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NCT05841537 Clinical Trial

An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

Crohn's Disease Clinical Trial

— APPRISE  

Official title:
A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05841537
Other study ID # P22-920
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 9, 2023
Est. completion date January 31, 2028

Study information
Verified date June 2024
Source AbbVie
Contact Sahi Alapati
Email sahi.alapati@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date January 31, 2028
Est. primary completion date January 31, 2028
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Medizinische Universitaet Graz /ID# 253559 Graz Steiermark
Austria Medizinische Universitaet Innsbruck /ID# 253563 Innsbruck Tirol
Austria Universitaetsklinikum St. Poelten /ID# 258828 Sankt Poelten Niederoesterreich
Austria Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824 Vienna Wien
Austria Medizinische Universitaet Wien /ID# 261472 Vienna Wien
Austria Klinikum Wels-Grieskirchen GmbH /ID# 253558 Wels Oberoesterreich
Canada 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 Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661 Hamilton Ontario
Canada Dr. Sundeep Singh, Inc /ID# 254250 Kelowna British Columbia
Canada Six08 Gastroenterology /ID# 254513 Lethbridge Alberta
Canada The Moncton Hospital /ID# 252960 Moncton New Brunswick
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 Fraser Clinical Trials Inc /ID# 254512 New Westminster British Columbia
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 Diex Recherche Québec Inc. /ID# 254016 Québec Quebec
Canada CIUSSS de l'Estrie - CHUS /ID# 254591 Sherbrooke Quebec
Canada Toronto Digestive Disease Associates, Inc. /ID# 253813 Vaughan Ontario
Canada Percuro Clinical Research, Ltd /ID# 256339 Victoria British Columbia
France Hopital de la Cavale Blanche /ID# 253100 Brest Finistere
France Centre Hospitalier de Quimper /ID# 254052 Quimper CEDEX Finistere
Germany Praxis Jessen/Grimm /ID# 257610 Altenholz Schleswig-Holstein
Germany Praxis Heil & Mueller /ID# 265211 Andernach
Germany Praxis Dr. Schiffelholz /ID# 265218 Augsburg
Germany Charité Universitätsmedizin 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 Praxis S. Tetzlaff /ID# 257608 Büdelsdorf Schleswig-Holstein
Germany Medizinisches Versorgunszentrum Dachau /ID# 262592 Dachau
Germany Dr. Janschek /ID# 260993 Dresden
Germany Dres. Ende / Weisflog /ID# 262038 Erfurt
Germany Dres. Bauer/Doerflinger /ID# 262531 Freiburg im Breisgau
Germany Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 261361 Friedrichsthal Saarland
Germany Dres. Behrens/Fechner/Streudel /ID# 257601 Halle (Saale)
Germany Mueller/Mueller-Ziehm, Hanover /ID# 261599 Hannover
Germany Praxis fuer Gastroenterologie /ID# 260994 Heidelberg Baden-Wuerttemberg
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 Praxis Dr. Schulze /ID# 262036 Jerichow
Germany Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 262895 Kassel
Germany Dres. Breitschwerdt/Glas/Gurtler /ID# 257612 Leipzig
Germany Dres. Schmidt/Büning/Bär, Praxis für Gastroenterologie /ID# 257607 Lübeck Schleswig-Holstein
Germany Gastropraxis Magdeburg /ID# 261340 Magdeburg
Germany Gastroenterologische Gemeinschaftspraxis Minden /ID# 261148 Minden
Germany Gastro.Praxis am Meerbachbogen /ID# 265900 Nienburg (Weser)
Germany Dres. Hundorfean/Tex /ID# 261530 Nuremberg
Germany Praxisklinik Nürnberg /ID# 261682 Nuremberg
Germany Magen-Darm-Zentrum-Remscheid /ID# 260681 Remscheid Nordrhein-Westfalen
Germany Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 257602 Saarbrücken Saarland
Germany Praxis fuer Gastroenterologie /ID# 266305 Schwerin
Germany Praxis Dr. Kempelmann /ID# 261583 Tostedt
Germany Dr. Schirin-Sokhan /ID# 266003 Würselen
Israel Rabin Medical Center /ID# 257058 Haifa
Israel Shaare Zedek Medical Center /ID# 258738 Jerusalem Yerushalayim
