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 Scelrosis

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

NCT02792231

Run by

Novartis Pharmaceuticals

People needed

955

Starts

2016-08-26

Expected to finish

2020-10-22

Last updated by the study team

2021-11-22

Who can join

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

You may qualify if…

• Male or female patients aged 18 to 55 years at Screening
• Diagnosis of multiple sclerosis (MS)
• Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity
• Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization
• Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5
• Neurologically stable within 1 month prior to randomization

You may not qualify if…

• Patients with primary progressive MS or SPMS without disease activity
• 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 — Cullman, Alabama, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Basalt, Colorado, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Centennial, Colorado, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Fort Collins, Colorado, United States
• Novartis Investigative Site — Fort Collins, Colorado, United States
• Novartis Investigative Site — Fairfield, Connecticut, United States
• Novartis Investigative Site — Newark, Delaware, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Maitland, Florida, United States
• Novartis Investigative Site — Ocala, Florida, United States
• Novartis Investigative Site — Oldsmar, Florida, United States
• Novartis Investigative Site — Ormond Beach, Florida, United States
• Novartis Investigative Site — Palm Coast, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Tallahassee, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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