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

View Full Description

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).

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

955

Study ID:

NCT02792231

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 174 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35233, United States
Novartis Investigative Site
Cullman Alabama, 35058, United States
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Tucson Arizona, 85704, United States
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Aurora Colorado, 80045, United States
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Basalt Colorado, 81621, United States
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Boulder Colorado, 80301, United States
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Centennial Colorado, 80112, United States
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Colorado Springs Colorado, 80907, United States
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Denver Colorado, 80210, United States
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Fort Collins Colorado, 80528, United States
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Fort Collins Colorado, 907-2, United States
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Fairfield Connecticut, 06824, United States
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Newark Delaware, 19713, United States
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Bradenton Florida, 34205, United States
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Gainesville Florida, 32611, United States
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Maitland Florida, 32751, United States
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Ocala Florida, 34471, United States
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Oldsmar Florida, 34677, United States
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Ormond Beach Florida, 32174, United States
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Palm Coast Florida, 32164, United States
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Saint Petersburg Florida, 33713, United States
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Sarasota Florida, 34243, United States
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Tallahassee Florida, 32312, United States
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Tampa Florida, 33603, United States
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Tampa Florida, 33609, United States
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Tampa Florida, 33612, United States
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Suwanee Georgia, 30024, United States
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Anderson Indiana, 46011, United States
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Indianapolis Indiana, 46256, United States
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Wellesley Massachusetts, 02481, United States
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Detroit Michigan, 48202, United States
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Golden Valley Minnesota, 55422, United States
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Billings Montana, 59101, United States
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Great Falls Montana, 59405, United States
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Albuquerque New Mexico, 87131, United States
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Asheville North Carolina, 28806, United States
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Charlotte North Carolina, 28202, United States
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Greensboro North Carolina, 27405, United States
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Akron Ohio, 44320, United States
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Columbus Ohio, 43214, United States
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Columbus Ohio, 43221, United States
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Westerville Ohio, 43081, United States
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Portland Oregon, 97225, United States
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Pittsburgh Pennsylvania, 15212, United States
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Willow Grove Pennsylvania, 19090, United States
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Greer South Carolina, 29650, United States
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Cordova Tennessee, 38018, United States
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Knoxville Tennessee, 37922, United States
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Nashville Tennessee, 37205, United States
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Greenville Texas, 75401, United States
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Lubbock Texas, 79410, United States
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Sherman Texas, 75092, United States
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Orem Utah, 84058, United States
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Salt Lake City Utah, 84103, United States
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Salt Lake City Utah, 84132, United States
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Kirkland Washington, 98034, United States
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Seattle Washington, 98122, United States
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Tacoma Washington, 98405, United States
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Waukesha Wisconsin, 53188, United States
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Caba Buenos Aires, C1428, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
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Tucuman , 4000, Argentina
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Liverpool New South Wales, 2170, Australia
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Vienna , 1090, Austria
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Wien , 1010, Austria
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Edegem Antwerpen, 2650, Belgium
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Aalst , 9300, Belgium
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Bruxelles , 1200, Belgium
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Gent , 9000, Belgium
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Sofia , 1113, Bulgaria
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Sofia , 1413, Bulgaria
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London Ontario, N6A 5, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Osijek , 31000, Croatia
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Zagreb , 10000, Croatia
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Brno Czech Republic, 656 9, Czechia
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Havirov Czech Republic, 736 0, Czechia
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Teplice Czech Republic, 415 0, Czechia
Novartis Investigative Site
Ostrava-Poruba , 708 5, Czechia
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Praha 10 , 100 3, Czechia
