Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis (VALUE)

November 10, 2023 updated by: AbbVie

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

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.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Estimated)

2439

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, 1024
        • Professional Skin Care /ID# 218514
      • Caba, Argentina, C1199ABB
        • Hospital Italiano /ID# 217000
      • Ciudad Autonoma Buenos Aires, Argentina, 1425
        • Private Office Cristina Echeverria /ID# 222082
    • Buenos Aires
      • Lomas de Zamora, Buenos Aires, Argentina, 1832
        • Emiliano Baccarini Priv Practice /ID# 218581
      • Pilar, Buenos Aires, Argentina, 1629
        • Hospital Universitario Austral /ID# 217540
    • Ciuadad Autonoma De Buenos Aires
      • Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1114
        • Stringa Dermatologia /ID# 218450
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1023
        • Stat Research /ID# 217185
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1055
        • Buenos Aires Skin /ID# 217657
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1425
        • CEDIC Centro de Investigaciones Clinicas /ID# 217184
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1425
        • Instituto de Neumonología y Dermatología /ID# 217429
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1425
        • Psoriahue Med Interdisciplinar /ID# 217182
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Premier Specialist /ID# 218158
      • Miranda, New South Wales, Australia, 2228
        • Kingsway Dermatology & Aesthetics /ID# 217616
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Northern Dermatology /ID# 218374
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research /ID# 217618
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin Health Institute Inc /ID# 217619
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology /ID# 217617
    • Oberoesterreich
      • Wels, Oberoesterreich, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH /ID# 216140
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6800
        • Landeskrankenhaus Feldkirch /ID# 216139
    • Wien
      • Vienna, Wien, Austria, 1030
        • Klinik Landstrasse /ID# 217684
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitaet Wien /ID# 216138
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Beacon Dermatology Inc /ID# 213524
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical /ID# 213526
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta DermaSurgery Centre /ID# 230114
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 213507
    • Manitoba
      • Brandon, Manitoba, Canada, R7A 0L5
        • SKIN Clinics /ID# 213082
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Winnipeg Clinic /ID# 212134
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Dr. Irina Turchin PC Inc. /ID# 212128
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
        • Karma Clinical Trials /ID# 213522
      • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
        • NewLab Clinical Research Inc. /ID# 213521
      • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
        • Dr. Brown-Maher PMC INC. /ID# 212136
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • CCA Medical Research /ID# 214446
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Center /ID# 213081
      • Burlington, Ontario, Canada, L7R 4H9
        • Lima's Excellence in Allergy and Dermatology Research Inc /ID# 231973
      • Hamilton, Ontario, Canada, L8L 3C3
        • LEADER Research /ID# 249701
      • Hamilton, Ontario, Canada, L8L 8E7
        • Hamilton Health Sciences Corporation /ID# 214053
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research /ID# 213523
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc. /ID# 212124
      • Mississauga, Ontario, Canada, L4W 0C2
        • Al-Mohammedi Medicine Professional Corporation /ID# 215408
      • Mississauga, Ontario, Canada, L5H 1G9
        • DermEdge Research Inc. /ID# 213525
      • Ottawa, Ontario, Canada, K1H 7X3
        • Angela Montgomery Medicine Professional Corporation /ID# 213615
