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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03982394
Other study ID # P19-377
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date July 30, 2025

Study information

Verified date June 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2439
Est. completion date July 30, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a specialist and presence of moderate to severe psoriasis symptoms according to physician's judgement at time of recruitment. - Participant starting any approved treatment for psoriasis and physician's decision must be reached prior to recruitment in the study. - Participant willing to continue with study documentation after cessation of therapy. Exclusion Criteria: - Unwillingness or inability to comply with study requirements. - Participation in an interventional clinical trial, concurrently or within the last 30 days. Participation in a post-market observational study (PMOS) or Registry is acceptable.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Professional Skin Care /ID# 218514 Buenos Aires
Argentina Hospital Italiano /ID# 217000 Caba
Argentina Private Office Cristina Echeverria /ID# 222082 Ciudad Autonoma Buenos Aires
Argentina Stringa Dermatologia /ID# 218450 Ciudad Autonoma Buenos Aires Ciudad Autonoma De Buenos Aires
Argentina Buenos Aires Skin /ID# 217657 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina CEDIC Centro de Investigaciones Clinicas /ID# 217184 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina Instituto de Neumonologia y Dermatologia /ID# 217429 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina Psoriahue Med Interdisciplinar /ID# 217182 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina Stat Research /ID# 217185 Ciudad Autonoma de Buenos Aire Ciudad Autonoma De Buenos Aires
Argentina Emiliano Baccarini Priv Practice /ID# 218581 Lomas de Zamora Buenos Aires
Argentina Hospital Universitario Austral /ID# 217540 Pilar Buenos Aires
Australia Skin Health Institute Inc /ID# 217619 Carlton Victoria
Australia Northern Dermatology /ID# 218374 Chermside Queensland
Australia Fremantle Dermatology /ID# 217617 Fremantle Western Australia
Australia Premier Specialist /ID# 218158 Kogarah New South Wales
Australia Kingsway Dermatology & Aesthetics /ID# 217616 Miranda New South Wales
Australia Veracity Clinical Research /ID# 217618 Woolloongabba Queensland
Austria Hautarzt Dr. Lukas Kraus /ID# 216139 Dornbirn Vorarlberg
Austria Medizinische Universitaet Graz /ID# 217702 Graz Steiermark
Austria Haut Trattner Dermatologie /ID# 216138 Hainfeld
Austria EZW HAUT Entzuendungszentrum Wien /ID# 215488 Vienna Wien
Austria Klinik Donaustadt /ID# 218842 Vienna Wien
Austria Klinik Hietzing /ID# 217685 Vienna Wien
Austria Klinik Landstrasse /ID# 217684 Vienna Wien
Austria Medizin am Hauptbahnhof /ID# 218837 Vienna Wien
Austria Klinikum Wels-Grieskirchen GmbH /ID# 216140 Wels Oberoesterreich
Canada CCA Medical Research /ID# 214446 Ajax Ontario
Canada SimcoDerm Medical and Surgical Dermatology Center /ID# 213081 Barrie Ontario
Canada SKIN Clinics /ID# 213082 Brandon Manitoba
Canada Beacon Dermatology Inc /ID# 213524 Calgary Alberta
Canada Alberta DermaSurgery Centre /ID# 230114 Edmonton Alberta
Canada Duplicate_Stratica Medical /ID# 213526 Edmonton Alberta
Canada Dr. Irina Turchin PC Inc. /ID# 212128 Fredericton New Brunswick
Canada Dermatrials Research /ID# 213523 Hamilton Ontario
