Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

NCT ID: NCT05930275

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-19

Study Completion Date

2028-09-30

Brief Summary

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Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

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

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of moderate-to-severe crohn's disease (CD).
* Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
* Participants prescribed upadacitinib in accordance with the approved local label.
* Able to understand and communicate with the investigator and comply with the requirements of the study.
* Willing to continue with study documentation after cessation of upadacitinib.
* Willing and able to participate in the collection of PRO data via a cloud-based application on their personal or provided mobile phone or website app.

Exclusion Criteria

* Any contraindication to upadacitinib.
* Previously exposure to upadacitinib in a clinical trial.
* Currently participating in interventional research (not including non-interventional study, post-marketing observational study (PMOS) , or registry participation).
* Initiation of upadacitinib prior to enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Blacktown Hospital /ID# 258574

Blacktown, New South Wales, Australia

Site Status

Macquarie University Hospital /ID# 268722

Macquarie University, New South Wales, Australia

Site Status

Mater Misericordiae Limited /ID# 258535

South Brisbane, Queensland, Australia

Site Status

Ibd Sa /Id# 268335

Kurralta Park, South Australia, Australia

Site Status

The Queen Elizabeth Hospital /ID# 258536

Woodville South, South Australia, Australia

Site Status

Monash Health - Monash Medical Centre /ID# 258538

Clayton, Victoria, Australia

Site Status

The Alfred Hospital /ID# 258537

Melbourne, Victoria, Australia

Site Status

Gastro Med EOOD /ID# 267777

Pazardzhik, Plovdiv, Bulgaria

Site Status

ET dr Nikolay Tsonev /ID# 267584

Samokov, Sofia, Bulgaria

Site Status

MC Higia HB /ID# 267575

Sofiya, Sofia, Bulgaria

Site Status

Umbal Kaspela /ID# 267562

Plovdiv, , Bulgaria

Site Status

Diagnostic consultative center Focus-5 /ID# 267576

Sofia, , Bulgaria

Site Status

Diagnostic consultative center Focus-5 /ID# 268600

Sofia, , Bulgaria

Site Status

AIPSMP dr Mirchev EOOD /ID# 267583

Varna, , Bulgaria

Site Status

MC Nadejda Femily EOOD /ID# 267585

Varna, , Bulgaria

Site Status

DCC Mladost M /ID# 267586

Varna, , Bulgaria

Site Status

Foothills Medical Centre /ID# 263475

Calgary, Alberta, Canada

Site Status

Dr. J Siffledeen Profess Pract /ID# 262713

Edmonton, Alberta, Canada

Site Status

Fraser Clinical Trials Inc /ID# 262347

New Westminster, British Columbia, Canada

Site Status

University of Manitoba & Shared Health /ID# 265853

Winnipeg, Manitoba, Canada

Site Status

Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 262764

Halifax, Nova Scotia, Canada

Site Status

Barrie GI Associates /ID# 268436

Barrie, Ontario, Canada

Site Status

London Health Sciences Center- University Hospital /ID# 262693

London, Ontario, Canada

Site Status

West GTA Endoscopy /ID# 262946

Mississauga, Ontario, Canada

Site Status

Scott Shulman Medicine Professional Corporation /ID# 262060

North Bay, Ontario, Canada

Site Status

Toronto Immune and Digestive Health Institute Inc /ID# 262540

North York, Ontario, Canada

Site Status

ABP Research Services Corp. /ID# 263111

Oakville, Ontario, Canada

Site Status

Toronto Digestive Disease Associates /ID# 262050

Vaughan, Ontario, Canada

Site Status

Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 266264

Montreal, Quebec, Canada

Site Status

Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 262692

Montreal, Quebec, Canada

Site Status

Diex Recherche Quebec Inc. /ID# 268256

Québec, , Canada

Site Status

Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 265873

Beijing, Beijing Municipality, China

Site Status

Chongqing General Hospital /ID# 268384

Chongqing, Chongqing Municipality, China

Site Status

The First Affiliated Hospital, Sun-Yat Sen University /ID# 264189

Guangzhou, Guangdong, China

Site Status

The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 265673

Guangzhou, Guangdong, China

Site Status

Nanjing Drum Tower Hospital /ID# 266205

Nanjing, Jiangsu, China

Site Status

Ruijin Hospital /ID# 266869

Shanghai, Shanghai Municipality, China

Site Status

West China Hospital of Sichuan University /ID# 265674

Chengdu, Sichuan, China

Site Status

Sichuan Provincial People's Hospital /ID# 270703

Chengdu, Sichuan, China

Site Status

Jinhua Central Hospital /ID# 265871

Jinhua, Zhejiang, China

Site Status

Fakultní Nemocnice Brno - Jihlavská /ID# 268351

Brno, Brno-mesto, Czechia

Site Status

SurGal Clinic /ID# 268757

Brno, South Moravian, Czechia

Site Status

Nemocnice Ceske Budejovice /ID# 264492

České Budějovice, , Czechia

Site Status

Herlev Hospital /ID# 262487

Herlev, Capital Region, Denmark

Site Status

Hvidovre Hospital /ID# 262613

Hvidovre, Capital Region, Denmark

Site Status

West Tallinn Central Hospital /ID# 270144

Tallinn, Harju, Estonia

Site Status

East Tallinn Central Hospital - Magdaleena Unit /ID# 266653

Tallinn, Harju, Estonia

Site Status

Tartu University Hospital /ID# 270148

Tartu, Tartu, Estonia

Site Status

Chu de Nice-Hopital L'Archet Ii /Id# 261060

Nice, Alpes-Maritimes, France

Site Status

CHU Clermont-Ferrand /ID# 259294

Clermont, Auvergne-Rhône-Alpes, France

Site Status

Hopital Edouard Herriot /ID# 266844

Lyon, Auvergne-Rhône-Alpes, France

Site Status

APHM - Hopital Nord /ID# 259304

Marseille, Bouches-du-Rhone, France

Site Status

Chu Dijon /Id# 265910

Dijon, Bourgogne-Franche-Comté, France

Site Status

Centre Hospitalier Universitaire de Bordeaux /ID# 259298

Pessac, Gironde, France

Site Status

CHU Toulouse - Hopital Rangueil /ID# 258636

Toulouse, Haute-Garonne, France

Site Status

Clinique Beau Soleil /ID# 259289

Montpellier, Herault, France

Site Status

CHU de Montpellier - Hopital Saint Eloi /ID# 269938

Montpellier, Herault, France

Site Status

Ch Chalons En Champagne /Id# 259344

Châlons-en-Champagne, Marne, France

Site Status

CHRU Lille - Hopital Claude Huriez /ID# 259302

Lille, Nord, France

Site Status

Cabinet du docteur Médina Boualit /ID# 259291

Saint-Amand-les-Eaux, Nord, France

Site Status

AP-HP - Hopital Bicetre /ID# 259118

Le Kremlin-Bicêtre, Paris, France

Site Status

CHU de Nantes, Hotel Dieu -HME /ID# 259293

Nantes, Pays de la Loire Region, France

Site Status

Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 259303

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

Site Status

Centre Hospitalier de la Cote Basque /ID# 259297

Bayonne, Pyrenees-Atlantiques, France

Site Status

GH Mutualiste Les Portes Du Sud /ID# 259299

Vénissieux, Rhone, France

Site Status

Hôpital Nord Ouest - Villefranche-sur-Saône /ID# 266999

Villefranche-sur-Saône, Rhone, France

Site Status

CHU Amiens-Picardie Site Sud /ID# 259121

Amiens, Somme, France

Site Status

Pole Sante Saint-Jean /ID# 259296

Cagnes-sur-Mer, , France

Site Status

Centre Hospitalier de CHOLET /ID# 259288

Cholet, , France

Site Status

CH DREUX - Hopital Victor Jousselin /ID# 258635

Dreux, , France

Site Status

AP-HP - Hopital Saint-Antoine /ID# 259116

Paris, , France

Site Status

CHRU Pontchaillou /ID# 259347

Rennes, , France

Site Status