      • Peterborough, Ontario, Canada, K9J 5K2
        • Dr Melinda Gooderham Medicine Professional Corporation /ID# 212133
      • Stoney Creek, Ontario, Canada, L8G 1H1
        • Farheen Mussani Medicine Professional Corporation /ID# 213811
      • Toronto, Ontario, Canada, M2N 3A6
        • North York Research Inc /ID# 213486
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research /ID# 212130
      • Whitby, Ontario, Canada, L1N 8M7
        • Dr Maksym Breslavets Medicine Professional Corporation /ID# 213338
    • Quebec
      • Laval, Quebec, Canada, H7N 6L2
        • Clinique D /ID# 212126
      • Quebec City, Quebec, Canada, G1W 4R4
        • Centre de Recherche St-Louis /ID# 216325
      • Barranqulla, Colombia, 080016
        • Ciensalud IPS S.A.S /ID# 244608
      • Bogotá, Colombia, 110221
        • Caja de Compensación Familiar Cafam, Sede Centro de Atención En Salud Cafam Flor /ID# 222660
      • Medellín, Colombia, 050010
        • Fundacion hospitalaria San Vicente de Paul /ID# 222680
    • Antioquia
      • Medellin, Antioquia, Colombia, 055422
        • Clinisalud del sur /ID# 222685
      • Medellin, Antioquia, Colombia, 50010
        • IPS Universitaria /ID# 241832
    • Atlantico
      • Soledad, Atlantico, Colombia, 83001
        • Fundacion Hospital Universidad del Norte /ID# 223428
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111711
        • Sociedad de Cirugía de Bogotá- Hospital de San José /ID# 222683
      • Zipaquira, Cundinamarca, Colombia, 250252
        • Healthy Medical Center SAS /ID# 231909
    • Distrito Capital De Bogota
      • Bogotá, Distrito Capital De Bogota, Colombia, 111511
        • Centro Dermatológico Federico Lleras Acosta E.S.E /ID# 222686
      • Ceske Budejovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s. /ID# 216310
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove /ID# 222670
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc /ID# 215901
      • Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady /ID# 233184
      • Praha, Czechia, 110 00
        • Sanatorium profesora Arenbergera /ID# 215489
      • Praha, Czechia, 150 06
        • Fakultni Nemocnice v Motole /ID# 215484
      • Aix En Provence Cedex 1, France, 13616
        • CH du Pays d'AIX /ID# 216440
      • Angers, France, 49933
        • Chu Angers /Id# 216244
      • Boulogne Billancourt, France, 92104
        • Hopital Ambroise Pare /ID# 216439
      • Brest, France, 29200
        • Hopital de la Cavale Blanche /ID# 216495
      • Caen, France, 14033
        • CHU de CAEN - Hopital de la Cote de Nacre /ID# 216245
      • Cannes, France, 06400
        • Cabinet privé du Dr Bodokh /ID# 229132
      • Chalon Sur Saone, France, 71321
        • CH William Morey /ID# 225441
      • Chalons en Champagne, France, 51000
        • Ch Chalons En Champagne /Id# 216668
      • Chambery, France, 73000
        • Centre Hospitalier de CHAMBERY /ID# 217572
      • La Tronche, France, 38700
        • CHU Grenoble - Hopital Michallon /ID# 218437
      • Lorient, France, 56322
        • C.H. de Bretagne Sud /ID# 216243
      • Romans Sur Isere, France, 26100
        • Hopitaux Drome Nord /ID# 222586
      • Saint-Mandé cedex, France, 94163
        • Hôpital d'instruction des armées Bégin /ID# 216167
      • Thionville, France, 57100
        • CHR Metz-Thionville - Hopital Bel-Air /ID# 225691
      • Toulon CEDEX 9, France, 83800
        • Hôpital d'Instruction des Armées Sainte-Anne /ID# 218888
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13008
        • Hopital Saint Joseph /ID# 223149
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • CHU de Rennes - PONTCHAILLOU /ID# 218248
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21000
        • CHU Dijon /ID# 216247
    • Deux-Sevres
      • Niort CEDEX, Deux-Sevres, France, 79028
        • CH Georges Renon /ID# 216174
    • Drome
      • Valence, Drome, France, 26000
        • CH Valence /ID# 225877
    • Haute-Savoie
      • PRINGY cedex, Haute-Savoie, France, 74374
        • CH Annecy Genevois Site Annecy /ID# 225786
    • Hautes-Pyrenees
      • Tarbes CEDEX 9, Hautes-Pyrenees, France, 65013
        • CH Bigorre - Site de la Gespe /ID# 218563
