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

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

ClinicalTrials.gov Identifier: NCT02792231

Novartis Reference Number: COMB157G2302

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Relapsing Multiple Scelrosis
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
957 participants
Start date 
Aug 26, 2016
Completion date 
Dec 04, 2020
Gender 
All
Age(s)
18 Years - 55 Years (Adult)

Interventions

Drug
Ofatumumab subcutaneous injection
Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
Drug
Teriflunomide-matching placebo capsules
Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
Drug
Teriflunomide capsule
Teriflunomide 14 mg oral capsule taken once daily
Drug
Matching placebo of ofatumumab subcutaneous injections
Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter

Eligibility Criteria

Inclusion Criteria:

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

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

Study Locations

United States
Novartis Investigative Site
-
Birmingham, 35233-0271
Alabama
United States
Novartis Investigative Site
-
Cullman, 35058
Alabama
United States
Novartis Investigative Site
-
Tucson, 85704
Arizona
United States
Novartis Investigative Site
-
Aurora, 80045
Colorado
United States
Novartis Investigative Site
-
Basalt, 81621
Colorado
United States
Novartis Investigative Site
-
Boulder, 80301
Colorado
United States
Novartis Investigative Site
-
Centennial, 80112
Colorado
United States
Novartis Investigative Site
-
Colorado Springs, 80907
Colorado
United States
Novartis Investigative Site
-
Denver, 80210
Colorado
United States
Novartis Investigative Site
-
Fort Collins, 80528
Colorado
United States
Novartis Investigative Site
-
Fort Collins, 907-280528
Colorado
United States
Novartis Investigative Site
-
Fairfield, 06824
Connecticut
United States
Novartis Investigative Site
-
Newark, 19713
Delaware
United States
Novartis Investigative Site
-
Bradenton, 34205
Florida
United States
Novartis Investigative Site
-
Gainesville, 32611
Florida
United States
Novartis Investigative Site
-
Maitland, 32751
Florida
United States
Novartis Investigative Site
-
Ocala, 34471
Florida
United States
Novartis Investigative Site
-
Oldsmar, 34677
Florida
United States
Novartis Investigative Site
-
Ormond Beach, 32174
Florida
United States
Novartis Investigative Site
-
Palm Coast, 32164
Florida
United States
Novartis Investigative Site
-
Saint Petersburg, 33713
Florida
United States
Novartis Investigative Site
-
Sarasota, 34243
Florida
United States
Novartis Investigative Site
-
Tallahassee, 32312
Florida
United States
Novartis Investigative Site
-
Tampa, 33603
Florida
United States
Novartis Investigative Site
-
Tampa, 33609
Florida
United States
Novartis Investigative Site
-
Tampa, 33612
Florida
United States
Novartis Investigative Site
-
Suwanee, 30024
Georgia
United States
Novartis Investigative Site
-
Anderson, 46011
Indiana
United States
Novartis Investigative Site
-
Indianapolis, 46256
Indiana
United States
Novartis Investigative Site
-
Wellesley, 02481
Massachusetts
United States
Novartis Investigative Site
-
Detroit, 48202
Michigan
United States
Novartis Investigative Site
-
Golden Valley, 55422
Minnesota
United States
Novartis Investigative Site
-
Billings, 59101
Montana
United States
Novartis Investigative Site
-
Great Falls, 59405
Montana
United States
Novartis Investigative Site
-
Albuquerque, 87131-0001
New Mexico
United States
Novartis Investigative Site
-
Asheville, 28806
North Carolina
United States
Novartis Investigative Site
-
Charlotte, 28202
North Carolina
United States
Novartis Investigative Site
-
Greensboro, 27405
North Carolina
United States
Novartis Investigative Site
-
Akron, 44320
Ohio
United States
Novartis Investigative Site
-
Columbus, 43214
Ohio
United States
Novartis Investigative Site
-
Columbus, 43221
Ohio
United States
Novartis Investigative Site
-
Westerville, 43081
Ohio
United States
Novartis Investigative Site
-
Portland, 97225
Oregon
United States
Novartis Investigative Site
-
Pittsburgh, 15212
Pennsylvania
United States
Novartis Investigative Site
-
