Multiple Sclerosis Clinical Trial
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Summary
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
Full Description
This was a randomized, double-blind, double-dummy, active comparatorcontrolled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study for an individual patient was 2.5 years. Eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at Week 4. In order to blind for the different formulations, double-dummy masking was used, i.e., all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 174 Locations for this study
Birmingham Alabama, 35233, United States
Cullman Alabama, 35058, United States
Tucson Arizona, 85704, United States
Aurora Colorado, 80045, United States
Basalt Colorado, 81621, United States
Boulder Colorado, 80301, United States
Centennial Colorado, 80112, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80210, United States
Fort Collins Colorado, 80528, United States
Fort Collins Colorado, 907-2, United States
Fairfield Connecticut, 06824, United States
Newark Delaware, 19713, United States
Bradenton Florida, 34205, United States
Gainesville Florida, 32611, United States
Maitland Florida, 32751, United States
Ocala Florida, 34471, United States
Oldsmar Florida, 34677, United States
Ormond Beach Florida, 32174, United States
Palm Coast Florida, 32164, United States
Saint Petersburg Florida, 33713, United States
Sarasota Florida, 34243, United States
Tallahassee Florida, 32312, United States
Tampa Florida, 33603, United States
Tampa Florida, 33609, United States
Tampa Florida, 33612, United States
Suwanee Georgia, 30024, United States
Anderson Indiana, 46011, United States
Indianapolis Indiana, 46256, United States
Wellesley Massachusetts, 02481, United States
Detroit Michigan, 48202, United States
Golden Valley Minnesota, 55422, United States
Billings Montana, 59101, United States
Great Falls Montana, 59405, United States
Albuquerque New Mexico, 87131, United States
Asheville North Carolina, 28806, United States
Charlotte North Carolina, 28202, United States
Greensboro North Carolina, 27405, United States
Akron Ohio, 44320, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43221, United States
Westerville Ohio, 43081, United States
Portland Oregon, 97225, United States
Pittsburgh Pennsylvania, 15212, United States
Willow Grove Pennsylvania, 19090, United States
Greer South Carolina, 29650, United States
Cordova Tennessee, 38018, United States
Knoxville Tennessee, 37922, United States
Nashville Tennessee, 37205, United States
Greenville Texas, 75401, United States
Lubbock Texas, 79410, United States
Sherman Texas, 75092, United States
Orem Utah, 84058, United States
Salt Lake City Utah, 84103, United States
Salt Lake City Utah, 84132, United States
Kirkland Washington, 98034, United States
Seattle Washington, 98122, United States
Tacoma Washington, 98405, United States
Waukesha Wisconsin, 53188, United States
Caba Buenos Aires, C1428, Argentina
Rosario Santa Fe, S2000, Argentina
Tucuman , 4000, Argentina
Liverpool New South Wales, 2170, Australia
Vienna , 1090, Austria
Wien , 1010, Austria
Edegem Antwerpen, 2650, Belgium
Aalst , 9300, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Sofia , 1113, Bulgaria
Sofia , 1413, Bulgaria
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Greenfield Park Quebec, J4V 2, Canada
Osijek , 31000, Croatia
Zagreb , 10000, Croatia
Brno Czech Republic, 656 9, Czechia
Havirov Czech Republic, 736 0, Czechia
Teplice Czech Republic, 415 0, Czechia
Ostrava-Poruba , 708 5, Czechia
Praha 10 , 100 3, Czechia
Tampere , 33100, Finland
Turku , 20520, Finland
Nice Cedex1, 06001, France
Bordeaux Cedex , 33076, France
Clermont-Ferrand , 63000, France
Montpellier , 34295, France
Paris Cedex 13 , 75651, France
Rennes Cedex , 35033, France
Strasbourg , 67098, France
Bochum , 44791, Germany
Dresden , 01307, Germany
Essen , 45147, Germany
Hamburg , 22179, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Homburg , 66421, Germany
Koln , 50935, Germany
Leipzig , 04103, Germany
Leipzig , 04107, Germany
Minden , 32429, Germany
Siegen , 57076, Germany
Ulm , 89081, Germany
Unterhaching , 82008, Germany
Budapest HUN, 1204, Hungary
Esztergom HUN, 2500, Hungary
Hyderabad Andhra Pradesh, 50001, India
New Delhi Delhi, 110 0, India
Mumbai Maharashtra, 40000, India
Mumbai Maharashtra, 40001, India
Pune Maharashtra, 41100, India
Ludhiana Punjab, 14100, India
Mumbai , 40001, India
Padova PD, 35128, Italy
Roma RM, 00133, Italy
Genova , 16132, Italy
Milano , 20133, Italy
Napoli , 80138, Italy
Rome , 00178, Italy
Riga LV, LV-10, Latvia
Riga , LV 10, Latvia
Riga , LV-10, Latvia
Kaunas LTU, LT 50, Lithuania
Vilnius , LT-08, Lithuania
Chihuahua , 31238, Mexico
Drammen , 1086, Norway
Cercado De Lima Lima, 01, Peru
San Isidro Lima, 27, Peru
Lima , LIMA , Peru
Glogow , 36-06, Poland
Rzeszow , 35 05, Poland
Warszawa , 02 95, Poland
Wroclaw , 51-68, Poland
Zabrze , 41-80, Poland
Matosinhos Porto, 44545, Portugal
Amadora , 2720-, Portugal
Braga , 47102, Portugal
Coimbra , 3000-, Portugal
Lisboa , 1169-, Portugal
Lisboa , 1500 , Portugal
Lisboa , 16001, Portugal
Loures , 26745, Portugal
Porto , 40000, Portugal
Santa Maria da Feira , 4520 , Portugal
Ekaterinburg , 62010, Russian Federation
Kazan , 42002, Russian Federation
Krasnoyarsk , 66004, Russian Federation
Moscow , 12701, Russian Federation
Nizhny Novgorod , 60313, Russian Federation
Novosibirsk , 63008, Russian Federation
Saint Petersburg , 19702, Russian Federation
St. Petersburg , 19711, Russian Federation
St. Petersburg , 19737, Russian Federation
Bratislava , 813 6, Slovakia
Martin , 036 5, Slovakia
Ruzomberok , 03426, Slovakia
Pretoria , 0041, South Africa
Rosebank , 2196, South Africa
Malaga Andalucia, 29010, Spain
Sevilla Andalucia, 41017, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Baracaldo Vizcaya, 48903, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28222, Spain
San Sebastian , 20014, Spain
Lugano , 6900, Switzerland
Tainan , 70403, Taiwan
Haseki / Istanbul , 34096, Turkey
Izmir , 35340, Turkey
Mersin , 33079, Turkey
Trabzon , 61080, Turkey
Luton Beds, LU4 0, United Kingdom
Sheffield South Yorkshire, S10 2, United Kingdom
London , SE5 9, United Kingdom
London , SW17 , United Kingdom
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