Israel The Chaim Sheba Medical Center /ID# 258737 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 257057 Tel Aviv Tel-Aviv
Japan Asahikawa Medical University Hospital /ID# 256842 Asahikawa-shi Hokkaido
Japan Tokyo Medical And Dental University Hospital /ID# 256669 Bunkyo-ku Tokyo
Japan Chiba University Hospital /ID# 256721 Chiba-shi Chiba
Japan Fukuoka University Chikushi Hospital /ID# 256113 Chikushino-shi Fukuoka
Japan Fukuoka University Hospital /ID# 256718 Fukuoka-shi Fukuoka
Japan Hamamatsu University Hospital /ID# 256723 Hamamatsu-shi Shizuoka
Japan Kansai Medical University Hospital /ID# 256548 Hirakata-shi Osaka
Japan Hirosaki University Hospital /ID# 256887 Hirosaki-shi Aomori
Japan Kitasato University Kitasato Institute Hospital /ID# 256724 Minato-ku Tokyo
Japan The Jikei University Hospital /ID# 255741 Minato-ku Tokyo
Japan Kyorin University - Mitaka Campus /ID# 254076 Mitaka
Japan Nagoya University Hospital /ID# 257302 Nagoya-shi Aichi
Japan Hyogo Medical University Hospital /ID# 256720 Nishinomiya-shi Hyogo
Japan Shiga University of Medical Science Hospital /ID# 256549 Otsu-shi Shiga
Japan Saga University Hospital /ID# 256726 Saga-shi Saga
Japan Toho University Sakura Medical Center /ID# 256668 Sakura-shi Chiba
Japan Sapporo Medical University Hospital /ID# 256544 Sapporo-shi Hokkaido
Japan Tohoku University Hospital /ID# 255867 Sendai-shi Miyagi
Japan Jichi Medical University Hospital /ID# 256665 Shimotsuke-shi Tochigi
Japan Keio University Hospital /ID# 257239 Shinjuku-ku Tokyo
Japan Tokyo Women's Medical University Hospital /ID# 255868 Shinjuku-ku Tokyo
Japan Iwate Medical University Hospital /ID# 256722 Shiwa-gun Iwate
Japan Yokohama City University Medical Center /ID# 256719 Yokohama shi Kanagawa
Spain Hospital Clinico Universitario Virgen de la Arrixaca /ID# 261228 El Palmar Murcia
Spain Hospital Juan Ramon Jimenez /ID# 261227 Huelva
Spain Hospital Universitari de Bellvitge /ID# 261198 L'Hospitalet de Llobregat Barcelona
Spain Hospital Universitario 12 de Octubre /ID# 261200 Madrid
Spain Hospital Universitario La Paz /ID# 261199 Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda /ID# 261201 Majadahonda Madrid
Spain Hospital Universitario de Salamanca /ID# 261197 Salamanca
Spain Hospital Universitario Marques de Valdecilla /ID# 261196 Santander Cantabria
Spain Hospital Clínico Universitario de Santiago-CHUS /ID# 261195 Santiago de Compostela A Coruna
Spain Hospital Universitario Virgen del Rocio /ID# 261202 Sevilla
Spain Hospital Universitario Virgen Macarena /ID# 261225 Sevilla
Spain Hospital Alvaro Cunqueiro CHUVI /ID# 261224 Vigo Pontevedra
Switzerland Berner IBD Study Group /ID# 259351 Bern
Switzerland Inselspital, Universitaetsspital Bern /ID# 259485 Bern
Switzerland Gastroentérologie Beaulieu SA /ID# 259490 Lausanne Vaud
Switzerland Hôpital de La Tour /ID# 259489 Meyrin Geneve
Switzerland Kantonsspital St. Gallen /ID# 261931 St. Gallen Sankt Gallen
Switzerland Hirslanden Zürich /ID# 262093 Zurich
Switzerland University Hospital Zurich /ID# 259491 Zurich Zuerich
United Arab Emirates Burjeel Day Surgery Center /ID# 259188 Abu Dhabi

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Austria,  Canada,  France,  Germany,  Israel,  Japan,  Spain,  Switzerland,  United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3 Clinical Remission is defined as HBI <= 4. Clinical Response is defined as HBI reduction >= 3 points. The HBI is a simplified version of the Crohn's Disease Activity Index(CDAI). The HBI consists of 5 items encompassing patient-reported (well-being, symptoms) and objective (presence of abdominal mass or complications) variables. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity. Scores < 5 indicate clinical remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease. At Month 12
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