    • Loire
      • St. Priest En Jarez, Loire, France, 42270
        • CHU de SAINT ETIENNE - Hopital Nord /ID# 216663
    • Sarthe
      • Le Mans CEDEX 9, Sarthe, France, 72037
        • Centre Hospitalier du Mans /ID# 225729
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 216170
    • Val-d Oise
      • Pontoise, Val-d Oise, France, 95300
        • CH Pontoise - Hopital René Dubos /ID# 216169
    • Yonne
      • Auxerre, Yonne, France, 89011
        • Ch Auxerre /Id# 216175
      • Andernach, Germany, 56626
        • Bell, Andernach, DE /ID# 214545
      • Augsburg, Germany, 86150
        • Praxis Dr. Mihaescu /ID# 213483
      • Bad Kreuznach, Germany, 55543
        • Mauer, Bad Kreuznach, DE /ID# 224876
      • Bad Soden am Taunus, Germany, 65812
        • Hautmedizin Bad Soden /ID# 213956
      • Bergen, Germany, 18528
        • Timmel/Timm/Vorwerk, Bergen /ID# 214552
      • Berlin, Germany, 10117
        • Hasert & Hasert, Berlin, DE /ID# 213641
      • Berlin, Germany, 10247
        • Hautzentrum Friedrichshain /ID# 213981
      • Berlin, Germany, 12353
        • Weihe/Stavermann, Berlin, DE /ID# 214550
      • Berlin, Germany, 12681
        • Praxis Dr. med. Alexander Zich /ID# 245751
      • Berlin, Germany, 13507
        • Hautarztzentrum Tegel /ID# 214849
      • Bielefeld, Germany, 33647
        • Klinikum Rosenhoehe /ID# 215520
      • Blaubeuren, Germany, 89143
        • Praxis fuer Innere Medizin/Rheumatologie /ID# 213653
      • Bogen, Germany, 94327
        • Praxis T. Schadeck /ID# 213957
      • Borna, Germany, 04552
        • Barth, Borna, DE /ID# 213643
      • Bramsche, Germany, 49565
        • Studiengesellschaft an der Hase GbR Praxis Weyergraf/Frick/Heiber /ID# 214466
      • Bremen, Germany, 28779
        • Schwichtenberg, Bremen, DE /ID# 213650
      • Buxtehude, Germany, 21614
        • Elbe Klinikum Buxtehude /ID# 213366
      • Darmstadt, Germany, 64283
        • Praxis Herbst /ID# 222024
      • Deggendorf, Germany, 94469
        • Praxis Dr. Sbornik /ID# 213668
      • Dessau-rosslau, Germany, 06842
        • Heidlas, Dessau-Rosslau, DE /ID# 217691
      • Dresden, Germany, 01219
        • Richter-Huhn, Dresden, DE /ID# 213659
      • Dueren, Germany, 52349
        • Praxis Dr. Korge /ID# 213475
      • Essen, Germany, 45130
        • Dres. Cesko u. Körber /ID# 214850
      • Freising, Germany, 85354
        • Kurzen, Freising, DE /ID# 214567
      • Gelsenkirchen, Germany, 45899
        • Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 213482
      • Gera, Germany, 07548
        • Praxis Dr. Lange /ID# 213984
      • Gernsbach, Germany, 76593
        • Loth, Gernsbach, DE /ID# 214848
      • Giessen, Germany, 35390
        • Gross/Braeu, Giessen, DE /ID# 213367
      • Gießen, Germany, 35390
        • Hautarztpraxis Dr. Viehmann /ID# 213675
      • Gladbeck, Germany, 45964
        • Brinkmann & Partner, Gladbeck, /ID# 214247
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 222464
      • Hamburg, Germany, 20354
        • Dermatologikum Hamburg GmbH /ID# 213978
      • Hamburg, Germany, 22303
        • Goldbek Medical /ID# 214570
      • Hannover, Germany, 30159
        • Praxis Dres. Kaspari /Schenck /ID# 213649
      • Haßfurt, Germany, 97437
        • Hautarztpraxis Haßberge /ID# 213644
      • Heilbad Heiligenstadt, Germany, 37308
        • Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 213113
      • Holzminden, Germany, 37603
        • Reinecke, Holzminden, DE /ID# 215081
      • Karlsruhe, Germany, 76133
        • Derma Sana /ID# 214544
      • Koblenz, Germany, 56068
        • Grossmann, Koblenz, DE /ID# 214245
      • Krefeld, Germany, 47798
        • Praxis Dres. Bornemann/Reinerth /ID# 213368
      • Kulmbach, Germany, 95326
        • Dres. Jacobs & Kollegen /ID# 213652
      • Langenau, Germany, 89129
        • Praxis Dr. Schwarz /ID# 213651
      • Leipzig, Germany, 04209
        • Neubauer, Leipzig, DE /ID# 214548
      • Leipzig, Germany, 04289
        • Noack-Wiemers, Leipzig, DE /ID# 213654
      • Loehne, Germany, 32584
        • Hagemeier, Loehne, DE /ID# 214845
      • Luedenscheid, Germany, 58507
        • Dlugosz-Wolf, Luedenscheid, DE /ID# 222000
