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Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02792218
First received: June 2, 2016
Last updated: September 19, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Relapsing Multiple Sclerosis Drug: Ofatumumab subcutaneous injection Drug: Placebo orally matching to teriflunomide Drug: Teriflunomide orally Drug: Placebo subcutanous injection matching to ofatumumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Annualized relapse rate (ARR) [ Time Frame: up to 2.5 years ]
    ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient


Secondary Outcome Measures:
  • Time to 3-month confirmed disability worsening on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]
    A 3-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3 months.

  • Time to 6-month confirmed disability worsening on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]
    A 6-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 6 months.

  • Time to 6-month confirmed disability improvement on EDSS [ Time Frame: Baseline, every 3 months up to 2.5 years ]
    A 6-month confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months.

  • Number of gadolinium (Gd)-enhancing lesions per MRI scan [ Time Frame: Baseline, yearly up to 2.5 years ]
    Total number of Gd-enhancing lesions across all scans per patient adjusted for different number of scans due to variable follow up time in study

  • Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate) [ Time Frame: Baseline, yearly up to 2.5 years ]
    Number of new/enlarging T2 lesions on last available MRI scan compared to baseline adjusted for different time of scans versus baseline due to variable follow up time in study

  • Rate of brain volume loss based on assessments of percentage brain volume change from baseline [ Time Frame: Baseline, yearly up to 2.5 years ]
    Percent change from baseline in brain volume loss (BVL) on all MRI scans adjusted for different time of scan versus baseline due to variable follow up time in study


Estimated Enrollment: 900
Actual Study Start Date: September 19, 2016
Estimated Study Completion Date: July 1, 2019
Estimated Primary Completion Date: May 15, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab

Syringes for subcutaneous injection

Patients will also take a placebo capsules (matching in appearance to teriflunomide)

Drug: Ofatumumab subcutaneous injection
Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab every 4 weeks
Drug: Placebo orally matching to teriflunomide
Placebo orally, matching in appearance to teriflunomide, administered once daily
Active Comparator: Teriflunomide

Oral capsule

Patients will also take subcutaneous injections of placebo (syringes matching in appearance to ofatumumab)

Drug: Teriflunomide orally
Patients randomized to the teriflunomide arm will take teriflunomide orally once daily
Other Name: Aubagio
Drug: Placebo subcutanous injection matching to ofatumumab
Placebo-containing syringes, matching in appearance to syringes containing ofatumumab, administered every 4 weeks

Detailed Description:

This is a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multi-center 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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02792218

