A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF OFATUMUMAB VERSUS TERIFLUNOMIDE IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS.

OVARTIS BIOSCIENSES PERU S.A.,0 sites8 target enrollmentMay 10, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 10, 2017

End Date

November 20, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

OVARTIS BIOSCIENSES PERU S.A.,

•1\. Written informed consent.
•2\. Male or female patients aged 18 to 55 years (inclusive) at Screening
•3\. Diagnosis of MS according to the 2010 Revised McDonald criteria
•4\. Relapsing MS: relapsing\-remitting course (RRMS), or secondary progressive (SPMS) course with disease activity
•5\. Disability status at Screening with an EDSS score of 0 to 5\.5 (inclusive)
•6\. Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd\-enhancing MRI scan during the year prior to randomization (Note: Screening MRI scan may be used if no positive Gd\-enhancing scan exist from prior year).
•7\. Neurologically stable within 1 month prior to randomization.

•1\. Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator.
•2\. Patients with primary progressive MS or SPMS without disease activity.
•3\. Patients meeting criteria for neuromyelitis optica.
•4\. Disease duration of more than 10 years in patients with EDSS score of 2 or less.
•5\. Pregnant or nursing (lactating) women.
•6\. Women of child\-bearing potential, unless they are using highly effective methods of contraception.
•7\. Sexually active males, unless they agree to use a condom during active treatment.
•8\. Patients with an active chronic disease of the immune system other than MS or with immunodeficiency syndrome.
•9\. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening.
•10\. Patients with neurological findings consistent with PML or confirmed PML.