An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
- Conditions
- Crohn's Disease
- Registration Number
- NCT05841537
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1019
- 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).
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3 At Month 12 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (154)
Dres. Ende / Weisflog /ID# 262038
🇩🇪Erfurt, Germany
MVZ Dres. Al-Kadi & Partner /ID# 260996
🇩🇪Iserlohn, Germany
Dres. Breitschwerdt/Glas/Gurtler /ID# 257612
🇩🇪Leipzig, Germany
Gastropraxis Magdeburg /ID# 261340
🇩🇪Magdeburg, Germany
CHU de CAEN - Hopital de la Cote de Nacre /ID# 253368
🇫🇷Caen, France
Universitaetsklinikum St. Poelten /ID# 258828
🇦🇹Sankt Poelten, Niederoesterreich, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 253558
🇦🇹Wels, Oberoesterreich, Austria
Medizinische Universitaet Graz /ID# 253559
🇦🇹Graz, Steiermark, Austria
Medizinische Universitaet Innsbruck /ID# 253563
🇦🇹Innsbruck, Tirol, Austria
Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824
🇦🇹Vienna, Wien, Austria
Medizinische Universitaet Wien /ID# 261472
🇦🇹Vienna, Wien, 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 Cedex 3, Alpes-Maritimes, France
APHM - Hopital Nord /ID# 253364
🇫🇷Marseille, Bouches-du-Rhone, France
CHU de Besancon - Jean Minjoz /ID# 253098
🇫🇷Besancon, Doubs, France
Hopital de la Cavale Blanche /ID# 253100
🇫🇷Brest, Finistere, France
Centre Hospitalier de Quimper /ID# 254052
🇫🇷Quimper CEDEX, Finistere, France
CHU NIMES - Hopital Caremeau /ID# 254060
🇫🇷Nimes CEDEX 9, Gard, France
Centre Hospitalier Universitaire de Bordeaux /ID# 253095
🇫🇷Pessac CEDEX, Gironde, France
Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 253088
🇫🇷Colmar CEDEX, Grand-Est, France
CHU Toulouse - Hopital Rangueil /ID# 253094
🇫🇷Toulouse, Haute-Garonne, France
CHU Montpellier - Hopital Saint Eloi /ID# 253096
🇫🇷Montpellier Cedex 5, Herault, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 253358
🇫🇷Neuilly Sur Seine, Ile-de-France, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 253102
🇫🇷St-Priest-en-Jarez, Loire, France
CHU Reims - Hôpital Robert Debre /ID# 253366
🇫🇷Reims CEDEX, Marne, France
Centre Hospitalier de Dunkerque /ID# 253837
🇫🇷Dunkirk CEDEX 1, Nord, France
CHRU Lille - Hopital Claude Huriez /ID# 253099
🇫🇷Lille, Nord, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 253091
🇫🇷Creteil, Paris, France
AP-HP - Hopital Bicetre /ID# 253093
🇫🇷Le Kremlin Bicetre, Paris, France
CHU de Nantes, Hotel Dieu -HME /ID# 254047
🇫🇷Nantes, Pays-de-la-Loire, France
HCL - Hopital de la Croix-Rousse /ID# 256413
🇫🇷Lyon, Rhone, France
HCL - Hopital Lyon Sud /ID# 253104
🇫🇷Pierre Benite CEDEX, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 253089
🇫🇷Amiens CEDEX 1, Somme, France
CHRU Tours - Hopital Trousseau /ID# 253369
🇫🇷Chambray Les 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 CEDEX, France
Centre Hospitalier Tarbes-Lourdes /ID# 253943
🇫🇷Tarbes CEDEX 9, France
Hôpital Schuman /ID# 254781
🇫🇷Vantoux, France
Universitaetsklinikum Heidelberg /ID# 272329
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Praxis fuer Gastroenterologie /ID# 260994
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
Medizinisches Versorgunszentrum Dachau /ID# 262592
🇩🇪Dachau, Bayern, Germany
Universitaetsklinikum Erlangen /ID# 269946
🇩🇪Erlangen, Bayern, Germany
Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 262895
🇩🇪Kassel, Hessen, Germany
Mueller/Mueller-Ziehm, Hanover /ID# 261599
🇩🇪Hannover, Niedersachsen, Germany
Gastroenterologische Schwerpunktpraxis /ID# 275444
🇩🇪Hanover, Niedersachsen, Germany
Gastroenterologische Gemeinschaftspraxis Minden /ID# 261148
🇩🇪Minden, Nordrhein-Westfalen, Germany
Magen-Darm-Zentrum-Remscheid /ID# 260681
🇩🇪Remscheid, Nordrhein-Westfalen, Germany
Klinikum Worms gGmbH /ID# 269803
🇩🇪Worms, Rheinland-Pfalz, 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, Sachsen-Anhalt, Germany
Praxis Jessen/Grimm /ID# 257610
🇩🇪Altenholz, Schleswig-Holstein, Germany
Praxis S. Tetzlaff /ID# 257608
🇩🇪Büdelsdorf, 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
Krankenhaus Waldfriede /ID# 262341
🇩🇪Berlin-Zehlendorf, 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
Dr. Janschek /ID# 260993
🇩🇪Dresden, Germany
Dres. Bauer/Doerflinger /ID# 262531
🇩🇪Freiburg im Breisgau, Germany
Dres. Behrens/Fechner/Streudel /ID# 257601
🇩🇪Halle (Saale), Germany
Städtisches Kh. Heinsberg GmbH /ID# 258671