Canada Hamilton Health Sciences Corporation /ID# 214053 Hamilton Ontario
Canada LEADER Research /ID# 249701 Hamilton Ontario
Canada Lima's Excellence in Allergy and Dermatology Research Inc /ID# 231973 Hamilton Ontario
Canada Clinique D /ID# 212126 Laval Quebec
Canada Lynde Institute for Dermatology /ID# 212124 Markham Ontario
Canada Al-Mohammedi Medicine Professional Corporation /ID# 215408 Mississauga Ontario
Canada DermEdge Research Inc. /ID# 213525 Mississauga Ontario
Canada Angela Montgomery Medicine Professional Corporation /ID# 213615 Ottawa Ontario
Canada Dr Melinda Gooderham Medicine Professional Corporation /ID# 212133 Peterborough Ontario
Canada Centre de Recherche St-Louis /ID# 216325 Quebec City Quebec
Canada Dr. Brown-Maher PMC INC. /ID# 212136 St. John's Newfoundland and Labrador
Canada Karma Clinical Trials /ID# 213522 St. John's Newfoundland and Labrador
Canada NewLab Clinical Research Inc. /ID# 213521 St. John's Newfoundland and Labrador
Canada Farheen Mussani Medicine Professional Corporation /ID# 213811 Stoney Creek Ontario
Canada North York Research Inc /ID# 213486 Toronto Ontario
Canada University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 213507 Vancouver British Columbia
Canada Private Practice - Dr. Kim Papp Clinical Research /ID# 212130 Waterloo Ontario
Canada Dr Maksym Breslavets Medicine Professional Corporation /ID# 213338 Whitby Ontario
Canada Winnipeg Clinic /ID# 212134 Winnipeg Manitoba
Colombia Ciensalud IPS S.A.S /ID# 244608 Barranqulla
Colombia Sociedad de Cirugía de Bogotá- Hospital de San José /ID# 222683 Bogota Cundinamarca
Colombia Caja de Compensación Familiar Cafam, Sede Centro de Atención En Salud Cafam Flor /ID# 222660 Bogotá Cundinamarca
Colombia Centro Dermatológico Federico Lleras Acosta E.S.E /ID# 222686 Bogotá Cundinamarca
Colombia Clinisalud del sur /ID# 222685 Medellin Antioquia
Colombia IPS Universitaria /ID# 241832 Medellin Antioquia
Colombia Fundacion hospitalaria San Vicente de Paul /ID# 222680 Medellín Antioquia
Colombia Fundacion Hospital Universidad del Norte /ID# 223428 Soledad Atlantico
Colombia Healthy Medical Center S.A.S /ID# 231909 Zipaquirá Cundinamarca
Czechia Nemocnice Ceske Budejovice a.s. /ID# 216310 Ceske Budejovice
Czechia Fakultni nemocnice Hradec Kralove /ID# 222670 Hradec Kralove
Czechia Fakultni nemocnice Olomouc /ID# 215901 Olomouc
Czechia Duplicate_Fakultni Nemocnice v Motole /ID# 215484 Prague
Czechia Fakultni nemocnice Kralovske Vinohrady /ID# 233184 Praha
Czechia Sanatorium profesora Arenbergera /ID# 215489 Praha
France CH du Pays d'AIX /ID# 216440 Aix En Provence Cedex 1
France CHU Amiens-Picardie Site Sud /ID# 216170 Amiens CEDEX 1 Somme
France Chu Angers /Id# 216244 Angers
France Ch Auxerre /Id# 216175 Auxerre Yonne
France Hopital Ambroise Pare /ID# 216439 Boulogne Billancourt
France Hopital de la Cavale Blanche /ID# 216495 Brest Finistere
France CHU de CAEN - Hopital de la Cote de Nacre /ID# 216245 Caen
France Cabinet Dermatologie et Esthetique /ID# 229132 Cannes
France CH William Morey /ID# 225441 Chalon Sur Saone
France Ch Chalons En Champagne /Id# 216668 Chalons en Champagne Marne
France Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 217572 Chambery CEDEX Savoie
France CHU Dijon /ID# 216247 Dijon Cote-d Or
France CH Annecy Genevois - Site Annecy /ID# 225786 Epagny Metz Tessy
France CHU Grenoble - Hopital Michallon /ID# 218437 La Tronche Isere
France Centre Hospitalier du Mans /ID# 225729 Le Mans CEDEX 9 Sarthe
