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

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ClinicalTrials.gov Identifier: NCT02792231
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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

Condition or disease Intervention/treatment Phase
Relapsing Multiple Scelrosis Drug: Ofatumumab subcutaneous injection Drug: Placebo orally matching to teriflunomide Drug: Teriflunomide orally Drug: Placebo subcutaneous injection matching to ofatumumab Phase 3

Detailed Description:

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
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.
Actual Study Start Date : August 26, 2016
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ofatumumab

Syringes for subcutaneous injection

Patients will also take a placebo capsule (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 subcutaneous injection matching to ofatumumab
Placebo-containing syringes, matching in appearance to syringes containing ofatumumab, administered every 4 weeks




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792231


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

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Locations
United States, Alabama
Novartis Investigative Site Active, not recruiting
Birmingham, Alabama, United States, 35233-0271
Novartis Investigative Site Active, not recruiting
Cullman, Alabama, United States, 35058
United States, Arizona
Novartis Investigative Site Withdrawn
Phoenix, Arizona, United States, 85018
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Tucson, Arizona, United States, 85704
Novartis Investigative Site Withdrawn
Tucson, Arizona, United States, 85718
United States, Colorado
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Aurora, Colorado, United States, 80045
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Basalt, Colorado, United States, 81621
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Boulder, Colorado, United States, 80301
Novartis Investigative Site Active, not recruiting
Centennial, Colorado, United States, 80112
Novartis Investigative Site Active, not recruiting
Colorado Springs, Colorado, United States, 80907
Novartis Investigative Site Active, not recruiting
Denver, Colorado, United States, 80210
Novartis Investigative Site Active, not recruiting
Fort Collins, Colorado, United States, 80528
Novartis Investigative Site Active, not recruiting
Fort Collins, Colorado, United States, 907-280528
United States, Connecticut
Novartis Investigative Site Completed
Fairfield, Connecticut, United States, 06824
United States, Delaware
Novartis Investigative Site Active, not recruiting
Newark, Delaware, United States, 19713
United States, Florida
Novartis Investigative Site Active, not recruiting
Bradenton, Florida, United States, 34205
Novartis Investigative Site Active, not recruiting
Gainesville, Florida, United States, 32611
Novartis Investigative Site Active, not recruiting
Maitland, Florida, United States, 32751
Novartis Investigative Site Active, not recruiting
Ocala, Florida, United States, 34471
Novartis Investigative Site Active, not recruiting
Oldsmar, Florida, United States, 34677
Novartis Investigative Site Withdrawn
Orlando, Florida, United States, 32806
Novartis Investigative Site Active, not recruiting
Ormond Beach, Florida, United States, 32174
Novartis Investigative Site Active, not recruiting
Palm Coast, Florida, United States, 32164
Novartis Investigative Site Completed
Saint Petersburg, Florida, United States, 33713
Novartis Investigative Site Active, not recruiting
Sarasota, Florida, United States, 34243
Novartis Investigative Site Active, not recruiting
Tallahassee, Florida, United States, 32312
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Tampa, Florida, United States, 33603
Novartis Investigative Site Active, not recruiting
Tampa, Florida, United States, 33609
Novartis Investigative Site Active, not recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Novartis Investigative Site Withdrawn
Atlanta, Georgia, United States, 30309
Novartis Investigative Site Withdrawn
Columbus, Georgia, United States, 31904
Novartis Investigative Site Active, not recruiting
