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Crohn's DiseaseAPPRISENCT05841537

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

An observational study of Crohn's Disease, run by AbbVie at 154 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Crohn's Disease
How many people
1,019 participants
Where
154 sitesin 11 countries
Study dates
9 Jun 2023to Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adult participants with Crohn's disease (CD)

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

154 sites in 11 countries.

154 sites in 11 countries

Germany37 sites

  • Praxis Jessen/Grimm /ID# 257610

    Altenholz, Schleswig-Holstein, 24161

  • Praxis Heil & Mueller /ID# 265211

    Andernach, 56626

  • Praxis Dr. Schiffelholz /ID# 265218

    Augsburg, 86150

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 262462

    Berlin, 10117

  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 260995

    Berlin, 10825

  • Zweite Gemeinnuutzige Krankenhaus GmbH DRK Kliniken Berlin Kopenick /ID# 262711

    Berlin, 12559

  • Krankenhaus Waldfriede /ID# 262341

    Berlin-Zehlendorf, 14163

  • Praxis S. Tetzlaff /ID# 257608

    Buedelsdorf, Schleswig-Holstein, 24782

  • Medizinisches Versorgunszentrum Dachau /ID# 262592

    Dachau, Bavaria, 85221

  • Dr. Janschek /ID# 260993

    Dresden, 01309

  • Dres. Ende / Weisflog /ID# 262038

    Erfurt, 99084

  • Universitaetsklinikum Erlangen /ID# 269946

    Erlangen, Bavaria, 91054

  • Dres. Bauer/Doerflinger /ID# 262531

    Freiburg im Breisgau, 79102

  • Gemeinschaftspraxis Drs. Denger und Pfitzner /ID# 261361

    Friedrichsthal, Saarland, 66299

  • Dres. Behrens/Fechner/Streudel /ID# 257601

    Halle, 06108

  • Gastroenterologische Schwerpunktpraxis /ID# 275444

    Hanover, Lower Saxony, 30449

  • Mueller/Mueller-Ziehm, Hanover /ID# 261599

    Hanover, Lower Saxony, 30449

  • Universitaetsklinikum Heidelberg /ID# 272329

    Heidelberg, Baden-Wurttemberg, 69120

  • Praxis fuer Gastroenterologie /ID# 260994

    Heidelberg, Baden-Wurttemberg, 69121

  • Städtisches Kh. Heinsberg GmbH /ID# 258671

    Heinsberg, 52525

  • GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 261122

    Herne, 44623

  • MVZ Dres. Al-Kadi & Partner /ID# 260996

    Iserlohn, 58644

  • Praxisgemeinschaft Jerichow Schulze /ID# 262036

    Jerichow, Saxony-Anhalt, 39319

  • Gastroenterologie Opernstrasse Private Practice - Dr. Falk & Krause & Kuhn /ID# 262895