🇩🇪Heinsberg, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 261122
🇩🇪Herne, Germany
Gastro.Praxis am Meerbachbogen /ID# 265900
🇩🇪Nienburg (Weser), 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
The Chaim Sheba Medical Center /ID# 258737
🇮🇱Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 257057
🇮🇱Tel Aviv, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 258738
🇮🇱Jerusalem, Yerushalayim, 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, Lombardia, Italy
IRCCS Ospedale San Raffaele /ID# 265127
🇮🇹Milan, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 263918
🇮🇹Rome, Roma, Italy
A.O.U. Consorziale Policlinico di Bari /ID# 264739
🇮🇹Bari, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 265289
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 263592
🇮🇹Messina, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 263587
🇮🇹Milano, Italy
Nagoya University Hospital /ID# 257302
🇯🇵Nagoya-shi, Aichi, Japan
Hirosaki University Hospital /ID# 256887
🇯🇵Hirosaki-shi, Aomori, Japan
Chiba University Hospital /ID# 256721
🇯🇵Chiba-shi, Chiba, Japan
Toho University Sakura Medical Center /ID# 256668
🇯🇵Sakura-shi, Chiba, Japan
Fukuoka University Chikushi Hospital /ID# 256113
🇯🇵Chikushino-shi, Fukuoka, Japan
Fukuoka University Hospital /ID# 256718
🇯🇵Fukuoka-shi, Fukuoka, Japan
Asahikawa Medical University Hospital /ID# 256842
🇯🇵Asahikawa-shi, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 256544
🇯🇵Sapporo-shi, Hokkaido, Japan
Hyogo Medical University Hospital /ID# 256720
🇯🇵Nishinomiya-shi, Hyogo, Japan
Iwate Medical University Hospital /ID# 256722
🇯🇵Shiwa-gun, Iwate, Japan
Yokohama City University Medical Center /ID# 256719
🇯🇵Yokohama shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 266206
🇯🇵Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 255867
🇯🇵Sendai-shi, Miyagi, Japan
Kansai Medical University Hospital /ID# 256548
🇯🇵Hirakata-shi, Osaka, Japan
Saga University Hospital /ID# 256726
🇯🇵Saga-shi, Saga, Japan
Shiga University of Medical Science Hospital /ID# 256549
🇯🇵Otsu, Shiga, Japan
Hamamatsu University Hospital /ID# 256723
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Jichi Medical University Hospital /ID# 256665
🇯🇵Shimotsuke-shi, Tochigi, Japan
Institute of Science Tokyo Hospital /ID# 256669
🇯🇵Bunkyo-ku, Tokyo, Japan
The Jikei University Hospital /ID# 255741
🇯🇵Minato-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 256724
🇯🇵Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 254076
🇯🇵Mitaka-shi, Tokyo, Japan
Keio University Hospital /ID# 257239
🇯🇵Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 255868
🇯🇵Shinjuku-ku, Tokyo, Japan
Radboudumc /ID# 266526
🇳🇱Nijmegen, Gelderland, Netherlands
Atrium-Orbis - Zuyderland Medisch Centrum Heerlen /ID# 268085
🇳🇱Heerlen, Limburg, Netherlands
Elisabeth TweeSteden Ziekenhuis /ID# 267140
🇳🇱Tilburg, Noord-Brabant, Netherlands
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261195
🇪🇸Santiago de Compostela, A Coruna, Spain
Hospital Universitari de Bellvitge /ID# 261198
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla /ID# 261196
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 261201
🇪🇸Majadahonda, Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 261228
🇪🇸El Palmar, Murcia, Spain
Hospital Alvaro Cunqueiro CHUVI /ID# 261224
🇪🇸Vigo, Pontevedra, Spain
Hospital Juan Ramon Jimenez /ID# 261227
🇪🇸Huelva, Spain
Hospital Universitario 12 de Octubre /ID# 261200
🇪🇸Madrid, Spain
Hospital Universitario La Paz /ID# 261199
🇪🇸Madrid, Spain
Hospital Universitario de Salamanca /ID# 261197
🇪🇸Salamanca, Spain
Hospital Universitario Virgen Macarena /ID# 261225
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocio /ID# 261202
🇪🇸Sevilla, Spain
Hôpital de La Tour /ID# 259489
🇨🇭Meyrin, Geneve, Switzerland
Kantonsspital St. Gallen /ID# 261931
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Gastroentérologie Beaulieu SA /ID# 259490
🇨🇭Lausanne, Vaud, Switzerland
University Hospital Zurich /ID# 259491
🇨🇭Zurich, Zuerich, Switzerland
Hirslanden Klinik /ID# 262093
🇨🇭Zürich, Zuerich, Switzerland
Inselspital, Universitaetsspital Bern /ID# 259485
🇨🇭Bern, Switzerland
Berner IBD Study Group /ID# 259351
🇨🇭Bern, Switzerland
Sheikh Shakhbout Medical City /ID# 276665
🇦🇪Abu Dhabi, United Arab Emirates
Burjeel Day Surgery Center /ID# 259188
🇦🇪Abu Dhabi, United Arab Emirates
Cleveland Clinic Abu Dhabi /ID# 261681
🇦🇪Abu Dhabi, United Arab Emirates
Rashid Hospital /ID# 259264
🇦🇪Dubai, United Arab Emirates