Suwanee, Georgia, United States, 30024
United States, Illinois
Novartis Investigative Site Withdrawn
Chicago, Illinois, United States, 60611
Novartis Investigative Site Completed
Flossmoor, Illinois, United States, 60422
United States, Indiana
Novartis Investigative Site Active, not recruiting
Anderson, Indiana, United States, 46011
Novartis Investigative Site Active, not recruiting
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Novartis Investigative Site Withdrawn
Louisville, Kentucky, United States, 40207
United States, Maryland
Novartis Investigative Site Withdrawn
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Novartis Investigative Site Withdrawn
Foxboro, Massachusetts, United States, 02035
Novartis Investigative Site Withdrawn
Lexington, Massachusetts, United States, 02421
Novartis Investigative Site Active, not recruiting
Wellesley, Massachusetts, United States, 02481
Novartis Investigative Site Withdrawn
Worcester, Massachusetts, United States, 01655
United States, Michigan
Novartis Investigative Site Active, not recruiting
Detroit, Michigan, United States, 48202
Novartis Investigative Site Completed
Farmington Hills, Michigan, United States, 48334
Novartis Investigative Site Withdrawn
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Novartis Investigative Site Active, not recruiting
Golden Valley, Minnesota, United States, 55422
United States, Montana
Novartis Investigative Site Active, not recruiting
Billings Montana, Montana, United States, 59101
Novartis Investigative Site Active, not recruiting
Great Falls, Montana, United States, 59405
United States, Nebraska
Novartis Investigative Site Completed
Omaha, Nebraska, United States, 68198-2045
United States, New Hampshire
Novartis Investigative Site Withdrawn
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Novartis Investigative Site Completed
Freehold, New Jersey, United States, 07728
United States, New Mexico
Novartis Investigative Site Active, not recruiting
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
Novartis Investigative Site Completed
Plainview, New York, United States, 11803
United States, North Carolina
Novartis Investigative Site Active, not recruiting
Asheville, North Carolina, United States, 28806
Novartis Investigative Site Active, not recruiting
Charlotte, North Carolina, United States, 28202
Novartis Investigative Site Active, not recruiting
Greensboro, North Carolina, United States, 27405
Novartis Investigative Site Withdrawn
Hendersonville, North Carolina, United States, 28792
United States, Ohio
Novartis Investigative Site Active, not recruiting
Akron, Ohio, United States, 44320
Novartis Investigative Site Active, not recruiting
Columbus, Ohio, United States, 43214
Novartis Investigative Site Active, not recruiting
Columbus, Ohio, United States, 43221
Novartis Investigative Site Completed
Toledo, Ohio, United States, 43614
Novartis Investigative Site Withdrawn
Uniontown, Ohio, United States, 44685
Novartis Investigative Site Active, not recruiting
Westerville, Ohio, United States, 43081
United States, Oregon
Novartis Investigative Site Active, not recruiting
Portland, Oregon, United States, 97225
Novartis Investigative Site Withdrawn
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Novartis Investigative Site Completed
Hershey, Pennsylvania, United States, 17033-0850
Novartis Investigative Site Withdrawn
Philadelphia, Pennsylvania, United States, 19107-5098
Novartis Investigative Site Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15212
Novartis Investigative Site Active, not recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Novartis Investigative Site Active, not recruiting
Greer, South Carolina, United States, 29650
United States, Tennessee
Novartis Investigative Site Active, not recruiting
Cordova, Tennessee, United States, 38018
Novartis Investigative Site Active, not recruiting
Knoxville, Tennessee, United States, 37934
Novartis Investigative Site Active, not recruiting
Nashville, Tennessee, United States, 37205
Novartis Investigative Site Completed
Nashville, Tennessee, United States, 37212
United States, Texas
Novartis Investigative Site Active, not recruiting
