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An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
Sponsor: AbbVie
Summary
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
Official title: A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1019
Start Date
2023-06-09
Completion Date
2028-07
Last Updated
2025-05-09
Healthy Volunteers
No
Conditions
Locations (154)
Universitaetsklinikum St. Poelten /ID# 258828
Sankt Pölten, Lower Austria, Austria
Medizinische Universitaet Graz /ID# 253559
Graz, Styria, Austria
Medizinische Universitaet Innsbruck /ID# 253563
Innsbruck, Tyrol, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 253558
Wels, Upper Austria, Austria
Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824
Vienna, Vienna, Austria
Medizinische Universitaet Wien /ID# 261472
Vienna, Vienna, Austria
University of Calgary /ID# 254511
Calgary, Alberta, Canada
Gastroenterology and Internal Medicine Research Institution /ID# 253319
Edmonton, Alberta, Canada
South Edmonton Gastroenterology Research Clinic /ID# 253160
Edmonton, Alberta, Canada
Six08 Gastroenterology /ID# 254513
Lethbridge, Alberta, Canada
Dr. Sundeep Singh, Inc /ID# 254250
Kelowna, British Columbia, Canada
Fraser Clinical Trials Inc /ID# 254512
New Westminster, British Columbia, Canada
Percuro Clinical Research, Ltd /ID# 256339
Victoria, British Columbia, Canada
The Moncton Hospital /ID# 252960
Moncton, New Brunswick, Canada
Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661
Hamilton, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 252961
North Bay, Ontario, Canada
Physician's Clinical Research Inc. /ID# 256494
North York, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc /ID# 253946
North York, Ontario, Canada
Taunton surgical centre /ID# 253812
Oshawa, Ontario, Canada
Toronto Digestive Disease Associates /ID# 253813
Vaughan, Ontario, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522
Montreal, Quebec, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 254626
Montreal, Quebec, Canada
Diex Recherche Québec /ID# 254016
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS /ID# 254591
Sherbrooke, Quebec, Canada
Hôpital l'Archet /ID# 253097
Nice, Alpes-Maritimes, France
APHM - Hopital Nord /ID# 253364
Marseille, Bouches-du-Rhone, France
CHU de Besancon - Jean Minjoz /ID# 253098
Besançon, Doubs, France
Hopital de la Cavale Blanche /ID# 253100
Brest, Finistere, France
Centre Hospitalier de Quimper /ID# 254052
Quimper, Finistere, France
CHU NIMES - Hopital Caremeau /ID# 254060
Nîmes, Gard, France
Centre Hospitalier Universitaire de Bordeaux /ID# 253095
Pessac, Gironde, France
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 253088
Colmar, Grand Est, France
CHU Toulouse - Hopital Rangueil /ID# 253094
Toulouse, Haute-Garonne, France
CHU Montpellier - Hopital Saint Eloi /ID# 253096
Montpellier, Herault, France
CHU Reims - Hôpital Robert Debre /ID# 253366
Reims, Marne, France
Centre Hospitalier de Dunkerque /ID# 253837
Dunkirk, Nord, France
CHRU Lille - Hopital Claude Huriez /ID# 253099
Lille, Nord, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 253091
Créteil, Paris, France
AP-HP - Hopital Bicetre /ID# 253093
Le Kremlin-Bicêtre, Paris, France
CHU de Nantes, Hotel Dieu -HME /ID# 254047
Nantes, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 253102
St-Priest-en-Jarez, Pays de la Loire Region, France
HCL - Hopital de la Croix-Rousse /ID# 256413
Lyon, Rhone, France
HCL - Hopital Lyon Sud /ID# 253104
Pierre-Bénite, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 253089
Amiens, Somme, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 253368
Caen, France