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

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Locations
United States, Alabama
Novartis Investigative Site Recruiting
Mobile, Alabama, United States, 36606
United States, Arizona
Novartis Investigative Site Active, not recruiting
Phoenix, Arizona, United States, 85004
Novartis Investigative Site Active, not recruiting
Phoenix, Arizona, United States, 85013
United States, California
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Berkeley, California, United States, 94705
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Carmichael, California, United States, 95670
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Fullerton, California, United States, 92835
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Sacramento, California, United States, 95817
United States, District of Columbia
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Washington, D.C., District of Columbia, United States, 20007
United States, Florida
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Atlantis, Florida, United States, 33462-6608
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Delray Beach, Florida, United States, 33445
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Hollywood, Florida, United States, 33021
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Loxahatchee Groves, Florida, United States, 33470
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Miami, Florida, United States, 33032
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Miami, Florida, United States, 33136
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Naples, Florida, United States, 34102
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North Palm Beach, Florida, United States, 33408
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Pensacola, Florida, United States, 32514
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Pompano Beach, Florida, United States, 33060
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Port Charlotte, Florida, United States, 33952
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Vero Beach, Florida, United States, 32960
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West Palm Beach, Florida, United States, 33407
United States, Georgia
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Savannah, Georgia, United States, 31406
United States, Hawaii
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Honolulu, Hawaii, United States, 96817
United States, Illinois
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Chicago, Illinois, United States, 60612
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Northbrook, Illinois, United States, 60062
United States, Indiana
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Indianapolis, Indiana, United States, 46202
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Indianapolis, Indiana, United States, 46260
United States, Iowa
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Des Moines, Iowa, United States, 50314-2611
United States, Kansas
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Kansas City, Kansas, United States, 66160
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Lenexa, Kansas, United States, 66214
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Overland Park, Kansas, United States, 66210
United States, Louisiana
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Alexandria, Louisiana, United States, 71301
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Baton Rouge, Louisiana, United States, 70810
United States, Massachusetts
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New Bedford, Massachusetts, United States, 02740
United States, Michigan
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Clinton, Michigan, United States, 48035
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Detroit, Michigan, United States, 48201
United States, Minnesota
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Golden Valley, Minnesota, United States, 55422
United States, Missouri
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Chesterfield, Missouri, United States, 63017
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Ozark, Missouri, United States, 65721
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Saint Louis, Missouri, United States, 63110
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Saint Louis, Missouri, United States, 63131
United States, Nevada
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Las Vegas, Nevada, United States, 89106
United States, New York
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Latham, New York, United States, 12110
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Stony Brook, New York, United States, 11794
United States, North Carolina
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Charlotte, North Carolina, United States, 28204
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Charlotte, North Carolina, United States, 28207
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Raleigh, North Carolina, United States, 27607
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Winston-Salem, North Carolina, United States, 27103
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Winston-Salem, North Carolina, United States, 27157
United States, Ohio
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Canton, Ohio, United States, 44718
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Cleveland, Ohio, United States, 44195
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
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Spartanburg, South Carolina, United States, 29303
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Spartanburg, South Carolina, United States, 29307
United States, Tennessee
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Johnson City, Tennessee, United States, 37604
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Knoxville, Tennessee, United States, 37920
United States, Texas
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Dallas, Texas, United States, 75246
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El Paso, Texas, United States, 79935
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Houston, Texas, United States, 77074
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Round Rock, Texas, United States, 78681
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78258
United States, Virginia
Novartis Investigative Site Withdrawn
Charlottesville, Virginia, United States, 22904
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Virginia Beach, Virginia, United States, 23456
United States, Wisconsin
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Green Bay, Wisconsin, United States, 54311
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Madison, Wisconsin, United States, 53792
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Milwaukee, Wisconsin, United States, 53211
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Milwaukee, Wisconsin, United States, 53215
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Neenah, Wisconsin, United States, 54956
Argentina
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Capital Federal, Buenos Aires, Argentina, 1424
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Trelew, Chubut, Argentina, U9100IEH
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Rosario, Santa Fe, Argentina, S2000BZL
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Buenos Aires, Argentina, 1061
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Cordoba, Argentina, X5004CDT
Australia, New South Wales
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New Lambton Heights, New South Wales, Australia, 2305
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St Leonards, New South Wales, Australia, 2065
Australia, Victoria
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Heidelberg, Victoria, Australia, 3084
Belgium
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Brasschaat, Belgium, 2930
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Brugge, Belgium, 8000
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Leuven, Belgium, 3000
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Lodelinsart, Belgium, 6042
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Overpelt, Belgium, 3900
Bulgaria
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1309
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Sofia, Bulgaria, 1431
Canada, British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z3
Canada, Quebec
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Gatineau, Quebec, Canada, J9J 0A5
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Montreal, Quebec, Canada, H3A 2BA
