Clinical trial NCT05841537: An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
Official title: A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn's Disease
Keywords: Crohn's Disease
CD
Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 1019
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with Crohn's disease (CD)

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Participants with a diagnosis of Crohn's disease (CD) confirmed by clinical, endoscopic and/or histological indices.
* Participants initiating risankizumab at the clinician's discretion as part of their routine clinical care.
* Participants prescribed risankizumab in accordance with the approved local label.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants willing and able to provide authorization to use and disclose personal health information.
* Participants willing and able to participate in the collection of patient-reported data via cloud-based mobile application using a smart device (i.e., smartphone).

Exclusion Criteria:

* Females who are pregnant or breast feeding at baseline.
* Participants with any contraindication to risankizumab.
* Participants previously exposed to risankizumab.
* Participants currently participating in an interventional clinical trial.

Primary outcomes:
measure: Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3
timeFrame: At Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 258828
state: Niederoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH /ID# 253558
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 253559
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck /ID# 253563
state: Tirol
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824
state: Wien
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 261472
state: Wien
city: Calgary
country: Canada
facility: University of Calgary /ID# 254511
state: Alberta
city: Edmonton
country: Canada
facility: Gastroenterology and Internal Medicine Research Institution /ID# 253319
state: Alberta
city: Edmonton
country: Canada
facility: South Edmonton Gastroenterology Research Clinic /ID# 253160
state: Alberta
city: Lethbridge
country: Canada
facility: Six08 Gastroenterology /ID# 254513
state: Alberta
city: Kelowna
country: Canada
facility: Dr. Sundeep Singh, Inc /ID# 254250
state: British Columbia
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc /ID# 254512
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 256339
state: British Columbia
city: Moncton
country: Canada
facility: The Moncton Hospital /ID# 252960
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661
state: Ontario
city: North Bay
country: Canada
facility: Scott Shulman Medicine Professional Corporation /ID# 252961
state: Ontario
city: North York
country: Canada
facility: Physician's Clinical Research Inc. /ID# 256494
state: Ontario
city: North York
country: Canada
facility: Toronto Immune and Digestive Health Institute Inc /ID# 253946
state: Ontario
city: Oshawa
country: Canada
facility: Taunton surgical centre /ID# 253812
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates /ID# 253813
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 254626
state: Quebec
city: Québec
country: Canada
facility: Diex Recherche Québec /ID# 254016
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS /ID# 254591
state: Quebec
city: Nice Cedex 3
country: France
facility: Hôpital l'Archet /ID# 253097
state: Alpes-Maritimes
city: Marseille
country: France
facility: APHM - Hopital Nord /ID# 253364
state: Bouches-du-Rhone
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 253098
state: Doubs
city: Brest
country: France
facility: Hopital de la Cavale Blanche /ID# 253100
state: Finistere
city: Quimper CEDEX
country: France
facility: Centre Hospitalier de Quimper /ID# 254052
state: Finistere
city: Nimes CEDEX 9
country: France
facility: CHU NIMES - Hopital Caremeau /ID# 254060
state: Gard
city: Pessac CEDEX
country: France
facility: Centre Hospitalier Universitaire de Bordeaux /ID# 253095
state: Gironde
city: Colmar CEDEX
country: France
facility: Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 253088
state: Grand-Est
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Rangueil /ID# 253094
state: Haute-Garonne
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 253096
state: Herault
city: Neuilly Sur Seine
country: France
facility: Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 253358
state: Ile-de-France
city: St-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 253102
state: Loire
city: Reims CEDEX
country: France
facility: CHU Reims - Hôpital Robert Debre /ID# 253366
state: Marne
city: Dunkirk CEDEX 1
country: France
facility: Centre Hospitalier de Dunkerque /ID# 253837
state: Nord
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 253099
state: Nord
city: Creteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 253091
state: Paris
city: Le Kremlin Bicetre
country: France
facility: AP-HP - Hopital Bicetre /ID# 253093
state: Paris
city: Nantes
country: France
facility: CHU de Nantes, Hotel Dieu -HME /ID# 254047
state: Pays-de-la-Loire
city: Lyon
country: France
facility: HCL - Hopital de la Croix-Rousse /ID# 256413
state: Rhone
city: Pierre Benite CEDEX
country: France
facility: HCL - Hopital Lyon Sud /ID# 253104
state: Rhone
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 253089
state: Somme
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 253368
city: Chambray Les Tours
country: France
facility: CHRU Tours - Hopital Trousseau /ID# 253369
city: Charenton le Pont
country: France
facility: Clinique de Bercy /Id# 253139
city: Epagny Metz Tessy
country: France
facility: CH Annecy Genevois - Site Annecy /ID# 253103
city: Haguenau
country: France
facility: CH Haguenau /ID# 253109
city: Nantes
country: France
facility: Clinique Jules Verne /ID# 253939
city: Paris
country: France
facility: AP-HP - Hopital Saint-Antoine /ID# 254044
city: Rouen CEDEX
country: France
facility: CHU de Rouen /ID# 253107
city: Tarbes CEDEX 9
country: France
facility: Centre Hospitalier Tarbes-Lourdes /ID# 253943
city: Vantoux
country: France
facility: Hôpital Schuman /ID# 254781
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg /ID# 272329
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 260994
state: Baden-Wuerttemberg
city: Dachau
country: Germany
facility: Medizinisches Versorgunszentrum Dachau /ID# 262592
state: Bayern
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 269946
state: Bayern
city: Kassel
country: Germany
facility: Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 262895
state: Hessen
city: Hannover
country: Germany
facility: Mueller/Mueller-Ziehm, Hanover /ID# 261599
state: Niedersachsen
city: Hanover
country: Germany
facility: Gastroenterologische Schwerpunktpraxis /ID# 275444
state: Niedersachsen
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 261148
state: Nordrhein-Westfalen
city: Remscheid
country: Germany
facility: Magen-Darm-Zentrum-Remscheid /ID# 260681
state: Nordrhein-Westfalen
city: Worms
country: Germany
facility: Klinikum Worms gGmbH /ID# 269803