Greenville, Texas, United States, 75401
Novartis Investigative Site Active, not recruiting
Lubbock, Texas, United States, 79410
Novartis Investigative Site Active, not recruiting
Sherman, Texas, United States, 75092
United States, Utah
Novartis Investigative Site Active, not recruiting
Orem, Utah, United States, 84058
Novartis Investigative Site Active, not recruiting
Salt Lake City, Utah, United States, 84103
Novartis Investigative Site Active, not recruiting
Salt Lake City, Utah, United States, 84132
United States, Washington
Novartis Investigative Site Active, not recruiting
Kirkland, Washington, United States, 98034
Novartis Investigative Site Withdrawn
Seattle, Washington, United States, 98101
Novartis Investigative Site Active, not recruiting
Seattle, Washington, United States, 98122
Novartis Investigative Site Completed
Seattle, Washington, United States, 98133
Novartis Investigative Site Active, not recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Novartis Investigative Site Active, not recruiting
Waukesha, Wisconsin, United States, 53188
Argentina
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina, C1181ACH
Novartis Investigative Site Active, not recruiting
Caba, Buenos Aires, Argentina, C1428AQK
Novartis Investigative Site Active, not recruiting
Rosario, Santa Fe, Argentina, S2000DSW
Novartis Investigative Site Active, not recruiting
Tucuman, Argentina, 4000
Australia, New South Wales
Novartis Investigative Site Withdrawn
Camperdown, New South Wales, Australia, 2050
Novartis Investigative Site Active, not recruiting
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Novartis Investigative Site Withdrawn
Melbourne, Victoria, Australia, 3050
Austria
Novartis Investigative Site Withdrawn
Innsbruck, Austria, 6020
Novartis Investigative Site Active, not recruiting
Vienna, Austria, 1010
Novartis Investigative Site Active, not recruiting
Vienna, Austria, 1090
Belgium
Novartis Investigative Site Active, not recruiting
Edegem, Antwerpen, Belgium, 2650
Novartis Investigative Site Active, not recruiting
Aalst, Belgium, 9300
Novartis Investigative Site Active, not recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Active, not recruiting
Gent, Belgium, 9000
Novartis Investigative Site Withdrawn
La Louviere, Belgium, 7100
Bulgaria
Novartis Investigative Site Active, not recruiting
Sofia, Bulgaria, 1113
Novartis Investigative Site Active, not recruiting
Sofia, Bulgaria, 1413
Canada, Ontario
Novartis Investigative Site Active, not recruiting
London, Ontario, Canada, N6A 5A5
Novartis Investigative Site Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Novartis Investigative Site Active, not recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Croatia
Novartis Investigative Site Active, not recruiting
Osijek, Croatia, 31000
Novartis Investigative Site Active, not recruiting
Zagreb, Croatia, 10000
Czechia
Novartis Investigative Site Active, not recruiting
Brno, Czech Republic, Czechia, 656 91
Novartis Investigative Site Active, not recruiting
Havirov, Czech Republic, Czechia, 736 01
Novartis Investigative Site Active, not recruiting
Teplice, Czech Republic, Czechia, 415 01
Novartis Investigative Site Active, not recruiting
Ostrava-Poruba, Czechia, 708 52
Novartis Investigative Site Active, not recruiting
Praha 10, Czechia, 100 34
Finland
Novartis Investigative Site Withdrawn
HUS, Finland, 00029
Novartis Investigative Site Active, not recruiting
Tampere, Finland, 33100
Novartis Investigative Site Active, not recruiting
Turku, Finland, 20520
Novartis Investigative Site Completed
Turku, Finland, 20521
France
Novartis Investigative Site Active, not recruiting
Nice, Cedex1, France, 06001
Novartis Investigative Site Active, not recruiting
Bordeaux Cedex, France, 33076
Novartis Investigative Site Completed
Clermont-Ferrand, France, 63000
Novartis Investigative Site Active, not recruiting
Montpellier, France, 34295
Novartis Investigative Site Active, not recruiting
Paris Cedex 13, France, 75651
Novartis Investigative Site Active, not recruiting
Rennes Cedex, France, 35033
Novartis Investigative Site Active, not recruiting
Strasbourg, France, 67098
Germany
Novartis Investigative Site Completed
Berlin, Germany, 10098