France C.H. de Bretagne Sud /ID# 216243 Lorient
France Hopital Saint Joseph /ID# 223149 Marseille Bouches-du-Rhone
France CH Georges Renon /ID# 216174 Niort CEDEX Deux-Sevres
France CH Pontoise - Hopital René Dubos /ID# 216169 Pontoise Val-d Oise
France CHU de Rennes - PONTCHAILLOU /ID# 218248 Rennes Bretagne
France Hopitaux Drome Nord /ID# 222586 Romans Sur Isere Drome
France Hôpital d'instruction des armées Bégin /ID# 216167 Saint-Mandé cedex
France Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 216663 St-Priest-en-Jarez
France CH Bigorre - Site de la Gespe /ID# 218563 Tarbes CEDEX 9 Hautes-Pyrenees
France CHR Metz-Thionville - Hopital Bel-Air /ID# 225691 Thionville
France Hôpital d'Instruction des Armées Sainte-Anne /ID# 218888 Toulon CEDEX 9
France CH Valence /ID# 225877 Valence Drome
Germany Bell, Andernach, DE /ID# 214545 Andernach
Germany Praxis Dr. Mihaescu /ID# 213483 Augsburg
Germany Mauer, Bad Kreuznach, DE /ID# 224876 Bad Kreuznach
Germany Hautmedizin Bad Soden /ID# 213956 Bad Soden am Taunus
Germany Timmel/Timm/Vorwerk, Bergen /ID# 214552 Bergen
Germany Hasert & Hasert, Berlin, DE /ID# 213641 Berlin
Germany Hautarztzentrum Tegel /ID# 214849 Berlin
Germany Hautzentrum Friedrichshain /ID# 213981 Berlin
Germany Praxis Dr. med. Alexander Zich /ID# 245751 Berlin
Germany Weihe/Stavermann, Berlin, DE /ID# 214550 Berlin
Germany Klinikum Rosenhoehe /ID# 215520 Bielefeld
Germany Praxis fuer Innere Medizin/Rheumatologie /ID# 213653 Blaubeuren
Germany Praxis T. Schadeck /ID# 213957 Bogen
Germany Barth, Borna, DE /ID# 213643 Borna
Germany Studienzentrum an der Hase GbR Dr. Weyergraf/Dr. Frick/Thomas Heiber /ID# 214466 Bramsche Niedersachsen
Germany Schwichtenberg, Bremen, DE /ID# 213650 Bremen
Germany Elbe Klinikum Buxtehude /ID# 213366 Buxtehude
Germany Praxis Herbst /ID# 222024 Darmstadt
Germany Praxis Dr. Sbornik /ID# 213668 Deggendorf
Germany Heidlas, Dessau-Rosslau, DE /ID# 217691 Dessau-rosslau
Germany Richter-Huhn, Dresden, DE /ID# 213659 Dresden
Germany Praxis Dr. Korge /ID# 213475 Dueren
Germany Universitaetsklinikum Erlangen /ID# 213669 Erlangen Bayern
Germany Dres. Cesko u. Körber /ID# 214850 Essen
Germany Kurzen, Freising, DE /ID# 214567 Freising
Germany Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 213482 Gelsenkirchen
Germany Praxis Dr. Lange /ID# 213984 Gera
Germany Loth, Gernsbach, DE /ID# 214848 Gernsbach
Germany Gross/Braeu, Giessen, DE /ID# 213367 Giessen
Germany Hautarztpraxis Dr. Viehmann /ID# 213675 Gießen
Germany Brinkmann & Partner, Gladbeck, /ID# 214247 Gladbeck
Germany Dermatologikum Hamburg /ID# 213978 Hamburg
Germany Goldbek Medical /ID# 214570 Hamburg
Germany Universitaetsklinikum Hamburg-Eppendorf /ID# 222464 Hamburg
Germany Praxis Dres. Kaspari /Schenck /ID# 213649 Hannover
Germany Hautarztpraxis Haßberge /ID# 213644 Haßfurt
Germany Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 213113 Heilbad Heiligenstadt
Germany Reinecke, Holzminden, DE /ID# 215081 Holzminden
Germany Universitaetsklinikum Jena /ID# 214259 Jena Thueringen
Germany Derma Sana /ID# 214544 Karlsruhe
Germany DermaKiel Allergie und Haut Centrum /ID# 213977 Kiel Schleswig-Holstein
Germany Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 213670 Kiel Schleswig-Holstein
Germany Grossmann, Koblenz, DE /ID# 214245 Koblenz
Germany Praxis Dres. Bornemann/Reinerth /ID# 213368 Krefeld
Germany Dres. Jacobs & Kollegen /ID# 213652 Kulmbach
Germany Hautarztpraxis Langenau /ID# 213651 Langenau
Germany Neubauer, Leipzig, DE /ID# 214548 Leipzig
