Clinical Trial Details

Overview

Research Study Summary

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.

Purpose
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
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CW ID: 222919
Date Last Changed: February 3, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 to 55 Years
Overall Status
Recruiting
Lead Sponsor
Novartis
Facility Type
N/A

Eligibility

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
  • Contact

    Angela Aungst
    University of South Florida - Morsani Center for Advanced Healthcare
    13330 USF Laurel Dr
    Tampa, FL 33612
    Phone: (813) 974-6378

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