Willow Grove, 19090
Pennsylvania
United States
Novartis Investigative Site
-
Greer, 29650
South Carolina
United States
Novartis Investigative Site
-
Cordova, 38018
Tennessee
United States
Novartis Investigative Site
-
Knoxville, 37922
Tennessee
United States
Novartis Investigative Site
-
Nashville, 37205
Tennessee
United States
Novartis Investigative Site
-
Greenville, 75401
Texas
United States
Novartis Investigative Site
-
Lubbock, 79410
Texas
United States
Novartis Investigative Site
-
Sherman, 75092
Texas
United States
Novartis Investigative Site
-
Orem, 84058
Utah
United States
Novartis Investigative Site
-
Salt Lake City, 84103
Utah
United States
Novartis Investigative Site
-
Salt Lake City, 84132
Utah
United States
Novartis Investigative Site
-
Kirkland, 98034
Washington
United States
Novartis Investigative Site
-
Seattle, 98122
Washington
United States
Novartis Investigative Site
-
Tacoma, 98405
Washington
United States
Novartis Investigative Site
-
Waukesha, 53188
Wisconsin
United States
Argentina
Novartis Investigative Site
-
Caba, C1428AQK
Buenos Aires
Argentina
Novartis Investigative Site
-
Rosario, S2000DSW
Santa Fe
Argentina
Novartis Investigative Site
-
Tucuman, 4000
-
Argentina
Australia
Novartis Investigative Site
-
Liverpool, 2170
New South Wales
Australia
Austria
Novartis Investigative Site
-
Vienna, 1010
-
Austria
Novartis Investigative Site
-
Vienna, 1090
-
Austria
Belgium
Novartis Investigative Site
-
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
-
Aalst, 9300
-
Belgium
Novartis Investigative Site
-
Bruxelles, 1200
-
Belgium
Novartis Investigative Site
-
Gent, 9000
-
Belgium
Bulgaria
Novartis Investigative Site
-
Sofia, 1113
-
Bulgaria
Novartis Investigative Site
-
Sofia, 1413
-
Bulgaria
Canada
Novartis Investigative Site
-
London, N6A 5A5
Ontario
Canada
Novartis Investigative Site
-
Ottawa, K1H 8L6
Ontario
Canada
Novartis Investigative Site
-
Toronto, M4N 3M5
Ontario
Canada
Novartis Investigative Site
-
Greenfield Park, J4V 2J2
Quebec
Canada
Croatia
Novartis Investigative Site
-
Osijek, 31000
-
Croatia
Novartis Investigative Site
-
Zagreb, 10000
-
Croatia
Czechia
Novartis Investigative Site
-
Brno, 656 91
Czech Republic
Czechia
Novartis Investigative Site
-
Havirov, 736 01
Czech Republic
Czechia
Novartis Investigative Site
-
Teplice, 415 01
Czech Republic
Czechia
Novartis Investigative Site
-
Ostrava-Poruba, 708 52
-
Czechia
Novartis Investigative Site
-
Praha 10, 100 34
-
Czechia
Finland
Novartis Investigative Site
-
Tampere, 33100
-
Finland
Novartis Investigative Site
-
Turku, 20520
-
Finland
France
Novartis Investigative Site
-
Nice, 06001
Cedex1
France
Novartis Investigative Site
-
Bordeaux Cedex, 33076
-
France
Novartis Investigative Site
-
Clermont-Ferrand, 63000
-
France
Novartis Investigative Site
-
Montpellier, 34295
-
France
Novartis Investigative Site
-
Paris Cedex 13, 75651
-
France
Novartis Investigative Site
-
Rennes Cedex, 35033
-
France
Novartis Investigative Site
-
Strasbourg, 67098
-
France
Germany
Novartis Investigative Site
-
Bochum, 44791
-
Germany
Novartis Investigative Site
-
Dresden, 01307
-
Germany
Novartis Investigative Site
-
Essen, 45147
-
Germany
Novartis Investigative Site
-
Hamburg, 22179
-
Germany
Novartis Investigative Site
-
Hannover, 30625
-
Germany
Novartis Investigative Site
-
Heidelberg, 69120
-
Germany
Novartis Investigative Site
-
Homburg, 66421
-
Germany
Novartis Investigative Site
-
Koln, 50935
-
Germany
Novartis Investigative Site
-
Leipzig, 04103
-
Germany
Novartis Investigative Site
-
Leipzig, 04107
-
Germany
Novartis Investigative Site
-
Minden, 32429
-
Germany
Novartis Investigative Site
-
Siegen, 57076
-
Germany
Novartis Investigative Site
-
Ulm, 89081
-
Germany
Novartis Investigative Site
-
Unterhaching, 82008
-
Germany
Hungary
Novartis Investigative Site
-
Budapest, 1204
HUN
Hungary
Novartis Investigative Site
-
Esztergom, 2500
HUN
Hungary
India
Novartis Investigative Site
-
Hyderabad, 500018
Andhra Pradesh
India
Novartis Investigative Site
-
New Delhi, 110 060
Delhi
India
Novartis Investigative Site
-
Mumbai, 400008
Maharashtra
India
Novartis Investigative Site
-
Mumbai, 400012
Maharashtra
India
