Last Verified: | June/30/2020 |
First Submitted: | June/1/2016 |
Estimated Enrollment Submitted: | June/1/2016 |
First Posted: | June/6/2016 |
Last Update Submitted: | July/19/2020 |
Last Update Posted: | July/21/2020 |
: | September/23/2019 |
: | September/23/2019 |
: | October/7/2019 |
Actual Study Start Date: | August/25/2016 |
Estimated Primary Completion Date: | July/9/2019 |
Estimated Study Completion Date: | August/20/2020 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Arm | Intervention/treatment |
---|---|
Experimental: Ofatumumab Syringes for subcutaneous injection Patients will also take a placebo capsule (matching in appearance to teriflunomide) | Drug: Ofatumumab Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab every 4 weeks |
Active Comparator: Teriflunomide Oral capsule Patients will also take subcutaneous injections of placebo (syringes matching in appearance to ofatumumab) | Drug: Teriflunomide Patients randomized to the teriflunomide arm will take teriflunomide orally once daily |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - Diagnosis of multiple sclerosis (MS) - Relapsing MS (RRMS or SPMS) course - 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 - 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 Other protocol-defined inclusion/exclusion criteria may apply |