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.

NCT05930275 | Active Not Recruiting

• 1 other identifier: P23-899
• Study Type: observational
• Target: 1,200
• Locations: 16 countries
• Sites: 168

Brief Summary

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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; CD; Upadacitinib

Outcome Measures

Primary Outcomes (2)

• Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO)

  Daily CR-PRO is a composite endpoint defined as the first day with at least 30% decrease in daily very soft or liquid stool frequency (SF) and/or \>= 30% decrease in daily abdominal pain (AP) score and both not worse than baseline and a prospective 7-day average daily CR-PRO starting on the first day of daily CR-PRO; prospective 7-day average daily CR-PRO is defined as \>= 30% decrease in average daily very soft or liquid SF and/or \>= 30% decrease in average daily AP score and both not worse than baseline.

  Up to Week 12

• Percentage of Participants Achieving Clinical Remission per Harvey Bradshaw Index (HBI) Among those with Clinical Response-Harvey Bradshaw Index (CR-HBI) at End of Induction Therapy

  Clinical Remission is defined as HBI \<= 4. Clinical Response is defined as HBI reduction \>= 3 points from baseline. 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 activity, 8 - 16 indicate moderate disease activity, and 16 indicate severe disease activity.

  At Week 52

Study Arms (1)

Upadacitinib

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Crohn's disease (CD)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (180)

Blacktown Hospital /ID# 258574

Blacktown, New South Wales, 2148, Australia

Location

Macquarie University Hospital /ID# 268722

Macquarie University, New South Wales, 2109, Australia

Location

Mater Misericordiae Limited /ID# 258535

South Brisbane, Queensland, 4101, Australia

Location

Ibd Sa /Id# 268335

Kurralta Park, South Australia, 5037, Australia

Location

The Queen Elizabeth Hospital /ID# 258536

Woodville South, South Australia, 5011, Australia

Location

Monash Health - Monash Medical Centre /ID# 258538

Clayton, Victoria, 3168, Australia

Location

The Alfred Hospital /ID# 258537

Melbourne, Victoria, 3004, Australia

Location

Gastro Med EOOD /ID# 267777

Pazardzhik, Plovdiv, 4400, Bulgaria

Location

ET dr Nikolay Tsonev /ID# 267584

Samokov, Sofia, 2000, Bulgaria

Location

MC Higia HB /ID# 267575

Sofiya, Sofia, 1700, Bulgaria

Location

Umbal Kaspela /ID# 267562

Plovdiv, 4001, Bulgaria

Location

Diagnostic consultative center Focus-5 /ID# 267576

Sofia, 1463, Bulgaria

Location

Diagnostic consultative center Focus-5 /ID# 268600

Sofia, 1463, Bulgaria

Location

AIPSMP dr Mirchev EOOD /ID# 267583

Varna, 9000, Bulgaria

Location

MC Nadejda Femily EOOD /ID# 267585

Varna, 9002, Bulgaria

Location

DCC Mladost M /ID# 267586

Varna, 9009, Bulgaria

Location

Foothills Medical Centre /ID# 263475

Calgary, Alberta, T2N 2T9, Canada

Location

Dr. J Siffledeen Profess Pract /ID# 262713

Edmonton, Alberta, T6L 6K3, Canada

Location

Fraser Clinical Trials Inc /ID# 262347

New Westminster, British Columbia, V3L 3W4, Canada

Location

University of Manitoba & Shared Health /ID# 265853

Winnipeg, Manitoba, R3A 1R9, Canada

Location

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

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Barrie GI Associates /ID# 268436