Novartis Investigative Site
-
Pune, 411004
Maharashtra
India
Novartis Investigative Site
-
Ludhiana, 141008
Punjab
India
Novartis Investigative Site
-
Mumbai, 400016
-
India
Italy
Novartis Investigative Site
-
Padova, 35128
PD
Italy
Novartis Investigative Site
-
Roma, 00133
RM
Italy
Novartis Investigative Site
-
Genova, 16132
-
Italy
Novartis Investigative Site
-
Milano, 20133
-
Italy
Novartis Investigative Site
-
Napoli, 80138
-
Italy
Novartis Investigative Site
-
Rome, 00178
-
Italy
Latvia
Novartis Investigative Site
-
Riga, LV-1005
LV
Latvia
Novartis Investigative Site
-
Riga, LV 1002
-
Latvia
Novartis Investigative Site
-
Riga, LV-1038
-
Latvia
Lithuania
Novartis Investigative Site
-
Kaunas, LT 50161
LTU
Lithuania
Novartis Investigative Site
-
Vilnius, LT-08661
-
Lithuania
Mexico
Novartis Investigative Site
-
Chihuahua, 31238
-
Mexico
Norway
Novartis Investigative Site
-
Drammen, 1086
-
Norway
Peru
Novartis Investigative Site
-
Cercado De Lima, 01
Lima
Peru
Novartis Investigative Site
-
San Isidro, 27
Lima
Peru
Novartis Investigative Site
-
Lima, LIMA 13
-
Peru
Poland
Novartis Investigative Site
-
Glogow, 36-060
-
Poland
Novartis Investigative Site
-
Rzeszow, 35 055
-
Poland
Novartis Investigative Site
-
Warszawa, 02 957
-
Poland
Novartis Investigative Site
-
Wroclaw, 51-685
-
Poland
Novartis Investigative Site
-
Zabrze, 41-800
-
Poland
Portugal
Novartis Investigative Site
-
Matosinhos, 4454509
Porto
Portugal
Novartis Investigative Site
-
Amadora, 2720-276
-
Portugal
Novartis Investigative Site
-
Braga, 4710243
-
Portugal
Novartis Investigative Site
-
Coimbra, 3000-075
-
Portugal
Novartis Investigative Site
-
Lisboa, 1169-050
-
Portugal
Novartis Investigative Site
-
Lisboa, 1500 650
-
Portugal
Novartis Investigative Site
-
Lisboa, 1600190
-
Portugal
Novartis Investigative Site
-
Loures, 2674514
-
Portugal
Novartis Investigative Site
-
Porto, 4000001
-
Portugal
Novartis Investigative Site
-
Santa Maria da Feira, 4520 211
-
Portugal
Russian Federation
Novartis Investigative Site
-
Ekaterinburg, 620109
-
Russian Federation
Novartis Investigative Site
-
Kazan, 420021
-
Russian Federation
Novartis Investigative Site
-
Krasnoyarsk, 660049
-
Russian Federation
Novartis Investigative Site
-
Moscow, 127015
-
Russian Federation
Novartis Investigative Site
-
Nizhny Novgorod, 603137
-
Russian Federation
Novartis Investigative Site
-
Novosibirsk, 630087
-
Russian Federation
Novartis Investigative Site
-
Saint Petersburg, 197022
-
Russian Federation
Novartis Investigative Site
-
St. Petersburg, 197110
-
Russian Federation
Novartis Investigative Site
-
St. Petersburg, 197376
-
Russian Federation
Slovakia
Novartis Investigative Site
-
Bratislava, 813 69
-
Slovakia
Novartis Investigative Site
-
Martin, 036 59
-
Slovakia
Novartis Investigative Site
-
Ruzomberok, 03426
-
Slovakia
South Africa
Novartis Investigative Site
-
Pretoria, 0041
-
South Africa
Novartis Investigative Site
-
Rosebank, 2196
-
South Africa
Spain
Novartis Investigative Site
-
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
-
Sevilla, 41017
Andalucia
Spain
Novartis Investigative Site
-
Pozuelo de Alarcon, 28223
Madrid
Spain
Novartis Investigative Site
-
Baracaldo, 48903
Vizcaya
Spain
Novartis Investigative Site
-
Madrid, 28006
-
Spain
Novartis Investigative Site
-
Madrid, 28034
-
Spain
Novartis Investigative Site
-
Madrid, 28040
-
Spain
Novartis Investigative Site
-
Madrid, 28222
-
Spain
Novartis Investigative Site
-
San Sebastian, 20014
-
Spain
Switzerland
Novartis Investigative Site
-
Lugano, 6900
-
Switzerland
Taiwan
Novartis Investigative Site
-
Tainan, 70403
-
Taiwan
Turkey
Novartis Investigative Site
-
Haseki / Istanbul, 34096
-
Turkey
Novartis Investigative Site
-
Izmir, 35340
-
Turkey
Novartis Investigative Site
-
Mersin, 33079
-
Turkey
Novartis Investigative Site
-
Trabzon, 61080
-
Turkey
United Kingdom
Novartis Investigative Site
-
Luton, LU4 0DZ
Beds
United Kingdom
Novartis Investigative Site
-
Sheffield, S10 2JF
South Yorkshire
United Kingdom
Novartis Investigative Site
-
London, SE5 9RS
-
United Kingdom
Novartis Investigative Site
-
London, SW17 0QT
-
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]