Overview

Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

Status:
Completed
Trial end date:
2020-07-20
Target enrollment:
0
Participant gender:
All
Summary
To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Antibodies, Monoclonal
Ofatumumab
Teriflunomide
Criteria
Inclusion Criteria:

- 18 to 55 years of age

- Diagnosis of multiple sclerosis (MS)

- Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)

- 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

- Expanded disability status scale (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