      • Magdeburg, Germany, 39104
        • Bruecher, Magdeburg, DE /ID# 213476
      • Magdeburg, Germany, 39104
        • Praxis Dr. Raschke /ID# 225213
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg /ID# 215080
      • Mainz, Germany, 55128
        • Dermatologie Quist - BAG Dres. Quist PartG /ID# 214249
      • Mainz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222025
      • Memmingen, Germany, 87700
        • Beldio Research GmbH /ID# 213958
      • Merzig, Germany, 66663
        • HMS GmbH Zimmer /ID# 225219
      • Mönchengladbach, Germany, 41061
        • ZENTderma /ID# 213959
      • Neuwied, Germany, 56564
        • Duplicate_Praxis Dres. Kloss/Peterburgskiy /ID# 213960
      • Neuwied, Germany, 56564
        • Zentrum fur Hautgesundheit /ID# 222001
      • Nuremberg, Germany, 90402
        • Praxis Dr. Konstantin Ertner /ID# 213640
      • Nuremberg, Germany, 90419
        • Voelkel, Nuremberg, DE /ID# 213671
      • Osnabrueck, Germany, 49074
        • Breitsprecher, Osnabrueck, DE /ID# 213672
      • Remscheid, Germany, 42897
        • Kramer/Mortazawi, Remscheid /ID# 213477
      • Schwelm, Germany, 58332
        • Praxis Dr. Fränken /ID# 214546
      • Schwerin, Germany, 19053
        • Praxis Dr. Langhoff /ID# 214253
      • Soest, Germany, 59494
        • Karl, Soest, DE /ID# 214547
      • Stuttgart, Germany, 70190
        • Praxis Dres. Ziegler & Partner /ID# 213647
      • Ueberlingen, Germany, 88662
        • Braun, Ueberlingen, DE /ID# 213646
      • Waltershausen, Germany, 99880
        • Barnikol, Waltershausen, DE /ID# 213219
      • Werdau, Germany, 08412
        • Pfennig, Werdau, DE /ID# 213657
      • Wiesbaden, Germany, 65185
        • Moeller, Wiesbaden, DE /ID# 213955
      • Witten, Germany, 58453
        • Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 213444
      • Wolfenbuettel, Germany, 38300
        • Franz, Wolfenbuettel, DE /ID# 215355
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Universitatsklinikum Mannheim /ID# 214569
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitaetsklinikum Erlangen /ID# 213669
    • Rheinland-Pfalz
      • Selters, Rheinland-Pfalz, Germany, 56242
        • CMS3 Company for Medical Study /ID# 213676
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 213670
      • Kiel, Schleswig-Holstein, Germany, 24148
        • DermaKiel Allergie und Haut Centrum /ID# 213977
    • Thueringen
      • Jena, Thueringen, Germany, 07747
        • Universitaetsklinikum Jena /ID# 214259
      • Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 212960
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 212958
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 212959
    • Vas
      • Szombathely, Vas, Hungary, 9700
        • Markusovszky Egyetemi Oktatokorhaz /ID# 212961
      • Cork, Ireland, T12 X23H
        • South Infirmary Victoria University Hospital /ID# 213001
      • Limerick, Ireland, V94 F858
        • University Hospital Limerick /ID# 216997
    • Dublin
      • Tallaght, Dublin, Ireland, D24 NR0A
        • Tallaght University Hospital /ID# 212999
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 218720
      • Bari, Italy, 70124
        • Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 218558
      • Brescia, Italy, 25123
        • ASST Spedali civili di Brescia /ID# 218717
      • Catania, Italy, 95123
        • A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219032
      • Florence, Italy, 50122
        • Università degli Studi di Firenze /ID# 221383
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino /ID# 218844
      • L'Aquila, Italy, 67100
        • Presidio Ospedaliero San Salvatore /ID# 218719
      • Milan, Italy, 20097
        • IRCCS Policlinico San Donato /ID# 222002
      • Milan, Italy, 20161
        • IRCCS Istituto Ortopedico Galeazzi /ID# 218867
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II /ID# 218808
      • Napoli, Italy, 80138
        • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 218546
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova /ID# 221299
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 218555
      • Terracina, Italy, 04019