    Kassel, Hesse, 34117

  • Dres. Breitschwerdt/Glas/Gurtler /ID# 257612

    Leipzig, 04107

  • Praxis fuer Gastroenterologie /ID# 257607

    Lübeck, Schleswig-Holstein, 23560

  • Gastropraxis Magdeburg /ID# 261340

    Magdeburg, 39104

  • Gastroenterologische Gemeinschaftspraxis Minden /ID# 261148

    Minden, North Rhine-Westphalia, 32423

  • Gastro.Praxis am Meerbachbogen /ID# 265900

    Nienburg, 31582

  • Dres. Hundorfean/Tex /ID# 261530

    Nuremberg, 90409

  • Praxisklinik Nürnberg /ID# 261682

    Nuremberg, 90449

  • Magen-Darm-Zentrum-Remscheid /ID# 260681

    Remscheid, North Rhine-Westphalia, 42859

  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 257602

    Saarbrücken, Saarland, 66111

  • Praxis fuer Gastroenterologie /ID# 266305

    Schwerin, 19057

  • Praxis Dr. Kempelmann /ID# 261583

    Tostedt, 21255

  • Klinikum Worms gGmbH /ID# 269803

    Worms, Rhineland-Palatinate, 67550

  • Dr. Schirin-Sokhan /ID# 266003

    Würselen, 52146

Other trials in Germany

France31 sites

  • CHU Amiens-Picardie Site Sud /ID# 253089

    Amiens, Somme, 80054

  • CHU de Besancon - Jean Minjoz /ID# 253098

    Besançon, Doubs, 25030

  • Hopital de la Cavale Blanche /ID# 253100

    Brest, Finistere, 29200

  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 253368

    Caen, 14033

  • CHRU Tours - Hopital Trousseau /ID# 253369

    Chambray-lès-Tours, 37170

  • Clinique de Bercy /Id# 253139

    Charenton-le-Pont, 94220

  • Hôpitaux Civils de Colmar - Hôpital Pasteur /ID# 253088

    Colmar, Grand Est, 68024

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 253091

    Créteil, Paris, 94010

  • Centre Hospitalier de Dunkerque /ID# 253837

    Dunkirk, Nord, 59385

  • CH Annecy Genevois - Site Annecy /ID# 253103

    Epagny Metz Tessy, 74370

  • CH Haguenau /ID# 253109

    Haguenau, 67500

  • AP-HP - Hopital Bicetre /ID# 253093

    Le Kremlin-Bicêtre, Paris, 94270

  • CHRU Lille - Hopital Claude Huriez /ID# 253099

    Lille, Nord, 59037

  • HCL - Hopital de la Croix-Rousse /ID# 256413

    Lyon, Rhone, 69004

  • APHM - Hopital Nord /ID# 253364

    Marseille, Bouches-du-Rhone, 13015

  • CHU Montpellier - Hopital Saint Eloi /ID# 253096

    Montpellier, Herault, 34295

  • CHU de Nantes, Hotel Dieu -HME /ID# 254047

    Nantes, Pays de la Loire Region, 44000

  • Clinique Jules Verne /ID# 253939

    Nantes, 44300

  • Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 253358

    Neuilly-sur-Seine, Île-de-France Region, 92200

  • Hôpital l'Archet /ID# 253097

    Nice, Alpes-Maritimes, 06202

  • CHU NIMES - Hopital Caremeau /ID# 254060

    Nîmes, Gard, 30029

  • AP-HP - Hopital Saint-Antoine /ID# 254044

    Paris, 75012

  • Centre Hospitalier Universitaire de Bordeaux /ID# 253095

    Pessac, Gironde, 33604

  • HCL - Hopital Lyon Sud /ID# 253104

    Pierre-Bénite, Rhone, 69495

  • Centre Hospitalier de Quimper /ID# 254052

    Quimper, Finistere, 29107

  • CHU Reims - Hôpital Robert Debre /ID# 253366

    Reims, Marne, 51092

  • CHU de Rouen /ID# 253107

    Rouen, 76031

  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 253102

    St-Priest-en-Jarez, Pays de la Loire Region, 42270

  • Centre Hospitalier Tarbes-Lourdes /ID# 253943

    Tarbes, 65013

  • CHU Toulouse - Hopital Rangueil /ID# 253094

    Toulouse, Haute-Garonne, 31400

  • Hôpital Schuman /ID# 254781

    Vantoux, 57070

Other trials in France

Japan24 sites

  • Asahikawa Medical University Hospital /ID# 256842

    Asahikawa-shi, Hokkaido, 078-8510

  • Institute of Science Tokyo Hospital /ID# 256669

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital /ID# 256721

    Chiba, Chiba, 260-8677