CHRU Tours - Hopital Trousseau /ID# 253369
Chambray-lès-Tours, France
Clinique de Bercy /Id# 253139
Charenton-le-Pont, France
CH Annecy Genevois - Site Annecy /ID# 253103
Epagny Metz Tessy, France
CH Haguenau /ID# 253109
Haguenau, France
Clinique Jules Verne /ID# 253939
Nantes, France
AP-HP - Hopital Saint-Antoine /ID# 254044
Paris, France
CHU de Rouen /ID# 253107
Rouen, France
Centre Hospitalier Tarbes-Lourdes /ID# 253943
Tarbes, France
Hôpital Schuman /ID# 254781
Vantoux, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 253358
Neuilly-sur-Seine, Île-de-France Region, France
Universitaetsklinikum Heidelberg /ID# 272329
Heidelberg, Baden-Wurttemberg, Germany
Praxis fuer Gastroenterologie /ID# 260994
Heidelberg, Baden-Wurttemberg, Germany
Medizinisches Versorgunszentrum Dachau /ID# 262592
Dachau, Bavaria, Germany
Universitaetsklinikum Erlangen /ID# 269946
Erlangen, Bavaria, Germany
Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 262895
Kassel, Hesse, Germany
Gastroenterologische Schwerpunktpraxis /ID# 275444
Hanover, Lower Saxony, Germany
Mueller/Mueller-Ziehm, Hanover /ID# 261599
Hanover, Lower Saxony, Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 261148
Minden, North Rhine-Westphalia, Germany
Magen-Darm-Zentrum-Remscheid /ID# 260681
Remscheid, North Rhine-Westphalia, Germany
Klinikum Worms gGmbH /ID# 269803
Worms, Rhineland-Palatinate, Germany
Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 261361
Friedrichsthal, Saarland, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 257602
Saarbrücken, Saarland, Germany
Praxisgemeinschaft Jerichow Schulze /ID# 262036
Jerichow, Saxony-Anhalt, Germany
Praxis Jessen/Grimm /ID# 257610
Altenholz, Schleswig-Holstein, Germany
Praxis S. Tetzlaff /ID# 257608
Buedelsdorf, Schleswig-Holstein, Germany
Praxis fuer Gastroenterologie /ID# 257607
Lübeck, Schleswig-Holstein, Germany
Praxis Heil & Mueller /ID# 265211
Andernach, Germany
Praxis Dr. Schiffelholz /ID# 265218
Augsburg, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 262462
Berlin, Germany
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 260995
Berlin, Germany
Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262711
Berlin, Germany
Krankenhaus Waldfriede /ID# 262341
Berlin-Zehlendorf, Germany
Dr. Janschek /ID# 260993
Dresden, Germany
Dres. Ende / Weisflog /ID# 262038
Erfurt, Germany
Dres. Bauer/Doerflinger /ID# 262531
Freiburg im Breisgau, Germany
Dres. Behrens/Fechner/Streudel /ID# 257601
Halle, Germany
Städtisches Kh. Heinsberg GmbH /ID# 258671
Heinsberg, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 261122
Herne, Germany
MVZ Dres. Al-Kadi & Partner /ID# 260996
Iserlohn, Germany
Dres. Breitschwerdt/Glas/Gurtler /ID# 257612
Leipzig, Germany
Gastropraxis Magdeburg /ID# 261340
Magdeburg, Germany
Gastro.Praxis am Meerbachbogen /ID# 265900
Nienburg, Germany
Dres. Hundorfean/Tex /ID# 261530
Nuremberg, Germany
Praxisklinik Nürnberg /ID# 261682
Nuremberg, Germany
Praxis fuer Gastroenterologie /ID# 266305
Schwerin, Germany
Praxis Dr. Kempelmann /ID# 261583
Tostedt, Germany
Dr. Schirin-Sokhan /ID# 266003
Würselen, Germany
Shaare Zedek Medical Center /ID# 258738
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 258737
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 257057
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center /ID# 257058
Petah Tikva, Israel
Azienda Ospedaliero Universitaria Careggi /ID# 265159
Florence, Firenze, Italy
IRCCS Istituto Clinico Humanitas /ID# 262991
Rozzano, Lombardy, Italy
IRCCS Ospedale San Raffaele /ID# 265127
Milan, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 263918
Rome, Roma, Italy