Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

ClinicalTrials.gov Identifier: NCT03650114

Novartis Reference Number: COMB157G2399

Last Update: Apr 01, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

Condition 
Relapsing Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
2010 participants
Start date 
Nov 22, 2018
Completion date 
Oct 03, 2028
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
Ofatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks
Biological
Tetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
Biological
13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe
Biological
23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe
Biological
Seasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Biological
Keyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial

Eligibility Criteria

Inclusion Criteria:

Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
Written informed consent

Exclusion Criteria:

Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
Subjects taking medications prohibited by the protocol
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

Informed consent
Actively enrolled in the COMB157G2399 Study
12 weeks of continuous treatment within the COMB157G2399 Study
prior vaccination history as per protocol-defined

Exclusion criteria

known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
allergies to egg or shellfish
any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35233-0271
Alabama
United States
Novartis Investigative Site
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Cullman, 35058
Alabama
United States
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Phoenix, 85013
Arizona
United States
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Fullerton, 92835
California
United States
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Sacramento, 95817
California
United States
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Aurora, 80045
Colorado
United States
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Basalt, 81621
Colorado
United States
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Boulder, 80301
Colorado
United States
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Colorado Springs, 80907
Colorado
United States
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Denver, 80210
Colorado
United States
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Fort Collins, 80528
Colorado
United States
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Newark, 19713
Delaware
United States
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Atlantis, 33462-6608
Florida
United States
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Bradenton, 34205
Florida
United States
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Delray Beach, 33445
Florida
United States
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Maitland, 32751
Florida
United States
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Miami, 33032
Florida
United States
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Miami, 33136
Florida
United States
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Naples, 34102
Florida
United States
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Oldsmar, 34677
Florida
United States
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Ormond Beach, 32174
Florida
United States
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Pensacola, 32514
Florida
United States
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Port Charlotte, 33952
Florida
United States
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Sarasota, 34243
Florida
United States
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Sunrise, 33351
Florida
United States
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Tallahassee, 32312
Florida
United States
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Tampa, 33603
Florida
United States
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Tampa, 33609
Florida
United States
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Tampa, 33612
Florida
United States
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West Palm Beach, 33407
Florida
United States
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Savannah, 31406
Georgia
United States
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Suwanee, 30024
Georgia
United States
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Honolulu, 96817
Hawaii
United States
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Chicago, 60612
Illinois
United States
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Indianapolis, 46256
Indiana
United States
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Kansas City, 66160
Kansas
United States
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Overland Park, 66210
Kansas
United States
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Alexandria, 71301
Louisiana
United States
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Baton Rouge, 70810
Louisiana
United States
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Wellesley, 02481
Massachusetts
United States
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Detroit, 48201
Michigan
United States
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Detroit, 48202
Michigan
United States
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Chesterfield, 63017
Missouri
United States
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Ozark, 65721
Missouri
United States
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Saint Louis, 63110
Missouri
United States
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Billings, 59101
Montana
United States
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Great Falls, 59405
Montana
United States
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Las Vegas, 89106
Nevada
United States
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Albuquerque, 87131-0001
New Mexico
United States
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Latham, 12110
New York
United States
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Asheville, 28806
North Carolina
United States
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Charlotte, 28204
North Carolina
United States
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Greensboro, 27405
North Carolina
United States
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Raleigh, 27607
North Carolina
United States
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Winston-Salem, 27103
North Carolina
United States
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Akron, 44320
Ohio
United States
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Cleveland, 44195
Ohio
United States
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Columbus, 43214
Ohio
United States
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Westerville, 43081
Ohio
United States
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Oklahoma City, 73104
Oklahoma
United States
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Portland, 97225
Oregon
United States
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Willow Grove, 19090
Pennsylvania
United States
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Greer, 29650
South Carolina
United States
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Cordova, 38018
Tennessee
United States
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Johnson City, 37604
Tennessee
United States
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Knoxville, 37920
Tennessee
United States
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Knoxville, 37922
Tennessee
United States
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El Paso, 79935
Texas
United States
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Houston, 77074
Texas
United States
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Lubbock, 79410
Texas
United States
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Round Rock, 78681
Texas
United States
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San Antonio, 78258
Texas
United States
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Sherman, 75092
Texas
United States
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Salt Lake City, 84103
Utah
United States
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Salt Lake City, 84132
Utah
United States
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Virginia Beach, 23456
Virginia
United States
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Kirkland, 98034
Washington
United States
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Tacoma, 98405
Washington
United States
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Madison, 53792
Wisconsin
United States
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Milwaukee, 53215
Wisconsin
United States
Australia
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Liverpool, 2170
New South Wales
Australia
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New Lambton Heights, 2305
New South Wales
Australia
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St Leonards, 2065
New South Wales
Australia
Bulgaria
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Sofia, 1413
-
Bulgaria
Canada
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London, N6A 5A5
