An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod

ClinicalTrials.gov Identifier: NCT04353492

Novartis Reference Number: COMB157G23101

Last Update: Apr 26, 2022

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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

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Condition 
Relapsing Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jul 14, 2020
Completion date 
Jan 06, 2025
Gender 
All
Age(s)
18 Years - 60 Years (Adult)

Interventions

Biological
Ofatumumab
Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)

Eligibility Criteria

Inclusion Criteria:

Diagnosis of MS according to the 2017 Revised McDonald criteria
Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)
Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT
Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration
Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
Neurologically stable within one month prior to first study drug administration

Exclusion Criteria:

Subjects with primary progressive MS or SPMS without disease activity
Subjects meeting criteria for neuromyelitis optica
Disease duration of more than 10 years since diagnosis
Pregnant or nursing (lactating) women
Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication
Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)
Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice
Subjects with active hepatitis B and C disease, assessed locally
Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.)
Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator

Study Locations

United States
Novartis Investigative Site
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Cullman, 35058
Alabama
United States
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Tucson, 85718
Arizona
United States
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Fullerton, 92835
California
United States
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Los Angeles, 90033
California
United States
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Mountain View, 94040
California
United States
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San Diego, 92103
California
United States
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Aurora, 80045
Colorado
United States
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Colorado Springs, 80907
Colorado
United States
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Newark, 19713
Delaware
United States
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Hollywood, 33021
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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Sarasota, 34233
Florida
United States
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Sunrise, 33351
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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Atlanta, 30327
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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Indianapolis, 46256
Indiana
United States
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Baltimore, 21287
Maryland
United States
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Boston, 02114
Massachusetts
United States
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Foxboro, 02035
Massachusetts
United States
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Chesaning, 48616
Michigan
United States
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Detroit, 48202
Michigan
United States
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Golden Valley, 55422
Minnesota
United States
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Omaha, 68130
Nebraska
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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Woodmere, 11598
New York
United States
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Cincinnati, 45219
Ohio
United States
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Cleveland, 44195
Ohio
United States
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Westerville, 43082
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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Philadelphia, 19107-5098
Pennsylvania
United States
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Houston, 77030
Texas
United States
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Fairfax, 22030
Virginia
United States
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Milwaukee, 53215
Wisconsin
United States
Argentina
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Rosario, S2000BZL
Santa Fe
Argentina
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Rosario, S2000DSW
Santa Fe
Argentina
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Buenos Aires, 1061
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Argentina
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Tucuman, 4000
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Argentina
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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Woolloongabba, 4102
Queensland
Australia
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Heidelberg, 3084
Victoria
Australia
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Melbourne, 3004
Victoria
Australia
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Parkville, 3050
Victoria
Australia
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Nedlands, 6009
Western Australia
Australia
Austria
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Linz, A 4020
Oberoesterreich
Austria
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Linz, A-4020
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Austria
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Vienna, 1090
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Austria
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Wien, 1010
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Austria
Belgium
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Edegem, 2650
Antwerpen
Belgium
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Bonheiden, 2820
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Belgium
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Brugge, 8000
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Belgium
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Bruxelles, 1200
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Belgium
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Esneux, 4130
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Belgium
Bulgaria
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Pleven, 5800
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Bulgaria
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Sofia, 1113
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Bulgaria
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Sofia, 1413
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Bulgaria
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Sofia, 1431
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Bulgaria
Canada
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Burnaby, V5G 2X6
British Columbia
Canada
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Toronto, M4N 3M5
Ontario
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Czech Republic
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Brno, 656 91
Czech Republic
Czech Republic
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Havirov, 736 01
Czech Republic
Czech Republic
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Teplice, 415 01
Czech Republic
Czech Republic
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Hradec Kralove, 500 05
CZE
Czech Republic
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Praha, 12808
-
Czech Republic
Estonia
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Tallinn, 11315
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Estonia
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Tartu, 51014
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Estonia
Germany
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Regensburg, 93053
Bavaria
Germany
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Bielefeld, D 33647
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Germany
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Cottbus, 03048
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Germany
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Erlangen, 91054
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Germany
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Heidelberg, 69120
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Germany
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Koln, 50935
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Germany
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Leipzig, 04275
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Germany
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Muenchen, 81377
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Germany
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Osnabrück, 49076
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Germany
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Potsdam, 14471
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Germany
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Siegen, 57076
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Germany
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Ulm, 89073
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Germany
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Ulm, 89081
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Germany
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Westerstede/Oldenburg, 26655
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Germany
Greece
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Larissa, 411 10
GR
Greece
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Thessaloniki, 54645
GR
Greece
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Thessaloniki, 53246
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Greece
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Thessaloniki, GR 54636
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Greece
Hungary
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Budapest, 1135
HUN
Hungary
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Budapest, 1204
HUN
Hungary
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Tatabanya, 2800
Komarom Esztergom
Hungary
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Pecs, 7623
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Hungary
Italy
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Firenze, 50134
FI
Italy
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Pavia, 27100
PV
Italy
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Roma, 00152
RM
Italy
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Verona, 37134
VR
Italy
Latvia
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Riga, LV-1005
LV
Latvia
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Riga, LV 1002
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Latvia
Lebanon
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Ashrafieh, 166830
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Lebanon
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Beirut, 1107 2020
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Lebanon
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Beirut,
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Lebanon
Mexico
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Ciudad de Mexico, 06700
Distrito Federal
Mexico
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Mexico, 03100
Distrito Federal
Mexico
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Morelia, 58260
Michoacan
Mexico
Norway
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Bergen, 5021
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Norway
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Drammen, 1086
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Norway
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Oslo, NO 0450
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Norway
Poland
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Bydgoszcz, 85-796
Woj Kujawsko-pomorskie
Poland
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Katowice, 40 571
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Poland
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Kielce, 25 726
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Poland
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Lodz, 90-153
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Poland
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Wroclaw, 51-685
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Poland
Portugal
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Braga, 4710243
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Portugal
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Lisboa, 1349-019
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Portugal
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Loures, 2674514
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Portugal
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Porto, 4099-001
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Portugal
Russian Federation
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Moscow, 115516
-
Russian Federation
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Moscow, 127015
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Russian Federation
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St Petersburg, 190000
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Russian Federation
Saudi Arabia
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Riyadh, 11525
SAU
Saudi Arabia
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Jeddah, 21499
-
Saudi Arabia
Slovakia
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Kosice, 04066
Slovak Republic
Slovakia
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Banska Bystrica, 975 17
-
Slovakia
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Bratislava, 813 69
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Slovakia
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Bratislava, 82606
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Slovakia
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Bratislava, 83305
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Slovakia
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Nitra, 94901
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Slovakia
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Trnava, 917 75
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Slovakia
Slovenia
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Ljubljana, 1000
-
Slovenia
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Maribor, 2000
-
Slovenia
Spain
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Sevilla, 41009
Andalucia
Spain
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Barcelona, 08026
Cataluna
Spain
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Valencia, 46010
Comunidad Valenciana
Spain
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El Palmar, 30120
Murcia
Spain
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Vigo, 36212
Pontevedra
Spain
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Baracaldo, 48903
Vizcaya
Spain
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Madrid, 28040
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Spain
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Santa Cruz de Tenerife, 38009
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Spain
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Valencia, 46026
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Spain
Switzerland
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Basel, 4031
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Switzerland
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Lugano, 6900
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Switzerland
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St Gallen, 9007
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Switzerland
Turkey
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Sancaktepe, 34785
Istanbul
Turkey
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Istanbul, 34098
TUR
Turkey
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Izmir, 35040
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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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Swansea,
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United Kingdom

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