A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.
NCT ID: NCT02752776
Last Updated: 2019-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1660 participants
INTERVENTIONAL
2016-03-17
2018-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Secukinumab
All patients are received s.c. injections of secukinumab 300 mg at Week 0, 1, 2 and 3 during the first 4 weeks followed by monthly maintenance dosing of 300 mg secukinumab starting at Week 4 until Week 48. Consideration was given to discontinuing treatment in patients who showed no response up to 16 weeks of treatment (e.g. patients who did not achieve a PASI 50 response). If discontinued, patients completed the end of study visit assessments. Some patients with an initially partial response (e.g. patients who achieved a PASI 50 response but not a PASI 75 response) subsequently improved with continued treatment beyond 16 weeks.
Secukinumab
Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).
Interventions
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Secukinumab
Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe plaque-type psoriasis diagnosed for at least 3 months prior to Screening and candidate for systemic therapy.
Exclusion Criteria
* Patients with previous treatment with any agent targeting interleukin (IL)-17 directly or IL-17 receptor A (e.g. secukinumab, ixekizumab, or brodalumab).
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they use effective contraception
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Geel, BEL, Belgium
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Bruges, , Belgium
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Ghent, , Belgium
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Seraing, , Belgium
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Ústí nad Labem, Czech Republic, Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Le Mans, Cedex 09, France
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Toulon, Val De Marne, France
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Angers, , France
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Antony, , France
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Argenteuil, , France
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Auxerre, , France
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Bayonne, , France
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Bordeaux, , France
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Boulogne-sur-Mer, , France
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Brest, , France
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Caen, , France
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Cannes, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Grenoble, , France
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La Rochelle, , France
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Lille, , France
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Marseille, , France
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Martigues, , France
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Montpellier, , France
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Nice, , France
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Nîmes, , France
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Pierre-Bénite, , France
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Pringy, , France
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Quimper, , France
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Reims, , France
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Rouen, , France
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Saint-Mandé, , France
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Saint-Priest-en-Jarez, , France
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Toulouse, , France
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Valence, , France
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Valenciennes, , France
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Vandœuvre-lès-Nancy, , France
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Mannheim, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Aachen, , Germany
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Andernach, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bonn, , Germany
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Bramsche, , Germany
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Braunschweig, , Germany
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Cologne, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Friedrichshafen, , Germany
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Gelsenkirchen, , Germany
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Gera, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Ibbenbueren, , Germany
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Kiel, , Germany
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Ludwigshafen am Rhein, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Münster, , Germany
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Osnabrück, , Germany
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Pommelsbrunn, , Germany
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Quedlinburg, , Germany
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Recklinghausen, , Germany
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Schwerin, , Germany
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Simmern, , Germany
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Vechta, , Germany
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Wiesbaden, , Germany
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Heraklion Crete, Greece, Greece
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Athens, GR, Greece
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Pátrai, , Greece
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Afula, , Israel
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Beersheba, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Arezzo, AR, Italy
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Bergamo, BG, Italy
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San Donato Milanese, MI, Italy
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Modena, MO, Italy
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Perugia, PG, Italy
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Siena, SI, Italy
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Varese, VA, Italy
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Daugavpils, LVA, Latvia
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Jelgava, LVA, Latvia
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Riga, LVA, Latvia
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Ventspils, LVA, Latvia
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, LTU, Lithuania
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Klaipėda, LTU, Lithuania
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Ossy, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Brasov, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Craiova, , Romania
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Iași, , Romania
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Malacky, Slovak Republic, Slovakia
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Bardejov, SVK, Slovakia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Svidník, , Slovakia
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Žilina, , Slovakia
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Ferrol, A Coruna, Spain
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Vitoria-Gasteiz, Alava, Spain
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Elda, Alicante, Spain
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Almería, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Sabadell, Barcelona, Spain
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Barakaldo, Basque Country, Spain
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Bilbao, Basque Country, Spain
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Jerez de la Frontera, Cadiz, Spain
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Ávila, Castille and León, Spain
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Valladolid, Castille and León, Spain
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Albacete, Castille-La Mancha, Spain
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Guadalajara, Castille-La Mancha, Spain
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Toledo, Castille-La Mancha, Spain
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Lleida, Catalonia, Spain
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Tarragona, Catalonia, Spain
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Terrassa, Catalonia, Spain
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Zamora, Espana, Spain
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A Coruña, Galicia, Spain
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Lugo, Galicia, Spain
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Ourense, Galicia, Spain
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Alcalá de Henares, Madrid, Spain
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Aranjuez, Madrid, Spain
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Fuenlabrada, Madrid, Spain
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Getafe, Madrid, Spain
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Leganés, Madrid, Spain
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Torrejón de Ardoz, Madrid, Spain
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Móstoles, Madrid, Communidad de, Spain
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Vigo, Pontevedra, Spain
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Breña Alta, Santa Cruz De Tenerife, Spain
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Talavera de la Reina, Toledo, Spain
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Alicante, Valencia, Spain
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Alicante, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Burgos, , Spain
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Granada, , Spain
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Granollers, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Zaragoza, , Spain
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Penzance, Cornwall, United Kingdom
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Harlow, Essex, United Kingdom
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Rothwell, GBR, United Kingdom
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Burbage, Leicester, United Kingdom
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Harrow, Middlesex, United Kingdom
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Bury Saint Edmonds, Suffolk, United Kingdom
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Bradford, West Yorkshire, United Kingdom
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Bath, , United Kingdom
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Bristol, , United Kingdom
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Chippenham, , United Kingdom
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Devon, , United Kingdom
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Durham, , United Kingdom
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East Sussex, , United Kingdom
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Exeter, , United Kingdom
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Lancaster, , United Kingdom
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London, , United Kingdom
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Middlesex, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Watford, , United Kingdom
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Wellingborough, , United Kingdom
Countries
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References
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Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
da Silva N, Sommer R, Ortmann CE, Jagiello P, Bachhuber T, Augustin M. Secukinumab effects on disease burden, patient needs and benefits, and treatment satisfaction in patients with plaque psoriasis across European regions: patient perspective data from the PROSE study. J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2241-2249. doi: 10.1111/jdv.17525. Epub 2021 Jul 31.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003701-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A3401
Identifier Type: -
Identifier Source: org_study_id
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