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

Completed · Phase 3 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT02792218

Run by

Novartis Pharmaceuticals

People needed

930

Starts

2016-09-20

Expected to finish

2020-07-20

Last updated by the study team

2021-10-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Berkeley, California, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Atlantis, Florida, United States
• Novartis Investigative Site — Delray Beach, Florida, United States
• Novartis Investigative Site — Hollywood, Florida, United States
• Novartis Investigative Site — Loxahatchee Groves, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Naples, Florida, United States
• Novartis Investigative Site — North Palm Beach, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Port Charlotte, Florida, United States
• Novartis Investigative Site — Sunrise, Florida, United States
• Novartis Investigative Site — Vero Beach, Florida, United States
• Novartis Investigative Site — West Palm Beach, Florida, United States
• Novartis Investigative Site — Savannah, Georgia, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Northbrook, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Des Moines, Iowa, United States
• Novartis Investigative Site — Kansas City, Kansas, United States
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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