CHU de Strasbourg /ID# 259343

Strasbourg, , France

Site Status

Hopital Beaujon /ID# 259287

Clichy, Île-de-France Region, France

Site Status

Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 259339

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

Site Status

Medizinisches Versorgungszentrum Dachau /ID# 273294

Dachau, Bavaria, Germany

Site Status

Klinikum Lueneburg /ID# 256107

Lüneburg, Lower Saxony, Germany

Site Status

Verein für Wissenschaft und Forschung /ID# 265880

Oldenburg, Lower Saxony, Germany

Site Status

Dres. Kamp & Partner /ID# 267560

Minden, North Rhine-Westphalia, Germany

Site Status

Praxis S. Tetzlaff /ID# 264613

Buedelsdorf, Schleswig-Holstein, Germany

Site Status

Praxis fuer Gastroenterologie /ID# 256106

Lübeck, Schleswig-Holstein, Germany

Site Status

Universitaetsklinikum Jena /ID# 273284

Jena, Thuringia, Germany

Site Status

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 264097

Berlin, , Germany

Site Status

Gastro Studien GbR /ID# 264617

Berlin, , Germany

Site Status

Krankenhaus Waldfriede /ID# 264616

Berlin, , Germany

Site Status

Dr. Janschek /ID# 273218

Dresden, , Germany

Site Status

SKH Studien GmbH /ID# 256100

Hamburg, , Germany

Site Status

Private Practice - Dr. Matthias Eichler /ID# 256105

Hamburg, , Germany

Site Status

Medizinische Hochschule Hannover /ID# 256109

Hanover, , Germany

Site Status

GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 268434

Herne, , Germany

Site Status

Gastropraxis Magdeburg /ID# 266789

Magdeburg, , Germany

Site Status

Praxis Dres Brendel /ID# 256103

Nuremberg, , Germany

Site Status

Praxis Dr. Kempelmann /ID# 256110

Tostedt, , Germany

Site Status

Evangelismos Hospital /ID# 268132

Athens, Attica, Greece

Site Status

General Hospital of Athens G. Gennimatas /ID# 271501

Athens, Attica, Greece

Site Status

General Hospital of Athens Ippokratio /ID# 270248

Athens, Attica, Greece

Site Status

General Hospital of Athens Laiko /ID# 266262

Athens, Attica, Greece

Site Status

University General Hospital of Heraklion /ID# 266260

Heraklion, Crete, Greece

Site Status

University General Hospital of Alexandroupoli /ID# 270161

Alexandroupoli, Evros, Greece

Site Status

Sotiria Thoracic Diseases Hospital of Athens /ID# 264352

Athens, , Greece

Site Status

General Hospital of Athens Alexandra /ID# 266261

Athens, , Greece

Site Status

General State Hospital of Nikaia /ID# 264351

Athens, , Greece

Site Status

Hippokration General Hospital of Thessaloniki /ID# 264353

Thessaloniki, , Greece

Site Status

Debreceni Egyetem-Klinikai Kozpont /ID# 258518

Debrecen, Hajdú-Bihar, Hungary

Site Status

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 258517

Szombathely, Vas County, Hungary

Site Status

Semmelweis Egyetem /ID# 258515

Budapest, , Hungary

Site Status

Eszak-Pesti Centrumkorhaz - Honvedkorhaz /ID# 267156

Budapest, , Hungary

Site Status

Szegedi Tudományegyetem /ID# 258514

Szeged, , Hungary

Site Status

Portiuncula University Hospital /ID# 268856

Ballinasloe, Galway, Ireland

Site Status

St. Vincent's University Hospital /ID# 265638

Dublin, , Ireland

Site Status

Connolly Hospital /ID# 266388

Dublin, , Ireland

Site Status

Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 268732

Monserrato, Cagliari, Italy

Site Status

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 269224

San Giovanni Rotondo, Foggia, Italy

Site Status

IRCCS Istituto Clinico Humanitas /ID# 268731

Rozzano, Lombardy, Italy

Site Status

IRCCS Ospedale San Raffaele /ID# 268426

Milan, Milano, Italy

Site Status

Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 269589

Monza, Monza E Brianza, Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 268759

