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

• Status: Completed
• Trial end date: 2020-10-22
• 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