Germany Noack-Wiemers, Leipzig, DE /ID# 213654 Leipzig
Germany Hagemeier, Loehne, DE /ID# 214845 Loehne
Germany Dlugosz-Wolf, Luedenscheid, DE /ID# 222000 Luedenscheid
Germany Bruecher, Magdeburg, DE /ID# 213476 Magdeburg
Germany Praxis Dr. Raschke /ID# 225213 Magdeburg
Germany Universitaetsklinikum Magdeburg /ID# 215080 Magdeburg
Germany Dermatologie Quist-BAG Dres. med. Quist PartG /ID# 214249 Mainz
Germany Universitaetsmedizin Mainz /ID# 222025 Mainz Rheinland-Pfalz
Germany Universitatsklinikum Mannheim /ID# 214569 Mannheim Baden-Wuerttemberg
Germany Beldio Research GmbH /ID# 213958 Memmingen Bayern
Germany HMS GmbH Zimmer /ID# 225219 Merzig Saarland
Germany ZENTderma /ID# 213959 Mönchengladbach
Germany Duplicate_Praxis Dres. Kloss/Peterburgskiy /ID# 213960 Neuwied
Germany Zentrum fur Hautgesundheit /ID# 222001 Neuwied
Germany Praxis Dr. Konstantin Ertner /ID# 213640 Nuremberg
Germany Voelkel, Nuremberg, DE /ID# 213671 Nuremberg
Germany Breitsprecher, Osnabrueck, DE /ID# 213672 Osnabrueck
Germany Kramer/Mortazawi, Remscheid /ID# 213477 Remscheid
Germany Praxis Dr. Fränken /ID# 214546 Schwelm
Germany Praxis Dr. Langhoff /ID# 214253 Schwerin
Germany CMS3 Company for Medical Study /ID# 213676 Selters Rheinland-Pfalz
Germany Karl, Soest, DE /ID# 214547 Soest
Germany Praxis Dres. Ziegler & Partner /ID# 213647 Stuttgart
Germany Braun, Ueberlingen, DE /ID# 213646 Ueberlingen
Germany Barnikol, Waltershausen, DE /ID# 213219 Waltershausen
Germany Pfennig, Werdau, DE /ID# 213657 Werdau
Germany Moeller, Wiesbaden, DE /ID# 213955 Wiesbaden
Germany Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 213444 Witten
Germany Franz, Wolfenbuettel, DE /ID# 215355 Wolfenbuettel
Hungary Debreceni Egyetem-Klinikai Kozpont /ID# 212959 Debrecen Hajdu-Bihar
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 212960 Pecs
Hungary Szegedi Tudományegyetem /ID# 212958 Szeged
Hungary Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 212961 Szombathely Vas
Ireland South Infirmary Victoria University Hospital /ID# 213001 Cork
Ireland University Hospital Limerick /ID# 216997 Limerick
Ireland Tallaght University Hospital /ID# 212999 Tallaght Dublin
Italy Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 218558 Bari
Italy ASST Spedali civili di Brescia /ID# 218717 Brescia
Italy Presidio Ospedaliero Gaspare Rodolico /ID# 219032 Catania
Italy Università degli Studi di Firenze /ID# 221383 Florence Firenze
Italy Ospedale Policlinico San Martino /ID# 218844 Genoa Genova
Italy Azienda Ospedaliera Universitaria Mater Domini- Campus Salvatore Venuta /ID# 218902 Germaneto Catanzaro
Italy Presidio Ospedaliero San Salvatore /ID# 218719 L'Aquila L Aquila
Italy IRCCS Istituto Ortopedico Galeazzi /ID# 218867 Milan
Italy IRCCS Policlinico San Donato /ID# 222002 Milan
Italy AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 218546 Napoli
Italy Azienda Ospedaliera Universitaria Federico II /ID# 218808 Napoli
Italy Azienda Ospedaliera di Padova /ID# 221299 Padova
Italy Azienda Ospedaliera di Perugia /ID# 219033 Perugia Umbria
Italy Azienda Ospedaliero Universitaria Pisana /ID# 218555 Pisa
Italy Fondazione PTV Policlinico Tor Vergata /ID# 219031 Rome Roma
Italy Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 218718 Rome Roma
Italy Istituto Clinico Humanitas /ID# 218560 Rozzano Milano
Italy Sapienza University of Rome - Polo Pontino /ID# 218557 Terracina
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 218720 Torette Ancona