state: Rheinland-Pfalz
city: Friedrichsthal
country: Germany
facility: Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 261361
state: Saarland
city: Saarbrücken
country: Germany
facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 257602
state: Saarland
city: Jerichow
country: Germany
facility: Praxisgemeinschaft Jerichow Schulze /ID# 262036
state: Sachsen-Anhalt
city: Altenholz
country: Germany
facility: Praxis Jessen/Grimm /ID# 257610
state: Schleswig-Holstein
city: Büdelsdorf
country: Germany
facility: Praxis S. Tetzlaff /ID# 257608
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 257607
state: Schleswig-Holstein
city: Andernach
country: Germany
facility: Praxis Heil & Mueller /ID# 265211
city: Augsburg
country: Germany
facility: Praxis Dr. Schiffelholz /ID# 265218
city: Berlin-Zehlendorf
country: Germany
facility: Krankenhaus Waldfriede /ID# 262341
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 262462
city: Berlin
country: Germany
facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 260995
city: Berlin
country: Germany
facility: Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262711
city: Dresden
country: Germany
facility: Dr. Janschek /ID# 260993
city: Erfurt
country: Germany
facility: Dres. Ende / Weisflog /ID# 262038
city: Freiburg im Breisgau
country: Germany
facility: Dres. Bauer/Doerflinger /ID# 262531
city: Halle (Saale)
country: Germany
facility: Dres. Behrens/Fechner/Streudel /ID# 257601
city: Heinsberg
country: Germany
facility: Städtisches Kh. Heinsberg GmbH /ID# 258671
city: Herne
country: Germany
facility: GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 261122
city: Iserlohn
country: Germany
facility: MVZ Dres. Al-Kadi & Partner /ID# 260996
city: Leipzig
country: Germany
facility: Dres. Breitschwerdt/Glas/Gurtler /ID# 257612
city: Magdeburg
country: Germany
facility: Gastropraxis Magdeburg /ID# 261340
city: Nienburg (Weser)
country: Germany
facility: Gastro.Praxis am Meerbachbogen /ID# 265900
city: Nuremberg
country: Germany
facility: Dres. Hundorfean/Tex /ID# 261530
city: Nuremberg
country: Germany
facility: Praxisklinik Nürnberg /ID# 261682
city: Schwerin
country: Germany
facility: Praxis fuer Gastroenterologie /ID# 266305
city: Tostedt
country: Germany
facility: Praxis Dr. Kempelmann /ID# 261583
city: Würselen
country: Germany
facility: Dr. Schirin-Sokhan /ID# 266003
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 258737
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 257057
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 258738
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 257058
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 265159
state: Firenze
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas /ID# 262991
state: Lombardia
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 265127
state: Milano
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 263918
state: Roma
city: Bari
country: Italy
facility: A.O.U. Consorziale Policlinico di Bari /ID# 264739
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 265289
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Gaetano Martino /ID# 263592
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 263587
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 257302
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital /ID# 256887
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba University Hospital /ID# 256721
state: Chiba
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center /ID# 256668
state: Chiba
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital /ID# 256113
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 256718
state: Fukuoka
city: Asahikawa-shi
country: Japan
facility: Asahikawa Medical University Hospital /ID# 256842
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital /ID# 256544
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 256720
state: Hyogo
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital /ID# 256722
state: Iwate
city: Yokohama shi
country: Japan
facility: Yokohama City University Medical Center /ID# 256719
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 266206
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 255867
state: Miyagi
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 256548
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital /ID# 256726
state: Saga
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital /ID# 256549
state: Shiga
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 256723
state: Shizuoka
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital /ID# 256665
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital /ID# 256669
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital /ID# 255741
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital /ID# 256724
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital /ID# 254076
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 257239
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 255868
state: Tokyo
city: Nijmegen
country: Netherlands
facility: Radboudumc /ID# 266526
state: Gelderland
city: Heerlen
country: Netherlands
facility: Atrium-Orbis - Zuyderland Medisch Centrum Heerlen /ID# 268085
state: Limburg
city: Tilburg
country: Netherlands
facility: Elisabeth TweeSteden Ziekenhuis /ID# 267140
state: Noord-Brabant
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261195
state: A Coruna
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge /ID# 261198
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 261196
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda /ID# 261201
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 261228
state: Murcia
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro CHUVI /ID# 261224
state: Pontevedra
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez /ID# 261227
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 261200
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 261199
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 261197
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 261225
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 261202
city: Meyrin
country: Switzerland
facility: Hôpital de La Tour /ID# 259489
state: Geneve
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 261931
state: Sankt Gallen
city: Lausanne
country: Switzerland
facility: Gastroentérologie Beaulieu SA /ID# 259490
state: Vaud
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 259491
state: Zuerich
city: Zürich
country: Switzerland
facility: Hirslanden Klinik /ID# 262093
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 259485
city: Bern
country: Switzerland
facility: Berner IBD Study Group /ID# 259351
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City /ID# 276665
city: Abu Dhabi
country: United Arab Emirates
facility: Burjeel Day Surgery Center /ID# 259188
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi /ID# 261681
city: Dubai
country: United Arab Emirates
facility: Rashid Hospital /ID# 259264
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: