 2.5 years;Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate)Timepoint: Time Frame: Baseline, yearly up to 2.5 years;Rate of brain volume loss based on assessments of percentage brain volume change from baselineTimepoint: Time Frame: Baseline, yearly up to 2.5 years;Time to 3-month confirmed disability worsening on EDSSTimepoint: Time Frame: Baseline, every 3 months up to 2.5 years;Time to 6-month confirmed disability improvement on EDSSTimepoint: Time Frame: Baseline, every 3 months up to 2.5 years;Time to 6-month confirmed disability worsening on EDSSTimepoint: Time Frame: Baseline, every 3 months up to 2.5 years