Italy Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 218845 Vicenza
Japan Asahikawa Medical University Hospital /ID# 213409 Asahikawa-shi Hokkaido
Japan Nippon Medical School Hospital /ID# 213391 Bunkyo-ku Tokyo
Japan St.Luke's International Hospital /ID# 213392 Chuo-ku Tokyo
Japan Fukuoka University Hospital /ID# 213395 Fukuoka-shi Fukuoka
Japan Kansai Medical University Hospital /ID# 213388 Hirakata-shi Osaka
Japan Imamura General Hospital /ID# 228450 Kagoshima-shi Kagoshima
Japan Kurume University Hospital /ID# 215034 Kurume-shi Fukuoka
Japan Kyoto University Hospital /ID# 213404 Kyoto-shi Kyoto
Japan University Hospital Kyoto Prefectural University of Medicine /ID# 213396 Kyoto-shi Kyoto
Japan Shinshu University Hospital /ID# 213408 Matsumoto-shi Nagano
Japan Matsuyama Red Cross Hospital /ID# 224745 Matsuyama-shi Ehime
Japan The Jikei University Hospital /ID# 213393 Minato-ku Tokyo
Japan Nagoya City University Hospital /ID# 213363 Nagoya shi Aichi
Japan Chukyo Hospital /ID# 213405 Nagoya-shi Aichi
Japan University of the Ryukyus Hospital /ID# 213394 Nakagami-gun Okinawa
Japan Takagi Dermatological Clinic Branch /ID# 213407 Obihiro-shi Hokkaido
Japan Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 224743 Osaka-shi Osaka
Japan JR Sapporo Hospital /ID# 213406 Sapporo-shi Hokkaido
Japan Jichi Medical University Hospital /ID# 213403 Shimotsuke-shi Tochigi
Japan Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 213389 Shinjuku-ku Tokyo
Japan Tokyo Medical University Hospital /ID# 217125 Shinjuku-ku Tokyo
Japan Shizuoka General Hospital /ID# 224744 Shizuoka-shi Shizuoka
Japan Takamatsu Red Cross Hospital /ID# 222875 Takamatsu-shi Kagawa
Japan Takamatsu Red Cross Hospital /ID# 241120 Takamatsu-shi Kagawa
Japan Teikyo University /ID# 213362 Tokyo
Japan Duplicate_Fujita Health University Hospital /ID# 224742 Toyoake-shi Aichi
Japan Mie University Hospital /ID# 213387 Tsu-shi Mie
Mexico Clinica Los Arcos Iztapalapa /Id# 216982 Ciudad de México Ciudad De Mexico
Mexico Consultorio Privado /Id# 225457 Ciudad de México Ciudad De Mexico
Mexico Centro Dermatologico Del Country S de Rl de Cv /Id# 225460 Guadalajara Jalisco
Mexico Grupo Clinico Catei Sociedad Civil /Id# 216978 Guadalajara Jalisco
Mexico Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 216979 Mexico City
Mexico RM Pharma Specialists S.A de C.V. /ID# 225458 Mexico City Ciudad De Mexico
Mexico Dermatologica Sc /Id# 225449 Tijuana Baja California
Mexico Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 216977 Toluca
Netherlands Haaglanden Medisch Centrum /ID# 232063 Den Haag
Netherlands Medisch Centrum Leeuwarden /ID# 215779 Leeuwarden
Netherlands Radboud Universitair Medisch Centrum /ID# 213592 Nijmegen Gelderland
Netherlands Laurentius Ziekenhuis /ID# 230503 Roermond Limburg
Poland COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 225446 Gdansk Pomorskie
Poland Labderm S.C. Beata Bergler-Czop, Barbara Sido-Bergler /Id# 225447 Ozarowice Slaskie
Poland KSW nr1 w Rzeszowie /ID# 225444 Rzeszow Podkarpackie
Poland Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 225415 Warszawa Mazowieckie
Romania Spitalul Clinic Colentina /ID# 214307 Bucuresti
Romania Spitalul Clinic Colentina /ID# 224810 Bucuresti
Romania Spitalul Clinic Colentina /ID# 224811 Bucuresti
Romania Spitalul Clinic Jude?ean de Urgen?e "Sfântul Spiridon" /ID# 214335 Jassi
Saudi Arabia Heraa General Hospital /ID# 217214 Makkah