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Tampere , 33100, Finland
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Turku , 20520, Finland
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Nice Cedex1, 06001, France
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Bordeaux Cedex , 33076, France
Novartis Investigative Site
Clermont-Ferrand , 63000, France
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Montpellier , 34295, France
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Paris Cedex 13 , 75651, France
Novartis Investigative Site
Rennes Cedex , 35033, France
Novartis Investigative Site
Strasbourg , 67098, France
Novartis Investigative Site
Bochum , 44791, Germany
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Dresden , 01307, Germany
Novartis Investigative Site
Essen , 45147, Germany
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Hamburg , 22179, Germany
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Hannover , 30625, Germany
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Heidelberg , 69120, Germany
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Homburg , 66421, Germany
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Koln , 50935, Germany
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Leipzig , 04103, Germany
Novartis Investigative Site
Leipzig , 04107, Germany
Novartis Investigative Site
Minden , 32429, Germany
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Siegen , 57076, Germany
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Ulm , 89081, Germany
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Unterhaching , 82008, Germany
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Budapest HUN, 1204, Hungary
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Esztergom HUN, 2500, Hungary
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Hyderabad Andhra Pradesh, 50001, India
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New Delhi Delhi, 110 0, India
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Mumbai Maharashtra, 40000, India
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Mumbai Maharashtra, 40001, India
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Pune Maharashtra, 41100, India
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Ludhiana Punjab, 14100, India
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Mumbai , 40001, India
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Padova PD, 35128, Italy
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Roma RM, 00133, Italy
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Genova , 16132, Italy
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Milano , 20133, Italy
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Napoli , 80138, Italy
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Rome , 00178, Italy
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Riga LV, LV-10, Latvia
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Riga , LV 10, Latvia
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Riga , LV-10, Latvia
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Kaunas LTU, LT 50, Lithuania
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Vilnius , LT-08, Lithuania
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Chihuahua , 31238, Mexico
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Drammen , 1086, Norway
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Cercado De Lima Lima, 01, Peru
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San Isidro Lima, 27, Peru
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Lima , LIMA , Peru
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Glogow , 36-06, Poland
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Rzeszow , 35 05, Poland
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Warszawa , 02 95, Poland
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Wroclaw , 51-68, Poland
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Zabrze , 41-80, Poland
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Matosinhos Porto, 44545, Portugal
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Amadora , 2720-, Portugal
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Braga , 47102, Portugal
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Coimbra , 3000-, Portugal
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Lisboa , 1169-, Portugal
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Lisboa , 1500 , Portugal
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Lisboa , 16001, Portugal
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Loures , 26745, Portugal
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Porto , 40000, Portugal
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Santa Maria da Feira , 4520 , Portugal
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Ekaterinburg , 62010, Russian Federation
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Kazan , 42002, Russian Federation
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Krasnoyarsk , 66004, Russian Federation
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Moscow , 12701, Russian Federation
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Nizhny Novgorod , 60313, Russian Federation
Novartis Investigative Site
Novosibirsk , 63008, Russian Federation
Novartis Investigative Site
Saint Petersburg , 19702, Russian Federation
Novartis Investigative Site
St. Petersburg , 19711, Russian Federation
Novartis Investigative Site
St. Petersburg , 19737, Russian Federation
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Bratislava , 813 6, Slovakia
Novartis Investigative Site
Martin , 036 5, Slovakia
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Ruzomberok , 03426, Slovakia
Novartis Investigative Site
Pretoria , 0041, South Africa
Novartis Investigative Site
Rosebank , 2196, South Africa
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Sevilla Andalucia, 41017, Spain
Novartis Investigative Site
Pozuelo de Alarcon Madrid, 28223, Spain
Novartis Investigative Site
Baracaldo Vizcaya, 48903, Spain
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Madrid , 28006, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28040, Spain
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Madrid , 28222, Spain
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San Sebastian , 20014, Spain
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Lugano , 6900, Switzerland
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Tainan , 70403, Taiwan
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Haseki / Istanbul , 34096, Turkey
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Izmir , 35340, Turkey
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Mersin , 33079, Turkey
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Trabzon , 61080, Turkey
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Luton Beds, LU4 0, United Kingdom
Novartis Investigative Site
Sheffield South Yorkshire, S10 2, United Kingdom
Novartis Investigative Site
London , SE5 9, United Kingdom
Novartis Investigative Site
London , SW17 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

955

Study ID:

NCT02792231

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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