        • Ospedale Fiorini di Terracina /ID# 218557
      • Vicenza, Italy, 36100
        • Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 218845
    • Catanzaro
      • Germaneto, Catanzaro, Italy, 88100
        • Azienda Ospedaliera Universitaria Mater Domini- Campus Salvatore Venuta /ID# 218902
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas /ID# 218560
    • Roma
      • Rome, Roma, Italy, 00133
        • Fondazione PTV Policlinico Tor Vergata /ID# 219031
      • Rome, Roma, Italy, 00168
        • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 218718
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Azienda Ospedaliera di Perugia /ID# 219033
    • Aichi
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 213363
      • Nagoya-shi, Aichi, Japan, 457-8510
        • Chukyo Hospital /ID# 213405
      • Toyoake-shi, Aichi, Japan, 470-1192
        • Fujita Health University Hospital /ID# 224742
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital /ID# 224745
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 213395
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 215034
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 213409
      • Obihiro-shi, Hokkaido, Japan, 080-0013
        • Takagi Dermatology Clinic /ID# 213407
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • JR Sapporo Hospital /ID# 213406
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-0017
        • Takamatsu Red Cross Hospital /ID# 222875
      • Takamatsu-shi, Kagawa, Japan, 760-0017
        • Takamatsu Red Cross Hospital /ID# 241120
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-0064
        • Imamura General Hospital /ID# 228450
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID# 213396
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 213404
    • Mie
      • Tsu-shi, Mie, Japan, 514-8507
        • Mie University Hospital /ID# 213387
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Shinshu University Hospital /ID# 213408
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • University of the Ryukyus Hospital /ID# 213394
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital /ID# 213388
      • Osaka-shi, Osaka, Japan, 550-0006
        • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 224743
    • Shizuoka
      • Shizuoka-shi, Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital /ID# 224744
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital /ID# 213403
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8602
        • Nippon Medical School Hospital /ID# 213391
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St.Luke's International Hospital /ID# 213392
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Teikyo University Hospital /ID# 213362
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 213393
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital /ID# 217125
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 213389
      • Mexico City, Mexico, 11650
        • Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 216979
      • Toluca, Mexico, 50120
        • Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 216977
    • Baja California
      • Tijuana, Baja California, Mexico, 22010
        • Dermatologica Sc /Id# 225449
    • Ciudad De Mexico
      • Ciudad de México, Ciudad De Mexico, Mexico, 06500
        • Consultorio Privado /Id# 225457
      • Ciudad de México, Ciudad De Mexico, Mexico, 09260
        • Clinica Los Arcos Iztapalapa /Id# 216982
      • Mexico City, Ciudad De Mexico, Mexico, 03100
        • RM Pharma Specialists S.A de C.V. /ID# 225458
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44610
        • Centro Dermatologico Del Country S de Rl de Cv /Id# 225460
      • Guadalajara, Jalisco, Mexico, 44657
        • Grupo Clinico Catei Sociedad Civil /Id# 216978
      • Den Haag, Netherlands, 2512 VA
        • Haaglanden Medisch Centrum /ID# 232063
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 215779
      • Roermond, Netherlands, 6043 CV
        • Laurentius Ziekenhuis /ID# 230503
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum /ID# 213592
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 225415