Saudi Arabia King Abdulaziz Medical City- National Guard Hospital /ID# 224354 Riyadh Ar Riyad
Saudi Arabia King Saud University Med City /ID# 219065 Riyadh
Saudi Arabia Security Forces Hospital /ID# 221073 Riyadh
Spain Hospital Universitario Principe de Asturias /ID# 225085 Alcala de Henares Madrid
Spain Hospital Universitario del Sureste /ID# 226561 Arganda del Rey Madrid
Spain Hospital Universitario de Bajadoz /ID# 225091 Badajoz
Spain Hospital Santa María del Rosell /ID# 225100 Cartagena Murcia
Spain Hospital Universitario de Getafe /ID# 225086 Getafe Madrid
Spain Hospital Universitario Virgen de las Nieves /ID# 225107 Granada
Spain Hospital Juan Ramon Jimenez /ID# 225105 Huelva
Spain Hospital Universitario Severo Ochoa /ID# 225087 Leganes Madrid
Spain Hospital de Leon /ID# 226559 Leon
Spain Hospital Universitario Lucus Augusti /ID# 233282 Lugo
Spain Hospital General Universitario Gregorio Maranon /ID# 231664 Madrid
Spain Hospital Universitario 12 de Octubre /ID# 238474 Madrid
Spain Hospital Universitario Ramon y Cajal /ID# 225093 Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda /ID# 225084 Majadahonda Madrid
Spain Hospital de Manacor /ID# 225083 Manacor Balears
Spain Hospital General de Mostoles /ID# 225088 Mostoles Madrid
Spain Hospital San Telmo /ID# 233283 Palencia
Spain Hospital Universitari Son Espases /ID# 233286 Palma de Mallorca Illes Balears
Spain Hospital Universitario de Puerto Real /ID# 225103 Puerto Real Cadiz
Spain Hospital Universitario de Salamanca /ID# 225078 Salamanca
Spain Hospital Clínico Universitario de Santiago-CHUS /ID# 225076 Santiago de Compostela A Coruna
Spain Hospital Universitario Virgen de Valme /ID# 225104 Sevilla
Spain Hospital Alvaro Cunqueiro CHUVI /ID# 225077 Vigo Pontevedra
Spain Hospital Virgen de la Concha /ID# 233285 Zamora
Spain Hospital Clinico Universitario Lozano Blesa /ID# 231663 Zaragoza
Spain Hospital Royo Villanova /ID# 231665 Zaragoza
Spain Hospital Universitario Miguel Servet /ID# 225080 Zaragoza
Switzerland Universitätsspital Basel /ID# 212744 Basel Town Basel-Stadt
Switzerland Inselspital, Universitaetsspital Bern /ID# 212741 Bern
Switzerland Waldhotel Health & Medical Excellence /Id# 212743 Obburgen Nidwalden
Switzerland Haut. Venen. Allergie. Zentrum Brunnehof /ID# 212742 Uster Zuerich
Switzerland University Hospital Zurich /ID# 216539 Zurich Zuerich
United Arab Emirates Mediclinic Khalifa Branch /ID# 217871 Abu Dhabi
United Arab Emirates New Medical Center Hospital /ID# 223681 Abu Dhabi
United Arab Emirates Skmc /Id# 217873 Abu Dhabi
United Arab Emirates Tawam Hospital /ID# 217872 Abu Dhabi
United Arab Emirates Mediclinic Welcare Hospital /ID# 223683 Dubai
United Kingdom Ulster Hospital - South Eastern Health & Social Care Trust /ID# 215477 Belfast
United Kingdom Cwm Taf Morgannwg University Health Board /ID# 215974 Bridgend Wales
United Kingdom West Suffolk Hospital /ID# 249283 Bury St Edmunds Suffolk
United Kingdom Frimley Health NHS Foundation Trust /ID# 215976 Camberley Surrey
United Kingdom Addenbrooke's Hospital /ID# 215972 Cambridge Cambridgeshire
United Kingdom The Dudley Group NHS Foundation Trust /ID# 215839 Dudley
United Kingdom NHS Lothian /ID# 249287 Edinburgh
United Kingdom The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 215476 Kings Lynn Norfolk
United Kingdom Kingston Hospital NHS Foundation Trust /ID# 215973 Kingston upon Thames Surrey
United Kingdom Kingston Hospital NHS Foundation Trust /ID# 230856 Kingston upon Thames Surrey