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Québec, Quebec, Canada, G1J 1Z4
Croatia
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Rijeka, Croatia, 51000
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Zagreb, Croatia, 10000
Czechia
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Praha 4 Krc, Czech Republic, Czechia, 140 59
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Hradec Kralove, CZE, Czechia, 500 05
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JIhlava, Czechia, 586 01
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Pardubice, Czechia, 532 03
Denmark
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Aarhus, Denmark, DK-8000
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Copenhagen, Denmark, DK-2100
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Odense C, Denmark, 5000
Estonia
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Tallinn, Estonia, 10617
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Tartu, Estonia, 51014
France
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Nancy, Cedex, France, 54035
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Bron, France, 69677
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CAEN Cedex, France, 14033
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Lille Cedex, France, 59037
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Nantes Cedex 1, France, 44093
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Nimes Cedex, France, 30029
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Paris, France, 75012
Germany
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Aschaffenburg, Germany, 63739
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Barsinghausen, Germany, 30890
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Bayreuth, Germany, 95445
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Berg, Germany, 82335
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Berlin, Germany, 13465
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Bielefeld, Germany, D 33647
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Duesseldorf, Germany, 40225
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Freiburg, Germany, 79106
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Hamburg, Germany, 20099
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Hamburg, Germany, 20249
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Hamburg, Germany, 22083
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Hannover, Germany, 30161
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Marburg, Germany, 35043
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Muenchen, Germany, 81377
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Muenchen, Germany, 81675
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Munster, Germany, 48149
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Neuburg an der Donau, Germany, 86633
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Potsdam, Germany, 14471
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Regensburg, Germany, 93053
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Ulm, Germany, 89073
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Wiesbaden, Germany, 65191
Greece
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Athens, Greece, 11525
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Athens, Greece, 11528
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Thessaloniki, Greece, 540 06
Hungary
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Budapest, Hungary, 1106
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Budapest, Hungary, 1135
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Kistarcsa, Hungary, 2143
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Szeged, Hungary, 6725
India
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New Delhi, Delhi, India, 110017
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Kochi, Kerala, India, 682 026
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Chandigarh, Punjab, India, 160012
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Kolkata, West Bengal, India, 700068
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Mangalore, India, 575018
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New Delhi, India, 110 029
Israel
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Ashkelon, Israel, 78278
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Haifa, Israel, 310 9601
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Sefad, Israel, 13100
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Tel Aviv, Israel, 64239
Italy
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Milano, MI, Italy, 20132
Netherlands
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Geleen, BG, Netherlands, 6162 BG
Novartis Investigative Site Active, not recruiting
Amsterdam, Netherlands, 1081 HV
Poland
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Bydgoszcz, Poland, 85-795
Novartis Investigative Site Recruiting
Gdansk, Poland, 80 952
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Gdansk, Poland, 80-462
Novartis Investigative Site Recruiting
Gdansk, Poland, 80-803
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Katowice, Poland, 40-595
Novartis Investigative Site Active, not recruiting
Kielce, Poland, 25-726
Novartis Investigative Site Recruiting
Lodz, Poland, 90-324
Puerto Rico
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Guaynabo, Puerto Rico, 00968
Russian Federation
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Kemerovo, Russian Federation, 650066
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Moscow, Russian Federation, 125367
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Nizhny Novgorod, Russian Federation, 603155
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Novosibirsk, Russian Federation, 630007
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Saint-Petersburg, Russian Federation, 194044
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Saransk, Russian Federation, 430032
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St. Petersburg, Russian Federation, 197706
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Tyumen, Russian Federation, 625048
Slovakia
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Bratislava, Slovakia, 82606
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 83305
Novartis Investigative Site Recruiting
Trnava, Slovakia, 917 75
Spain
Novartis Investigative Site Active, not recruiting
Cadiz, Andalucía, Spain, 11009
Novartis Investigative Site Recruiting
Barcelona, Cataluna, Spain, 08026
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Barcelona, Cataluna, Spain, 08036
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Barcelona, Catalunya, Spain, 08035
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L'Hospitalet de Llobregat, Catalunya, Spain, 08907
Novartis Investigative Site Recruiting
Salt, Cataluña, Spain, 17190
Novartis Investigative Site Recruiting
Alicante, Comunidad Valenciana, Spain, 03010
Novartis Investigative Site Recruiting
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Recruiting
Barcelona, Spain, 08003
Novartis Investigative Site Recruiting
Valencia, Spain, 46026
Sweden
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Goeteborg, Sweden, 413 45
Novartis Investigative Site Recruiting
Stockholm, Sweden, 17176
Switzerland
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Basel, Switzerland, 4031
Novartis Investigative Site Recruiting
Luzern, Switzerland, 6000
Thailand
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Khon Kaen, THA, Thailand, 40002
Novartis Investigative Site Recruiting
Chiang Mai, Thailand, 50200
Turkey
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Istanbul, Turkey, 34147
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
Novartis Investigative Site Recruiting
Kocaeli, Turkey, 41380
Novartis Investigative Site Recruiting
Samsun, Turkey, 55139
United Kingdom
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Headington, Oxfordshire, United Kingdom, OX3 9DU
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Glasgow, United Kingdom, G51 4TF
Novartis Investigative Site Recruiting
London, United Kingdom, E1 1BB
Novartis Investigative Site Recruiting
London, United Kingdom, W8 6RF
Novartis Investigative Site Recruiting
Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02792218     History of Changes
Other Study ID Numbers: COMB157G2301
2015-005418-31 ( EudraCT Number )
Study First Received: June 2, 2016
Last Updated: September 19, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Relapsing multiple sclerosis
Ofatumumab

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017