Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis
NCT ID: NCT02792218
Last Updated: 2021-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
930 participants
INTERVENTIONAL
2016-09-20
2020-07-20
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OMB 20 mg
Ofatumumab 20 mg pre-filled syringes for subcutaneous injectionon on days 1 ,7 ,14, week 4 and every 4 weeks thereafter and a teriflunomide- matching placebo, taken orally once daily
Ofatumumab subcutaneous injection
Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
Teriflunomide-matching placebo capsules
Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
TER 14 mg
Teriflunomide 14 mg oral capsule taken once daily and matching placebo for subcutaneous injections to ofatumumab on days 1, 7, 14, week 4 and every 4 weeks thereafter
Teriflunomide capsule
Teriflunomide 14 mg oral capsule taken once daily
Matching placebo of ofatumumab subcutaneous injections
Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Interventions
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Ofatumumab subcutaneous injection
Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
Teriflunomide-matching placebo capsules
Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
Teriflunomide capsule
Teriflunomide 14 mg oral capsule taken once daily
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
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Phoenix, Arizona, United States
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Berkeley, California, United States
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Fullerton, California, United States
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Sacramento, California, United States
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Washington D.C., District of Columbia, United States
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Atlantis, Florida, United States
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Delray Beach, Florida, United States
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Hollywood, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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North Palm Beach, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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Sunrise, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Savannah, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Northbrook, Illinois, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Alexandria, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Clinton Township, Michigan, United States
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Detroit, Michigan, United States
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Golden Valley, Minnesota, United States
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Chesterfield, Missouri, United States
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Ozark, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Latham, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Spartanburg, South Carolina, United States
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Johnson City, Tennessee, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Virginia Beach, Virginia, United States
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Green Bay, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Neenah, Wisconsin, United States
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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New Lambton Heights, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Brasschaat, , Belgium
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Bruges, , Belgium
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Liège, , Belgium
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Overpelt, , Belgium
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Vancouver, British Columbia, Canada
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Gatineau, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Rijeka, HRV, Croatia
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Zagreb, , Croatia
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Praha 4 Krc, Czech Republic, Czechia
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Hradec Králové, CZE, Czechia
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Olomouc, CZE, Czechia
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Jihlava, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Odense C, , Denmark
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Tallinn, , Estonia
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Tartu, , Estonia
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Nancy, Cedex, France
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Lille, , France
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Nantes, , France
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Nîmes, , France
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Barsinghausen, , Germany
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Bayreuth, , Germany
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Bielefeld, , Germany
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Hamburg, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Neuburg an der Donau, , Germany
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Potsdam, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Athens, GR, Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Budapest, HUN, Hungary
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Budapest, , Hungary
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Kistarcsa, , Hungary
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Szeged, , Hungary
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Bangalore, Karnataka, India
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Kochi, Kerala, India
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New Delhi, National Capital Territory of Delhi, India
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Chandigarh, Punjab, India
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Kolkata, West Bengal, India
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Mangalore, , India
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Ashkelon, , Israel
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Haifa, , Israel
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Sefad, , Israel
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Tel Aviv, , Israel
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Milan, MI, Italy
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Roma, RM, Italy
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Gallarate, VA, Italy
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Napoli, , Italy
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Mexico City, Mexico City, Mexico
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Sittard-Geleen, BG, Netherlands
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gdansk, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Lodz, , Poland
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Guaynabo, , Puerto Rico
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Kemerovo, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saransk, , Russia
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Sestroretsk, , Russia
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Tyumen, , Russia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Nitra, , Slovakia
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Trnava, , Slovakia
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Cadiz, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Salt, Catalonia, Spain
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El Palmar, Murcia, Spain
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Barcelona, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Basel, , Switzerland
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Khon Kaen, THA, Thailand
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Headington, Oxfordshire, United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
Countries
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References
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Williams MJ, Amezcua L, Cohan SL, Cohen JA, Delgado SR, Hua LH, Lucassen EB, Piccolo RS, Koulouris CR, Stankiewicz J. Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups: ASCLEPIOS I/II Subgroup Analyses. Neurology. 2024 Aug 13;103(3):e209610. doi: 10.1212/WNL.0000000000209610. Epub 2024 Jul 17.
Bhan V, Clift F, Baharnoori M, Thomas K, Patel BP, Blanchette F, Adlard N, Vudumula U, Gudala K, Dutta N, Grima D, Mouallif S, Farhane F. Cost-consequence analysis of ofatumumab for the treatment of relapsing-remitting multiple sclerosis in Canada. J Comp Eff Res. 2023 Sep;12(9):e220175. doi: 10.57264/cer-2022-0175. Epub 2023 Aug 22.
Gartner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Haring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10.
Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Haring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-005418-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
COMB157G2301
Identifier Type: -
Identifier Source: org_study_id
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