United Kingdom Imperial College London - St Mary's Hospital /ID# 215978 London London, City Of
United Kingdom Sandwell and West Birmingham Hospitals NHS Trust /ID# 249294 Lyndon
United Kingdom Northern Care Alliance NHS Group /ID# 218589 Manchester
United Kingdom The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 215479 Newcastle upon Tyne
United Kingdom Northampton General Hospital NHS Trust /ID# 249297 Northampton Northamptonshire
United Kingdom York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 227940 York

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Canada,  Colombia,  Czechia,  France,  Germany,  Hungary,  Ireland,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Romania,  Saudi Arabia,  Spain,  Switzerland,  United Arab Emirates,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90 PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. From Month 4 to 3 years
Primary Time to first treatment change Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening From Week 0 (Baseline) to first treatment change
Secondary Time to first treatment change rate Time to first treatment change including discontinuation, dose escalation and dose interval shortening. At 1 year, 2 year, and 3 year
Secondary Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0 The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. sPGA scores demonstrate overall psoriatic disease with a lower score indicating less body coverage. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the patient's previous disease states, whether at Baseline or at a previous visit. Monthly for up to 3 years
Secondary Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100 PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. Each threshold will be analyzed separately. Monthly for up to 3 years
Secondary Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1 Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately. Monthly for up to 3 years
Secondary Time to achieve sPGA 0/1 or sPGA 0 The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. Up to 3 years
Secondary Time to achieve PASI 75, 90,or 100 PASI 75, 90, or 100 defined as at least a 75%/ 90%/ 100% reduction in PASI relative to Week 0 (Baseline). Each threshold will be analyzed separately. Up to 3 years
Secondary Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval. At 4 months to 1 year, 2 years, and 3 years
Secondary Percentage of participants who achieved PASI 90 or PASI 100 at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval Percentage of participants who achieved PASI 90 or PASI 100 demonstrating a 90 or 100% reduction in PASI at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval. At 4 months and 1 year, 2 years, and 3 years
Secondary Change in PASI PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. From Week 0 to up to 3 years
Secondary Change in Body Surface Area (BSA) BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement. From Week 0 to up to 3 years
Secondary Change in Dermatology Quality of Life Index (DLQI) Score The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much). From Week 0 to up to 3 years
Secondary Percentage of participants who achieve DLQI 0/1 The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. The higher the DLQI score, the more quality of life is impaired. Monthly for up to 3 years
Secondary Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction. From Week 0 to up to 3 years
See also
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