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-055
        • KSW nr1 w Rzeszowie /ID# 225444
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-462
        • COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 225446
    • Slaskie
      • Ozarowice, Slaskie, Poland, 42-624
        • Labderm S.C. Beata Bergler-Czop, Barbara Sido-Bergler /Id# 225447
      • Bucuresti, Romania, 020121
        • Spitalul Clinic Colentina /ID# 214307
      • Bucuresti, Romania, 020121
        • Spitalul Clinic Colentina /ID# 224810
      • Bucuresti, Romania, 020121
        • Spitalul Clinic Colentina /ID# 224811
      • Iasi, Romania, 700098
        • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi /Id# 214335
      • Makkah, Saudi Arabia
        • Heraa General Hospital /ID# 217214
      • Riyadh, Saudi Arabia, 11495
        • KKing Abdulaziz Medical City- National Guard Hospital /ID# 224354
      • Riyadh, Saudi Arabia, 12372
        • King Saud University Med City /ID# 219065
      • Riyadh, Saudi Arabia, 12625
        • Security Forces Hospital /ID# 221073
      • Badajoz, Spain, 06080
        • Hospital Universitario de Bajadoz /ID# 225091
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves /ID# 225107
      • Huelva, Spain, 21005
        • Hospital Juan Ramon Jimenez /ID# 225105
      • Leon, Spain, 24071
        • Hospital de Leon /ID# 226559
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti /ID# 233282
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 231664
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 225093
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 238474
      • Palencia, Spain, 34004
        • Hospital San Telmo /ID# 233283
      • Salamanca, Spain, 37711
        • Hospital Universitario de Salamanca /ID# 225078
      • Sevilla, Spain, 41014
        • Hospital Universitario Virgen de Valme /ID# 225104
      • Zamora, Spain, 49022
        • Hospital Virgen de la Concha /ID# 233285
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa /ID# 231663
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet /ID# 225080
      • Zaragoza, Spain, 50015
        • Hospital Royo Villanova /ID# 231665
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Hospital Clínico Universitario de Santiago-CHUS /ID# 225076
    • Balears
      • Manacor, Balears, Spain, 07500
        • Hospital de Manacor /ID# 225083
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Hospital Universitario de Puerto Real /ID# 225103
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07120
        • Hospital Universitari Son Espases /ID# 233286
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Hospital Universitario Principe de Asturias /ID# 225085
      • Arganda del Rey, Madrid, Spain, 28500
        • Hospital Universitario del Sureste /ID# 226561
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario de Getafe /ID# 225086
      • Leganes, Madrid, Spain, 28911
        • Hospital Universitario Severo Ochoa /ID# 225087
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 225084
      • Mostoles, Madrid, Spain, 28935
        • Hospital General de Mostoles /ID# 225088
    • Murcia, Region De
      • Cartagena, Murcia, Region De, Spain, 30203
        • Hospital Santa María del Rosell /ID# 225100
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Hospital Alvaro Cunqueiro CHUVI /ID# 225077
      • Bern, Switzerland, 3010
        • Inselspital, Universitätsspital Bern /ID# 212741
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Universitätsspital Basel /ID# 212744
    • Nidwalden
      • Obburgen, Nidwalden, Switzerland, 6363
        • Waldhotel Health & Medical Excellence /Id# 212743
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 215488
    • Zuerich
      • Uster, Zuerich, Switzerland, 8610
        • Haut. Venen. Allergie. Zentrum Brunnehof /ID# 212742
      • Zurich, Zuerich, Switzerland, 8091
        • Universitatsspital Zurich /ID# 216539
      • Abu Dhabi, 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
      • Dubai, United Arab Emirates
        • Mediclinic Welcare Hospital /ID# 223683
      • Camberley, United Kingdom, GU16 7UJ
        • Frimley Health NHS Foundation Trust /ID# 215976