Barrie, Ontario, L4M 7G1, Canada

Location

London Health Sciences Center- University Hospital /ID# 262693

London, Ontario, N6A 5W9, Canada

Location

West GTA Endoscopy /ID# 262946

Mississauga, Ontario, L5M 2S4, Canada

Location

Scott Shulman Medicine Professional Corporation /ID# 262060

North Bay, Ontario, P1B 2H3, Canada

Location

Toronto Immune and Digestive Health Institute Inc /ID# 262540

North York, Ontario, M6A 3B4, Canada

Location

ABP Research Services Corp. /ID# 263111

Oakville, Ontario, L6L 5L7, Canada

Location

Toronto Digestive Disease Associates /ID# 262050

Vaughan, Ontario, L4L 4Y7, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

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

Montreal, Quebec, H4A 3J1, Canada

Location

Diex Recherche Quebec Inc. /ID# 268256

Québec, G1V 4T3, Canada

Location

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

Beijing, Beijing Municipality, 100730, China

Location

Chongqing General Hospital /ID# 268384

Chongqing, Chongqing Municipality, 400013, China

Location

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

Guangzhou, Guangdong, 510080, China

Location

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

Guangzhou, Guangdong, 510655, China

Location

Nanjing Drum Tower Hospital /ID# 266205

Nanjing, Jiangsu, 210008, China

Location

Ruijin Hospital /ID# 266869

Shanghai, Shanghai Municipality, 200025, China

Location

West China Hospital of Sichuan University /ID# 265674

Chengdu, Sichuan, 610041, China

Location

Sichuan Provincial People's Hospital /ID# 270703

Chengdu, Sichuan, 610072, China

Location

Jinhua Central Hospital /ID# 265871

Jinhua, Zhejiang, 321000, China

Location

Fakultní Nemocnice Brno - Jihlavská /ID# 268351

Brno, Brno-mesto, 625 00, Czechia

Location

SurGal Clinic /ID# 268757

Brno, South Moravian, 602 00, Czechia

Location

Nemocnice Ceske Budejovice /ID# 264492

České Budějovice, 370 01, Czechia

Location

Herlev Hospital /ID# 262487

Herlev, Capital Region, 2730, Denmark

Location

Hvidovre Hospital /ID# 262613

Hvidovre, Capital Region, 2650, Denmark

Location

West Tallinn Central Hospital /ID# 270144

Tallinn, Harju, 10617, Estonia

Location

East Tallinn Central Hospital - Magdaleena Unit /ID# 266653

Tallinn, Harju, 11312, Estonia

Location

Tartu University Hospital /ID# 270148

Tartu, Tartu, 50406, Estonia

Location

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

Nice, Alpes-Maritimes, 06202, France

Location

CHU Clermont-Ferrand /ID# 259294

Clermont, Auvergne-Rhône-Alpes, 63100, France

Location

Hopital Edouard Herriot /ID# 266844

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

APHM - Hopital Nord /ID# 259304

Marseille, Bouches-du-Rhone, 13015, France

Location

Chu Dijon /Id# 265910

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

Centre Hospitalier Universitaire de Bordeaux /ID# 259298

Pessac, Gironde, 33604, France

Location

CHU Toulouse - Hopital Rangueil /ID# 258636

Toulouse, Haute-Garonne, 31400, France

Location

Clinique Beau Soleil /ID# 259289

Montpellier, Herault, 34070, France

Location

CHU de Montpellier - Hopital Saint Eloi /ID# 269938

Montpellier, Herault, 34295, France

Location

Ch Chalons En Champagne /Id# 259344

Châlons-en-Champagne, Marne, 51000, France

Location

CHRU Lille - Hopital Claude Huriez /ID# 259302

Lille, Nord, 59037, France

Location

Cabinet du docteur Médina Boualit /ID# 259291

Saint-Amand-les-Eaux, Nord, 59230, France

Location

AP-HP - Hopital Bicetre /ID# 259118

Le Kremlin-Bicêtre, Paris, 94270, France

Location

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

Nantes, Pays de la Loire Region, 44000, France

Location

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

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

Location

Centre Hospitalier de la Cote Basque /ID# 259297

Bayonne, Pyrenees-Atlantiques, 64100, France

Location

GH Mutualiste Les Portes Du Sud /ID# 259299

Vénissieux, Rhone, 69200, France

Location

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

Villefranche-sur-Saône, Rhone, 69655, France

Location

CHU Amiens-Picardie Site Sud /ID# 259121

Amiens, Somme, 80054, France

Location

Pole Sante Saint-Jean /ID# 259296

Cagnes-sur-Mer, 06800, France

Location

Centre Hospitalier de CHOLET /ID# 259288

Cholet, 49300, France

Location

CH DREUX - Hopital Victor Jousselin /ID# 258635

Dreux, 28102, France

Location

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

Paris, 75012, France

Location

CHRU Pontchaillou /ID# 259347

Rennes, 35033, France

Location

CHU de Strasbourg /ID# 259343

Strasbourg, 67091, France

Location

Hopital Beaujon /ID# 259287

Clichy, Île-de-France Region, 92110, France

Location

Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 259339

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

Location

Medizinisches Versorgungszentrum Dachau /ID# 273294

Dachau, Bavaria, 85221, Germany

Location

Klinikum Lueneburg /ID# 256107

Lüneburg, Lower Saxony, 21339, Germany

Location

Verein für Wissenschaft und Forschung /ID# 265880

Oldenburg, Lower Saxony, 26123, Germany

Location

Dres. Kamp & Partner /ID# 267560

Minden, North Rhine-Westphalia, 32423, Germany

Location

Praxis S. Tetzlaff /ID# 264613

Buedelsdorf, Schleswig-Holstein, 24782, Germany

Location

Praxis fuer Gastroenterologie /ID# 256106

Lübeck, Schleswig-Holstein, 23560, Germany

Location

Universitaetsklinikum Jena /ID# 273284

Jena, Thuringia, 07743, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 264097