  • Fukuoka University Chikushi Hospital /ID# 256113

    Chikushino-shi, Fukuoka, 818-8502

  • Fukuoka University Hospital /ID# 256718

    Fukuoka, Fukuoka, 814-0180

  • Hamamatsu University Hospital /ID# 256723

    Hamamatsu, Shizuoka, 431-3192

  • Kansai Medical University Hospital /ID# 256548

    Hirakata-shi, Osaka, 573-1191

  • Hirosaki University Hospital /ID# 256887

    Hirosaki-shi, Aomori, 036-8203

  • University Hospital Kyoto Prefectural University of Medicine /ID# 266206

    Kyoto, Kyoto, 602-8566

  • The Jikei University Hospital /ID# 255741

    Minato-ku, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital /ID# 256724

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 254076

    Mitaka-shi, Tokyo, 181-8611

  • Nagoya University Hospital /ID# 257302

    Nagoya, Aichi-ken, 466-8560

  • Hyogo Medical University Hospital /ID# 256720

    Nishinomiya-shi, Hyōgo, 663-8501

  • Shiga University of Medical Science Hospital /ID# 256549

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital /ID# 256726

    Saga, Saga-ken, 849-8501

  • Toho University Sakura Medical Center /ID# 256668

    Sakura-shi, Chiba, 285-8741

  • Sapporo Medical University Hospital /ID# 256544

    Sapporo, Hokkaido, 060-8543

  • Tohoku University Hospital /ID# 255867

    Sendai, Miyagi, 9808574

  • Jichi Medical University Hospital /ID# 256665

    Shimotsuke-shi, Tochigi, 329-0498

  • Keio University Hospital /ID# 257239

    Shinjuku-ku, Tokyo, 160-8582

  • Tokyo Women's Medical University Hospital /ID# 255868

    Shinjuku-ku, Tokyo, 162-8666

  • Iwate Medical University Hospital /ID# 256722

    Shiwa-gun, Iwate, 028-3695

  • Yokohama City University Medical Center /ID# 256719

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Canada18 sites

  • University of Calgary /ID# 254511

    Calgary, Alberta, T2N 4Z6

  • Gastroenterology and Internal Medicine Research Institution /ID# 253319

    Edmonton, Alberta, T5R 1W2

  • South Edmonton Gastroenterology Research Clinic /ID# 253160

    Edmonton, Alberta, T6K 4B2

  • Hamilton Health Sciences - McMaster University Medical Centre /ID# 255661

    Hamilton, Ontario, L8S 4K1

  • Dr. Sundeep Singh, Inc /ID# 254250

    Kelowna, British Columbia, V1Y 6J6

  • Six08 Gastroenterology /ID# 254513

    Lethbridge, Alberta, T1J 4G9

  • The Moncton Hospital /ID# 252960

    Moncton, New Brunswick, E1C 6Z8

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253522

    Montreal, Quebec, H1T 2M4

  • Royal Victoria Hospital / McGill University Health Centre /ID# 254626

    Montreal, Quebec, H4A 3J1

  • Fraser Clinical Trials Inc /ID# 254512

    New Westminster, British Columbia, V3L 3W4

  • Scott Shulman Medicine Professional Corporation /ID# 252961

    North Bay, Ontario, P1B 2H3

  • Physician's Clinical Research Inc. /ID# 256494

    North York, Ontario, M2K 2W2

  • Toronto Immune and Digestive Health Institute Inc /ID# 253946

    North York, Ontario, M6A 3B4

  • Taunton surgical centre /ID# 253812

    Oshawa, Ontario, L1H 7K4

  • Diex Recherche Québec /ID# 254016

    Québec, Quebec, G1V 4T3

  • CIUSSS de l'Estrie - CHUS /ID# 254591

    Sherbrooke, Quebec, J1G 2E8

  • Toronto Digestive Disease Associates /ID# 253813

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research, Ltd /ID# 256339

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Spain12 sites

  • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 261228

    El Palmar, Murcia, 30120

  • Hospital Juan Ramon Jimenez /ID# 261227

    Huelva, 21005

  • Hospital Universitari de Bellvitge /ID# 261198

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario 12 de Octubre /ID# 261200