Novartis Investigative Site Withdrawn
Berlin, Germany, 12101
Novartis Investigative Site Active, not recruiting
Bochum, Germany, 44791
Novartis Investigative Site Withdrawn
Bonn, Germany, 53111
Novartis Investigative Site Active, not recruiting
Dresden, Germany, 01307
Novartis Investigative Site Completed
Erbach, Germany, 64711
Novartis Investigative Site Withdrawn
Erfurt, Germany, 99089
Novartis Investigative Site Withdrawn
Erlangen, Germany, 91054
Novartis Investigative Site Active, not recruiting
Essen, Germany, 45147
Novartis Investigative Site Active, not recruiting
Hamburg, Germany, 22179
Novartis Investigative Site Active, not recruiting
Hannover, Germany, 30623
Novartis Investigative Site Active, not recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Active, not recruiting
Homburg, Germany, 66421
Novartis Investigative Site Active, not recruiting
Koln, Germany, 50935
Novartis Investigative Site Active, not recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Active, not recruiting
Leipzig, Germany, 04107
Novartis Investigative Site Active, not recruiting
Minden, Germany, 32429
Novartis Investigative Site Active, not recruiting
Siegen, Germany, 57076
Novartis Investigative Site Active, not recruiting
Stuttgart, Germany, 70182
Novartis Investigative Site Active, not recruiting
Ulm, Germany, 89081
Novartis Investigative Site Recruiting
Unterhaching, Germany, 82008
Hungary
Novartis Investigative Site Completed
Budapest, HUN, Hungary, 1145
Novartis Investigative Site Active, not recruiting
Budapest, HUN, Hungary, 1204
Novartis Investigative Site Active, not recruiting
Esztergom, HUN, Hungary, 2500
Novartis Investigative Site Withdrawn
Pecs, Hungary, 7623
India
Novartis Investigative Site Active, not recruiting
Hyderabad, Andhra Pradesh, India, 500018
Novartis Investigative Site Active, not recruiting
New Delhi, Delhi, India, 110 060
Novartis Investigative Site Active, not recruiting
Mumbai, Maharashtra, India, 400008
Novartis Investigative Site Active, not recruiting
Mumbai, Maharashtra, India, 400012
Novartis Investigative Site Active, not recruiting
Pune, Maharashtra, India, 411004
Novartis Investigative Site Active, not recruiting
Ludhiana, Punjab, India, 141008
Novartis Investigative Site Active, not recruiting
Mumbai, India, 400016
Italy
Novartis Investigative Site Completed
Pozzilli, IS, Italy, 86077
Novartis Investigative Site Active, not recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00133
Novartis Investigative Site Active, not recruiting
Genova, Italy, 16132
Novartis Investigative Site Active, not recruiting
Milano, Italy, 20133
Novartis Investigative Site Active, not recruiting
Napoli, Italy, 80138
Novartis Investigative Site Active, not recruiting
Rome, Italy, 00178
Latvia
Novartis Investigative Site Active, not recruiting
Riga, LV, Latvia, LV-1005
Novartis Investigative Site Active, not recruiting
Riga, Latvia, LV 1002
Novartis Investigative Site Active, not recruiting
Riga, Latvia, LV-1038
Lithuania
Novartis Investigative Site Active, not recruiting
Kaunas, LTU, Lithuania, LT-50161
Novartis Investigative Site Active, not recruiting
Vilnius, Lithuania, LT-08661
Mexico
Novartis Investigative Site Withdrawn
San Luis Potosi, San Luis Potosí, Mexico, 78240
Novartis Investigative Site Active, not recruiting
Chihuahua, Mexico, 31238
Norway
Novartis Investigative Site Completed
Bergen, Norway, 5021
Novartis Investigative Site Active, not recruiting
Drammen, Norway, 1086
Novartis Investigative Site Completed
Stavanger, Norway, 4068
Peru
Novartis Investigative Site Active, not recruiting
Cercado De Lima, Lima, Peru, 01
Novartis Investigative Site Active, not recruiting
San Isidro, Lima, Peru, 27
Novartis Investigative Site Active, not recruiting
Lima, Peru, LIMA 13
Poland
Novartis Investigative Site Active, not recruiting
Glogow, Poland, 36-060
Novartis Investigative Site Withdrawn
Katowice, Poland, 40-648
Novartis Investigative Site Active, not recruiting
Rzeszow, Poland, 35 055
Novartis Investigative Site Active, not recruiting
Warszawa, Poland, 02-957
Novartis Investigative Site Active, not recruiting
Wroclaw, Poland, 51-685
Novartis Investigative Site Active, not recruiting
Zabrze, Poland, 41-800