Berlin, 10117, Germany

Location

Gastro Studien GbR /ID# 264617

Berlin, 10825, Germany

Location

Krankenhaus Waldfriede /ID# 264616

Berlin, 14163, Germany

Location

Dr. Janschek /ID# 273218

Dresden, 01309, Germany

Location

SKH Studien GmbH /ID# 256100

Hamburg, 20354, Germany

Location

Private Practice - Dr. Matthias Eichler /ID# 256105

Hamburg, 22041, Germany

Location

Medizinische Hochschule Hannover /ID# 256109

Hanover, 30625, Germany

Location

GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 268434

Herne, 44623, Germany

Location

Gastropraxis Magdeburg /ID# 266789

Magdeburg, 39104, Germany

Location

Praxis Dres Brendel /ID# 256103

Nuremberg, 90449, Germany

Location

Praxis Dr. Kempelmann /ID# 256110

Tostedt, 21255, Germany

Location

Evangelismos Hospital /ID# 268132

Athens, Attica, 10676, Greece

Location

General Hospital of Athens G. Gennimatas /ID# 271501

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Ippokratio /ID# 270248

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Laiko /ID# 266262

Athens, Attica, 11527, Greece

Location

University General Hospital of Heraklion /ID# 266260

Heraklion, Crete, 71500, Greece

Location

University General Hospital of Alexandroupoli /ID# 270161

Alexandroupoli, Evros, 68100, Greece

Location

Sotiria Thoracic Diseases Hospital of Athens /ID# 264352

Athens, 11527, Greece

Location

General Hospital of Athens Alexandra /ID# 266261

Athens, 11528, Greece

Location

General State Hospital of Nikaia /ID# 264351

Athens, 14455, Greece

Location

Hippokration General Hospital of Thessaloniki /ID# 264353

Thessaloniki, 54642, Greece

Location

Debreceni Egyetem-Klinikai Kozpont /ID# 258518

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 258517

Szombathely, Vas County, 9700, Hungary

Location

Semmelweis Egyetem /ID# 258515

Budapest, 1085, Hungary

Location

Eszak-Pesti Centrumkorhaz - Honvedkorhaz /ID# 267156

Budapest, 1134, Hungary

Location

Szegedi Tudományegyetem /ID# 258514

Szeged, 6720, Hungary

Location

Portiuncula University Hospital /ID# 268856

Ballinasloe, Galway, H53 T971, Ireland

Location

St. Vincent's University Hospital /ID# 265638

Dublin, D04 T6F4, Ireland

Location

Connolly Hospital /ID# 266388

Dublin, D15 X40D, Ireland

Location

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

Monserrato, Cagliari, 09042, Italy

Location

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

San Giovanni Rotondo, Foggia, 71013, Italy

Location

IRCCS Istituto Clinico Humanitas /ID# 268731

Rozzano, Lombardy, 20089, Italy

Location

IRCCS Ospedale San Raffaele /ID# 268426

Milan, Milano, 20132, Italy

Location

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

Monza, Monza E Brianza, 20052, Italy

Location

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

Rome, Roma, 00168, Italy

Location

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

Turin, Torino, 10128, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 275093