    Madrid, 28041

  • Hospital Universitario La Paz /ID# 261199

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 261201

    Majadahonda, Madrid, 28222

  • Hospital Universitario de Salamanca /ID# 261197

    Salamanca, 37711

  • Hospital Universitario Marques de Valdecilla /ID# 261196

    Santander, Cantabria, 39008

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 261195

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen Macarena /ID# 261225

    Seville, 41009

  • Hospital Universitario Virgen del Rocio /ID# 261202

    Seville, 41013

  • Hospital Alvaro Cunqueiro CHUVI /ID# 261224

    Vigo, Pontevedra, 36213

Other trials in Spain

Italy8 sites

  • A.O.U. Consorziale Policlinico di Bari /ID# 264739

    Bari, 70124

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 265289

    Bologna, 40138

  • Azienda Ospedaliero Universitaria Careggi /ID# 265159

    Florence, Firenze, 50134

  • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 263592

    Messina, 98125

  • IRCCS Ospedale San Raffaele /ID# 265127

    Milan, Milano, 20132

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 263587

    Milan, 20122

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 263918

    Rome, Roma, 00133

  • IRCCS Istituto Clinico Humanitas /ID# 262991

    Rozzano, Lombardy, 20089

Other trials in Italy

Switzerland7 sites

  • Inselspital, Universitaetsspital Bern /ID# 259485

    Bern, 3010

  • Berner IBD Study Group /ID# 259351

    Bern, 3012

  • Gastroentérologie Beaulieu SA /ID# 259490

    Lausanne, Canton of Vaud, 1004

  • Hôpital de La Tour /ID# 259489

    Meyrin, Canton of Geneva, 1217

  • Kantonsspital St. Gallen /ID# 261931

    Sankt Gallen, Canton of St. Gallen, 9007

  • University Hospital Zurich /ID# 259491

    Zurich, Canton of Zurich, 8006

  • Hirslanden Klinik /ID# 262093

    Zurich, Canton of Zurich, 8032

Other trials in Switzerland

Austria6 sites

  • Medizinische Universitaet Graz /ID# 253559

    Graz, Styria, 8010

  • Medizinische Universitaet Innsbruck /ID# 253563

    Innsbruck, Tyrol, 6020

  • Universitaetsklinikum St. Poelten /ID# 258828

    Sankt Pölten, Lower Austria, 3100

  • Krankenhaus der Barmherzigen Schwestern Wien Betriebsgesellschaft m.b.H. /ID# 258824

    Vienna, State of Vienna, 1060

  • Medizinische Universitaet Wien /ID# 261472

    Vienna, State of Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH /ID# 253558

    Wels, Upper Austria, 4600

Other trials in Austria

Israel4 sites

  • Shaare Zedek Medical Center /ID# 258738

    Jerusalem, Jerusalem, 91031

  • Rabin Medical Center /ID# 257058

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 258737

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 257057

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

United Arab Emirates4 sites

  • Sheikh Shakhbout Medical City /ID# 276665

    Abu Dhabi, 11001

  • Burjeel Day Surgery Center /ID# 259188

    Abu Dhabi, 113818

  • Cleveland Clinic Abu Dhabi /ID# 261681

    Abu Dhabi

  • Rashid Hospital /ID# 259264

    Dubai

Other trials in United Arab Emirates

Netherlands3 sites

  • Atrium-Orbis - Zuyderland Medisch Centrum Heerlen /ID# 268085

    Heerlen, Limburg, 6419 PC

  • Radboudumc /ID# 266526

    Nijmegen, Gelderland, 6525 GA

  • Elisabeth TweeSteden Ziekenhuis /ID# 267140

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

About this study

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

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.

Read more

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.

Conditions
Crohn's Disease
Keywords
Crohn's Disease, CD, Risankizumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05841537
Study groupRoleWhat they receive
RisankizumabParticipants will receive risankizumab as prescribed by their physician according to local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start9 Jun 2023
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,019 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05841537
Sponsor's protocol ID
P22-920
Acronym
APPRISE
Status last verified
May 2025
First submitted
24 Apr 2023
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by AbbVie at 154 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in Germany, France, Japan, Canada, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Clinical Remission among Participants with Clinical Response at Month 3 (time frame: At Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05841537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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