Rome, Roma, Italy

Site Status

A.O. Ordine Mauriziano di Torino /ID# 269231

Turin, Torino, Italy

Site Status

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 275093

Palermo, , Italy

Site Status

Nagoya University Hospital /ID# 266092

Nagoya, Aichi-ken, Japan

Site Status

Fujita Health University Hospital /ID# 266091

Toyoake, Aichi-ken, Japan

Site Status

Hirosaki University Hospital /ID# 266065

Hirosaki, Aomori, Japan

Site Status

Chiba University Hospital /ID# 266080

Chiba, Chiba, Japan

Site Status

Toho University Sakura Medical Center /ID# 266079

Sakura, Chiba, Japan

Site Status

Kyushu University Hospital /ID# 266100

Fukuoka, Fukuoka, Japan

Site Status

Fukushima Medical University Hospital /ID# 266071

Fukushima, Fukushima, Japan

Site Status

Asahikawa Medical University Hospital /ID# 266062

Asahikawa-shi, Hokkaido, Japan

Site Status

Asahikawa Medical University Hospital /ID# 269111

Asahikawa-shi, Hokkaido, Japan

Site Status

Sapporo Medical University Hospital /ID# 265042

Sapporo, Hokkaido, Japan

Site Status

Hokkaido University Hospital /ID# 266063

Sapporo, Hokkaido, Japan

Site Status

Hyogo Medical University Hospital /ID# 266097

Nishinomiya, Hyōgo, Japan

Site Status

University of Tsukuba Hospital /ID# 266075

Tsukuba, Ibaraki, Japan

Site Status

Iwate Medical University - Yahaba Campus /ID# 266067

Hizume, Iwate, Japan

Site Status

Yokohama City University Medical Center /ID# 266087

Yokohama, Kanagawa, Japan

Site Status

University Hospital Kyoto Prefectural University of Medicine /ID# 268258

Kyoto, Kyoto, Japan

Site Status

Kansai Medical University Hospital /ID# 266095

Hirakata-shi, Osaka, Japan

Site Status

Saga University Hospital /ID# 267884

Saga, Saga-ken, Japan

Site Status

Saitama Medical Center /ID# 266078

Kawagoe, Saitama, Japan

Site Status

Shiga University of Medical Science /ID# 266094

Ōtsu, Shiga, Japan

Site Status

Hamamatsu University Hospital /ID# 266090

Hamamatsu, Shizuoka, Japan

Site Status

Jichi Medical University Hospital /ID# 266077

Shimotsuke-shi, Tochigi, Japan

Site Status

Tokyo Medical And Dental University Hospital /ID# 266081

Bunkyo-ku, Tokyo, Japan

Site Status

Kitasato University Kitasato Institute Hospital /ID# 266084

Minato-ku, Tokyo, Japan

Site Status

Kyorin University Hospital /ID# 266086

Mitaka-shi, Tokyo, Japan

Site Status

Keio University Hospital /ID# 266085

Shinjuku-ku, Tokyo, Japan

Site Status

Fukuoka University Hospital /ID# 266099

Fukuoka, , Japan

Site Status

Hiroshima University Hospital /ID# 266098

Hiroshima, , Japan

Site Status

Osaka Police Hospital /ID# 266096

Osaka, , Japan

Site Status

Sapporo Kosei General Hospital /ID# 266069

Sapporo, , Japan

Site Status

The Jikei University School of Medicine /ID# 266083

Tokyo, , Japan

Site Status

Tokyo Yamate Medical Center /ID# 266082

Tokyo, , Japan

Site Status

Toyama University Hospital /ID# 266089

Toyama, , Japan

Site Status

Toyama Prefectural Central Hospital /ID# 266088

Toyama, , Japan

Site Status

Radboudumc /ID# 264659

Nijmegen, Gelderland, Netherlands

Site Status

Elisabeth TweeSteden Ziekenhuis /ID# 265898

Tilburg, North Brabant, Netherlands

Site Status

OLVG - Locatie Oost /ID# 267099

Amsterdam, North Holland, Netherlands

Site Status

Amsterdam UMC, locatie AMC /ID# 253970

Amsterdam, North Holland, Netherlands

Site Status

Fundeni Clinical Institute /ID# 260354

Bucharest, București, Romania

Site Status

Fundeni Clinical Institute /ID# 260356

Bucharest, București, Romania

Site Status

Fundeni Clinical Institute /ID# 264021

Bucharest, București, Romania

Site Status

Spitalul Universitar de Urgență București /ID# 263763

Bucharest, București, Romania

Site Status

Spitalul Universitar de Urgență București /ID# 264025

Bucharest, București, Romania

Site Status

Spitalul Clinic Judetean de Urgenta Craiova /Id# 264023

Craiova, Dolj, Romania

Site Status

Spitalul Clinic Colentina /ID# 260355

Bucharest, , Romania

Site Status

Gastromond /ID# 263770

Constanța, , Romania

Site Status

Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264022

Iași, , Romania

Site Status

Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264024

Iași, , Romania

Site Status

Cabinet Particular Policlinic Algomed /ID# 260353

Timișoara, , Romania

Site Status

Hospital de Sant Joan Despí Moisès Broggi /ID# 263936

Sant Joan Despí, Barcelona, Spain

Site Status

Hospital Jerez De La Frontera /ID# 273598

Jerez de la Frontera, Cadiz, Spain

Site Status

Hospital Universitario Reina Sofia /ID# 263461

Córdoba, Cordoba, Spain

Site Status

Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263462

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Universitario Severo Ochoa /ID# 263933

Leganés, Madrid, Spain

Site Status

Hospital Universitario Central de Asturias /ID# 263457

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Galdakao-Usansolo /ID# 263458

Galdakao, Vizcaya, Spain

Site Status

Hospital Universitari Vall d'Hebron /ID# 263463

Barcelona, , Spain

Site Status

Hospital Universitario Virgen de las Nieves /ID# 264206

Granada, , Spain

Site Status

Hospital Universitario de La Princesa /ID# 263464

Madrid, , Spain

Site Status

Hospital General Universitario Reina Sofía /ID# 264205

Murcia, , Spain

Site Status

Hospital Alvaro Cunqueiro /ID# 263460

Pontevedra, , Spain

Site Status

Countries

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Australia Bulgaria Canada China Czechia Denmark Estonia France Germany Greece Hungary Ireland Italy Japan Netherlands Romania Spain

Related Links

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Other Identifiers

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P23-899

Identifier Type: -

Identifier Source: org_study_id

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