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



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:1/11/2019
Start Date:August 26, 2016
End Date:May 15, 2019
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

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

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

This is a randomized, double-blind, double-dummy, active comparator-controlled,
parallel-group, multicenter study with variable treatment duration in approximately 900
patients with relapsing MS. The maximal treatment duration in the study for an individual
patient will be 2.5 years.

Eligible patients will be randomized to receive either experimental ofatumumab subcutaneous
(sc) injections every 4 weeks or active comparator teriflunomide orally once daily. In order
to blind for the different formulations, double-dummy masking will be used i.e. all patients
will take injections (containing either active ofatumumab or placebo) and oral capsules
(containing either active teriflunomide or placebo).

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

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
78
sites
Waukesha, Wisconsin 53188
?
mi
from
Waukesha, WI
Click here to add this to my saved trials
Akron, Ohio 44308
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Anderson, Indiana 46016
?
mi
from
Anderson, IN
Click here to add this to my saved trials
Asheville, North Carolina 28803
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Basalt, Colorado 81621
?
mi
from
Basalt, CO
Click here to add this to my saved trials
Billings Montana, Montana 59101
?
mi
from
Billings Montana, MT
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boulder, Colorado 80304
?
mi
from
Boulder, CO
Click here to add this to my saved trials
Bradenton, Florida 32405
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Caba, Buenos Aires
?
mi
from
Caba,
Click here to add this to my saved trials
Centennial, Colorado 80112
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43205
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Cordova, Tennessee 38018
?
mi
from
Cordova, TN
Click here to add this to my saved trials
Cullman, Alabama 35058
?
mi
from
Cullman, AL
Click here to add this to my saved trials
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Fairfield, Connecticut 06824
?
mi
from
Fairfield, CT
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Flossmoor, Illinois 60422
?
mi
from
Flossmoor, IL
Click here to add this to my saved trials
Fort Collins, Colorado 90728
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
250 Massachusetts Avenue
Foxboro, Massachusetts 02035
?
mi
from
Foxboro, MA
Click here to add this to my saved trials
Freehold, New Jersey 07728
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
Gainesville, Florida 32608
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Golden Valley, Minnesota 55422
?
mi
from
Golden Valley, MN
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Great Falls, Montana 59405
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, Texas 75401
?
mi
from
Greenville, TX
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Hendersonville, North Carolina 28792
?
mi
from
Hendersonville, NC
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kirkland, Washington 98034
?
mi
from
Kirkland, WA
Click here to add this to my saved trials
Knoxville, Tennessee 37934
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Lexington, Massachusetts 02421
?
mi
from
Lexington, MA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lubbock, Texas 79410
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Oldsmar, Florida 34677
?
mi
from
Oldsmar, FL
Click here to add this to my saved trials
Omaha, Nebraska 68144
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orem, Utah 84058
?
mi
from
Orem, UT
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Palm Coast, Florida 32164
?
mi
from
Palm Coast, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plainview, New York 11803
?
mi
from
Plainview, NY
Click here to add this to my saved trials
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84103
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Seattle, Washington 98103
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sherman, Texas 75092
?
mi
from
Sherman, TX
Click here to add this to my saved trials
Springfield, Oregon 97477
?
mi
from
Springfield, OR
Click here to add this to my saved trials
Suwanee, Georgia 30024
?
mi
from
Suwanee, GA
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Tucson, Arizona 85745
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Uniontown, Ohio 44685
?
mi
from
Uniontown, OH
Click here to add this to my saved trials
250 Massachusetts Avenue
Wellesley, Massachusetts 02481
?
mi
from
Wellesley, MA
Click here to add this to my saved trials
Westerville, Ohio 43081
?
mi
from
Westerville, OH
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials
Worcester, Massachusetts 01665
?
mi
from
Worcester, MA
Click here to add this to my saved trials