Palermo, 90127, Italy

Location

Nagoya University Hospital /ID# 266092

Nagoya, Aichi-ken, 466-8560, Japan

Location

Fujita Health University Hospital /ID# 266091

Toyoake, Aichi-ken, 470-1192, Japan

Location

Hirosaki University Hospital /ID# 266065

Hirosaki, Aomori, 036-8563, Japan

Location

Chiba University Hospital /ID# 266080

Chiba, Chiba, 260-8677, Japan

Location

Toho University Sakura Medical Center /ID# 266079

Sakura, Chiba, 285-0841, Japan

Location

Kyushu University Hospital /ID# 266100

Fukuoka, Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital /ID# 266071

Fukushima, Fukushima, 960-1295, Japan

Location

Asahikawa Medical University Hospital /ID# 266062

Asahikawa-shi, Hokkaido, 078-8510, Japan

Location

Asahikawa Medical University Hospital /ID# 269111

Asahikawa-shi, Hokkaido, 078-8510, Japan

Location

Sapporo Medical University Hospital /ID# 265042

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital /ID# 266063

Sapporo, Hokkaido, 060-8648, Japan

Location

Hyogo Medical University Hospital /ID# 266097

Nishinomiya, Hyōgo, 663-8501, Japan

Location

University of Tsukuba Hospital /ID# 266075

Tsukuba, Ibaraki, 305-8576, Japan

Location

Iwate Medical University - Yahaba Campus /ID# 266067

Hizume, Iwate, 028-3694, Japan

Location

Yokohama City University Medical Center /ID# 266087

Yokohama, Kanagawa, 232-0024, Japan

Location

University Hospital Kyoto Prefectural University of Medicine /ID# 268258

Kyoto, Kyoto, 602-8566, Japan

Location

Kansai Medical University Hospital /ID# 266095

Hirakata-shi, Osaka, 573-1191, Japan

Location

Saga University Hospital /ID# 267884

Saga, Saga-ken, 849-8501, Japan

Location

Saitama Medical Center /ID# 266078

Kawagoe, Saitama, 350-8550, Japan

Location

Shiga University of Medical Science /ID# 266094

Ōtsu, Shiga, 520-2192, Japan

Location

Hamamatsu University Hospital /ID# 266090

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Jichi Medical University Hospital /ID# 266077

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Tokyo Medical And Dental University Hospital /ID# 266081

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Kitasato University Kitasato Institute Hospital /ID# 266084

Minato-ku, Tokyo, 108-8642, Japan

Location

Kyorin University Hospital /ID# 266086

Mitaka-shi, Tokyo, 181-8611, Japan

Location

Keio University Hospital /ID# 266085

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Fukuoka University Hospital /ID# 266099

Fukuoka, 814-0180, Japan

Location

Hiroshima University Hospital /ID# 266098

Hiroshima, 734-8551, Japan

Location

Osaka Police Hospital /ID# 266096

Osaka, 543-0035, Japan

Location

Sapporo Kosei General Hospital /ID# 266069

Sapporo, 060-0033, Japan

Location

The Jikei University School of Medicine /ID# 266083

Tokyo, 105-8461, Japan

Location

Tokyo Yamate Medical Center /ID# 266082

Tokyo, 169-0073, Japan

Location

Toyama University Hospital /ID# 266089

Toyama, 930-0194, Japan

Location

Toyama Prefectural Central Hospital /ID# 266088

Toyama, 930-0975, Japan

Location

Radboudumc /ID# 264659

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Elisabeth TweeSteden Ziekenhuis /ID# 265898

Tilburg, North Brabant, 5022 GC, Netherlands

Location

OLVG - Locatie Oost /ID# 267099

Amsterdam, North Holland, 1091 AC, Netherlands

Location

Amsterdam UMC, locatie AMC /ID# 253970

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Fundeni Clinical Institute /ID# 260354

Bucharest, București, 022328, Romania

Location

Fundeni Clinical Institute /ID# 260356

Bucharest, București, 022328, Romania

Location

Fundeni Clinical Institute /ID# 264021

Bucharest, București, 022328, Romania

Location

Spitalul Universitar de Urgență București /ID# 263763

Bucharest, București, 050098, Romania

Location

Spitalul Universitar de Urgență București /ID# 264025

Bucharest, București, 050098, Romania

Location

Spitalul Clinic Judetean de Urgenta Craiova /Id# 264023

Craiova, Dolj, 200642, Romania

Location

Spitalul Clinic Colentina /ID# 260355

Bucharest, 020121, Romania

Location

Gastromond /ID# 263770

Constanța, 900635, Romania

Location

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

Iași, 700111, Romania

Location

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

Iași, 700111, Romania

Location

Cabinet Particular Policlinic Algomed /ID# 260353

Timișoara, 300002, Romania

Location

Hospital de Sant Joan Despí Moisès Broggi /ID# 263936

Sant Joan Despí, Barcelona, 08970, Spain

Location

Hospital Jerez De La Frontera /ID# 273598

Jerez de la Frontera, Cadiz, 11407, Spain

Location

Hospital Universitario Reina Sofia /ID# 263461

Córdoba, Cordoba, 14004, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263462

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Hospital Universitario Severo Ochoa /ID# 263933

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Central de Asturias /ID# 263457

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Galdakao-Usansolo /ID# 263458

Galdakao, Vizcaya, 48960, Spain

Location

Hospital Universitari Vall d'Hebron /ID# 263463

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 264206

Granada, 18014, Spain

Location

Hospital Universitario de La Princesa /ID# 263464

Madrid, 28006, Spain

Location

Hospital General Universitario Reina Sofía /ID# 264205

Murcia, 30003, Spain

Location

Hospital Alvaro Cunqueiro /ID# 263460

Pontevedra, 36312, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 5, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CZ (3); HU (5); BU (9); FR (27); GR (10); AU (7); ES (3); DK (2); CN (9); NL (4); DE (18); CA (15); RO (11); IE (3); IT (8); JP (34)