Portugal
Novartis Investigative Site Active, not recruiting
Matosinhos, Porto, Portugal, 4454509
Novartis Investigative Site Active, not recruiting
Amadora, Portugal, 2720-276
Novartis Investigative Site Active, not recruiting
Braga, Portugal, 4710243
Novartis Investigative Site Active, not recruiting
Coimbra, Portugal, 3000-075
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1169-050
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1500 650
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1600190
Novartis Investigative Site Active, not recruiting
Loures, Portugal, 2674514
Novartis Investigative Site Active, not recruiting
Porto, Portugal, 4000001
Novartis Investigative Site Completed
Porto, Portugal, 4200 319
Novartis Investigative Site Active, not recruiting
Santa Maria Da Feira, Portugal, 4520211
Russian Federation
Novartis Investigative Site Active, not recruiting
Ekaterinburg, Russian Federation, 620102
Novartis Investigative Site Active, not recruiting
Kazan, Russian Federation, 420021
Novartis Investigative Site Active, not recruiting
Krasnoyarsk, Russian Federation, 660037
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 127015
Novartis Investigative Site Active, not recruiting
Nizhny Novgorod, Russian Federation, 603137
Novartis Investigative Site Active, not recruiting
Novosibirsk, Russian Federation, 630087
Novartis Investigative Site Active, not recruiting
Saint Petersburg, Russian Federation, 197022
Novartis Investigative Site Active, not recruiting
St. Petersburg, Russian Federation, 197110
Novartis Investigative Site Active, not recruiting
St. Petersburg, Russian Federation, 197376
Slovakia
Novartis Investigative Site Active, not recruiting
Bratislava, Slovakia, 813 69
Novartis Investigative Site Active, not recruiting
Martin, Slovakia, 036 59
Novartis Investigative Site Active, not recruiting
Ruzomberok, Slovakia, 03426
South Africa
Novartis Investigative Site Active, not recruiting
Pretoria, South Africa, 0041
Novartis Investigative Site Active, not recruiting
Rosebank, South Africa, 2196
Spain
Novartis Investigative Site Active, not recruiting
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site Active, not recruiting
Sevilla, Andalucia, Spain, 41017
Novartis Investigative Site Active, not recruiting
Pozuelo de Alarcon, Madrid, Spain, 28223
Novartis Investigative Site Active, not recruiting
Baracaldo, Vizcaya, Spain, 48903
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28006
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28034
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28040
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28222
Novartis Investigative Site Active, not recruiting
San Sebastian, Spain, 20014
Switzerland
Novartis Investigative Site Withdrawn
Aarau, Switzerland, 5001
Novartis Investigative Site Withdrawn
Bern, Switzerland, 3010
Novartis Investigative Site Active, not recruiting
Lugano, Switzerland, 6900
Taiwan
Novartis Investigative Site Terminated
Taichung, Taiwan, 40447
Novartis Investigative Site Active, not recruiting
Tainan, Taiwan, 70421
Turkey
Novartis Investigative Site Active, not recruiting
Haseki / Istanbul, Turkey, 34096
Novartis Investigative Site Active, not recruiting
Izmir, Turkey, 35340
Novartis Investigative Site Active, not recruiting
Mersin, Turkey, 33079
Novartis Investigative Site Active, not recruiting
Trabzon, Turkey, 61080
United Kingdom
Novartis Investigative Site Active, not recruiting
Luton, Beds, United Kingdom, LU4 0DZ
Novartis Investigative Site Withdrawn
Romford, Essex, United Kingdom, RM7 0AG
Novartis Investigative Site Active, not recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Novartis Investigative Site Active, not recruiting
London, United Kingdom, SE5 9RS
Novartis Investigative Site Active, not recruiting
London, United Kingdom, SW17 0QT
Novartis Investigative Site Withdrawn
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02792231     History of Changes
Other Study ID Numbers: COMB157G2302
2015-005419-33 ( EudraCT Number )
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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
Ofatumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs