Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis

Chronic Plaque Psoriasis Clinical Trial

— VALUE  

Official title:

Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03982394
• Other study ID #: P19-377
• Status: Active, not recruiting
• Start date: July 1, 2019
• Est. completion date: August 30, 2025

Study information

• Verified date: November 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• 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: August 30, 2025
• Est. primary completion date: August 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.

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

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	Ciuadad Autonoma De Buenos Aires
Argentina	Buenos Aires Skin /ID# 217657	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	CEDIC Centro de Investigaciones Clinicas /ID# 217184	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Instituto de Neumonología y Dermatología /ID# 217429	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Psoriahue Med Interdisciplinar /ID# 217182	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Stat Research /ID# 217185	Ciudad Autonoma de Buenos Aire	Ciuadad 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	Landeskrankenhaus Feldkirch /ID# 216139	Feldkirch	Vorarlberg
Austria	Klinik Landstrasse /ID# 217684	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 216138	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	Lima's Excellence in Allergy and Dermatology Research Inc /ID# 231973	Burlington	Ontario
Canada	Beacon Dermatology Inc /ID# 213524	Calgary	Alberta
Canada	Alberta DermaSurgery Centre /ID# 230114	Edmonton	Alberta
Canada	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	Clinique D /ID# 212126	Laval	Quebec
Canada	Lynderm Research Inc. /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	K. 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
Colombia	Centro Dermatológico Federico Lleras Acosta E.S.E /ID# 222686	Bogotá	Distrito Capital De Bogota
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
Colombia	Fundacion Hospital Universidad del Norte /ID# 223428	Soledad	Atlantico
Colombia	Healthy Medical Center SAS /ID# 231909	Zipaquira	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	Fakultni nemocnice Kralovske Vinohrady /ID# 233184	Praha
Czechia	Fakultni Nemocnice v Motole /ID# 215484	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
France	CHU de CAEN - Hopital de la Cote de Nacre /ID# 216245	Caen
France	Cabinet privé du Dr Bodokh /ID# 229132	Cannes
France	CH William Morey /ID# 225441	Chalon Sur Saone
France	Ch Chalons En Champagne /Id# 216668	Chalons en Champagne
France	Centre Hospitalier de CHAMBERY /ID# 217572	Chambery
France	CHU Dijon /ID# 216247	Dijon	Cote-d Or
France	CHU Grenoble - Hopital Michallon /ID# 218437	La Tronche
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	CH Annecy Genevois Site Annecy /ID# 225786	PRINGY cedex	Haute-Savoie
France	CHU de Rennes - PONTCHAILLOU /ID# 218248	Rennes	Bretagne
France	Hopitaux Drome Nord /ID# 222586	Romans Sur Isere
France	Hôpital d'instruction des armées Bégin /ID# 216167	Saint-Mandé cedex
France	CHU de SAINT ETIENNE - Hopital Nord /ID# 216663	St. Priest En Jarez	Loire
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	Studiengesellschaft an der Hase GbR Praxis Weyergraf/Frick/Heiber /ID# 214466	Bramsche
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 GmbH /ID# 213978	Hamburg
Germany	Goldbek Medical /ID# 214570	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf (UKE) /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	Praxis Dr. Schwarz /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. Quist PartG /ID# 214249	Mainz
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222025	Mainz
Germany	Universitatsklinikum Mannheim /ID# 214569	Mannheim	Baden-Wuerttemberg
Germany	Beldio Research GmbH /ID# 213958	Memmingen
Germany	HMS GmbH Zimmer /ID# 225219	Merzig
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 Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 212958	Szeged	Csongrad
Hungary	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 Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 218720	Ancona
Italy	Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 218558	Bari
Italy	ASST Spedali civili di Brescia /ID# 218717	Brescia
Italy	A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219032	Catania
Italy	Università degli Studi di Firenze /ID# 221383	Florence
Italy	Ospedale Policlinico San Martino /ID# 218844	Genova
Italy	Azienda Ospedaliera Universitaria Mater Domini- Campus Salvatore Venuta /ID# 218902	Germaneto	Catanzaro
Italy	Presidio Ospedaliero San Salvatore /ID# 218719	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-Stabilimento di Santa Chiara /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	Ospedale Fiorini di Terracina /ID# 218557	Terracina
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	Teikyo University Hospital /ID# 213362	Itabashi-ku	Tokyo
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 Dermatology Clinic /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	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
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	Centralny Szpital Kliniczny 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 Judetean de Urgenta Sf. Spiridon Iasi /Id# 214335	Iasi
Saudi Arabia	Heraa General Hospital /ID# 217214	Makkah
Saudi Arabia	King Saud University Med City /ID# 219065	Riyadh
Saudi Arabia	KKing Abdulaziz Medical City- National Guard Hospital /ID# 224354	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, Region De
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	Basel-Stadt
Switzerland	Inselspital, Universitätsspital Bern /ID# 212741	Bern
Switzerland	Waldhotel Health & Medical Excellence /Id# 212743	Obburgen	Nidwalden
Switzerland	Kantonsspital St. Gallen /ID# 215488	St. Gallen	Sankt Gallen
Switzerland	Haut. Venen. Allergie. Zentrum Brunnehof /ID# 212742	Uster	Zuerich
Switzerland	Universitatsspital 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	South Eastern Health and Social Care Trust /ID# 215477	Belfast	Antrim
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
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 215972	Cambridge
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	England
United Kingdom	Kingston Hospital NHS Foundation Trust /ID# 230856	Kingston upon Thames	England
United Kingdom	Imperial College Healthcare NHS Trust /ID# 215978	London
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 /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

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