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust /ID# 215972
      • Dudley, United Kingdom, DY1 2HQ
        • The Dudley Group NHS Foundation Trust /ID# 215839
      • Edinburgh, United Kingdom, EH3 9HE
        • NHS Lothian /ID# 249287
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust /ID# 215978
      • Lyndon, United Kingdom, B71 4HJ
        • Sandwell and West Birmingham Hospitals NHS Trust /ID# 249294
      • Manchester, United Kingdom, M8 5RB
        • Northern Care Alliance NHS Group /ID# 218589
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 215479
      • York, United Kingdom, YO31 8HE
        • York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 227940
    • Antrim
      • Belfast, Antrim, United Kingdom, BT16 1RH
        • South Eastern Health and Social Care Trust /ID# 215477
    • England
      • Kingston upon Thames, England, United Kingdom, KT2 7QB
        • Kingston Hospital NHS Foundation Trust /ID# 215973
      • Kingston upon Thames, England, United Kingdom, KT2 7QB
        • Kingston Hospital NHS Foundation Trust /ID# 230856
    • Norfolk
      • Kings Lynn, Norfolk, United Kingdom, PE30 4ET
        • The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 215476
    • Northamptonshire
      • Northampton, Northamptonshire, United Kingdom, NN1 5BD
        • Northampton General Hospital /ID# 249297
    • Suffolk
      • Bury St Edmunds, Suffolk, United Kingdom, IP33 2QZ
        • West Suffolk Hospital /ID# 249283
    • Wales
      • Bridgend, Wales, United Kingdom, CF31 1RQ
        • Cwm Taf Morgannwg University Health Board /ID# 215974

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll adult subjects with moderate to severe plaque psoriasis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants treated with Risankizumab
Treatment decision independently made of study enrollment
Participants treated with other approved biological therapies
Treatment decision independently made of study enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90
Time Frame: From Month 4 to 3 years
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
Time to first treatment change
Time Frame: From Week 0 (Baseline) 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first treatment change rate
Time Frame: At 1 year, 2 year, and 3 year
Time to first treatment change including discontinuation, dose escalation and dose interval shortening.
At 1 year, 2 year, and 3 year
Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0
Time Frame: Monthly for up to 3 years
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
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100
Time Frame: Monthly for up to 3 years
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
Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1
Time Frame: Monthly for up to 3 years
Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately.
Monthly for up to 3 years
Time to achieve sPGA 0/1 or sPGA 0
Time Frame: Up to 3 years
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
Time to achieve PASI 75, 90,or 100
Time Frame: Up to 3 years
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
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
Time Frame: At 4 months to 1 year, 2 years, and 3 years
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
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
Time Frame: At 4 months and 1 year, 2 years, and 3 years
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
Change in PASI
Time Frame: From Week 0 to up to 3 years
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
Change in Body Surface Area (BSA)
Time Frame: From Week 0 to up to 3 years
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
Change in Dermatology Quality of Life Index (DLQI) Score
Time Frame: From Week 0 to up to 3 years
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
Percentage of participants who achieve DLQI 0/1
Time Frame: Monthly for up to 3 years
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
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score
Time Frame: From Week 0 to up to 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Plaque Psoriasis

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