Ontario
Canada
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Ottawa, K1H 8L6
Ontario
Canada
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Toronto, M4N 3M5
Ontario
Canada
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Greenfield Park, J4V 2J2
Quebec
Canada
Croatia
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Rijeka, 51000
HRV
Croatia
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Osijek, 31000
-
Croatia
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Zagreb, 10000
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Croatia
France
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Nice, 06001
Cedex1
France
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Lille Cedex, 59037
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France
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Montpellier, 34295
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France
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Nantes Cedex 1, 44093
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France
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Nimes Cedex, 30029
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France
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Paris Cedex 13, 75651
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France
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Strasbourg, 67098
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France
Germany
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Dresden, 01307
-
Germany
Greece
Novartis Investigative Site
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Thessaloniki, GR 54636
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Greece
Peru
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Cercado De Lima, 01
Lima
Peru
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San Isidro, 27
Lima
Peru
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Lima, LIMA 13
-
Peru
Poland
Novartis Investigative Site
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Bydgoszcz, 85-796
Woj Kujawsko-pomorskie
Poland
Novartis Investigative Site
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Katowice, 40 571
-
Poland
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Kielce, 25 726
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Poland
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Rzeszow, 35 055
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Poland
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Warszawa, 02 957
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Poland
Portugal
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Coimbra, 3000 075
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Portugal
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Santa Maria da Feira, 4520 211
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Portugal
Russian Federation
Novartis Investigative Site
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Ekaterinburg, 620109
-
Russian Federation
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Kazan, 420021
-
Russian Federation
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Kemerovo, 650066
-
Russian Federation
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Krasnoyarsk, 660049
-
Russian Federation
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Moscow, 125367
-
Russian Federation
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Moscow, 127015
-
Russian Federation
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Nizhny Novgorod, 603137
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Russian Federation
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Nizhny Novgorod, 603155
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Russian Federation
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Novosibirsk, 630007
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Russian Federation
Novartis Investigative Site
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Novosibirsk, 630087
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Russian Federation
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Saint Petersburg, 194044
-
Russian Federation
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Saint Petersburg, 197022
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Russian Federation
Novartis Investigative Site
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Saransk, 430032
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Russian Federation
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Sestroretsk, 197706
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Russian Federation
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St Petersburg, 190000
-
Russian Federation
Novartis Investigative Site
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St. Petersburg, 197376
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Russian Federation
Novartis Investigative Site
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Tyumen, 625000
-
Russian Federation
Slovakia
Novartis Investigative Site
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Banska Bystrica, 975 17
-
Slovakia
Novartis Investigative Site
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Bratislava, 813 69
-
Slovakia
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Bratislava, 82606
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Slovakia
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Bratislava, 83305
-
Slovakia
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Nitra, 94901
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Slovakia
Novartis Investigative Site
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Trnava, 917 75
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Slovakia
South Africa
Novartis Investigative Site
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Pretoria, 0041
-
South Africa
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Rosebank, 2196
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South Africa
Spain
Novartis Investigative Site
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Cadiz, 11009
Andalucia
Spain
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Malaga, 29010
Andalucia
Spain
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Sevilla, 41017
Andalucia
Spain
Novartis Investigative Site
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Barcelona, 08003
Cataluna
Spain
Novartis Investigative Site
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Barcelona, 08026
Cataluna
Spain
Novartis Investigative Site
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Barcelona, 08035
Catalunya
Spain
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Barcelona, 08036
Catalunya
Spain
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L Hospitalet De Llobregat, 08907
Catalunya
Spain
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Salt, 17190
Cataluña
Spain
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Pozuelo de Alarcon, 28223
Madrid
Spain
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El Palmar, 30120
Murcia
Spain
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San Sebastian, 20080
Pais Vasco
Spain
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Castilleja de la cuesta, 41950
Sevilla
Spain
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Baracaldo, 48903
Vizcaya
Spain
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Madrid, 28006
-
Spain
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Madrid, 28034
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Spain
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Madrid, 28040
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Spain
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Madrid, 28222
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Spain
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Valencia, 46026
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Spain
Turkey
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Istanbul, 34147
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Turkey
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Kocaeli, 41380
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Turkey
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Mersin, 33079
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Turkey
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Samsun, 55139
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Turkey
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Trabzon, 61080
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Turkey
United Kingdom
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Luton, LU4 0DZ
Beds
United Kingdom
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Headington, OX3 9DU
Oxfordshire
United Kingdom
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Sheffield, S10 2JF
South Yorkshire
United Kingdom
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Glasgow, G51 4TF
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United Kingdom
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London, E1 1BB
-
United Kingdom
Novartis Investigative Site
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London, SW17 0QT
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United Kingdom

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