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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib | Participants will receive upadacitinib as prescribed by their physician according to local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with Crohn's disease (CD)
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blacktown Hospital /ID# 258574 | Blacktown | New South Wales | 2148 | Australia | ||
| Macquarie University Hospital /ID# 268722 |
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| Macquarie University |
| New South Wales |
| 2109 |
| Australia |
| Mater Misericordiae Limited /ID# 258535 | South Brisbane | Queensland | 4101 | Australia |
| Ibd Sa /Id# 268335 | Kurralta Park | South Australia | 5037 | Australia |
| The Queen Elizabeth Hospital /ID# 258536 | Woodville South | South Australia | 5011 | Australia |
| Monash Health - Monash Medical Centre /ID# 258538 | Clayton | Victoria | 3168 | Australia |
| The Alfred Hospital /ID# 258537 | Melbourne | Victoria | 3004 | Australia |
| Gastro Med EOOD /ID# 267777 | Pazardzhik | Plovdiv | 4400 | Bulgaria |
| ET dr Nikolay Tsonev /ID# 267584 | Samokov | Sofia | 2000 | Bulgaria |
| MC Higia HB /ID# 267575 | Sofiya | Sofia | 1700 | Bulgaria |
| Umbal Kaspela /ID# 267562 | Plovdiv | 4001 | Bulgaria |
| Diagnostic consultative center Focus-5 /ID# 267576 | Sofia | 1463 | Bulgaria |
| Diagnostic consultative center Focus-5 /ID# 268600 | Sofia | 1463 | Bulgaria |
| AIPSMP dr Mirchev EOOD /ID# 267583 | Varna | 9000 | Bulgaria |
| MC Nadejda Femily EOOD /ID# 267585 | Varna | 9002 | Bulgaria |
| DCC Mladost M /ID# 267586 | Varna | 9009 | Bulgaria |
| Foothills Medical Centre /ID# 263475 | Calgary | Alberta | T2N 2T9 | Canada |
| Dr. J Siffledeen Profess Pract /ID# 262713 | Edmonton | Alberta | T6L 6K3 | Canada |
| Fraser Clinical Trials Inc /ID# 262347 | New Westminster | British Columbia | V3L 3W4 | Canada |
| University of Manitoba & Shared Health /ID# 265853 | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 262764 | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Barrie GI Associates /ID# 268436 | Barrie | Ontario | L4M 7G1 | Canada |
| London Health Sciences Center- University Hospital /ID# 262693 | London | Ontario | N6A 5W9 | Canada |
| West GTA Endoscopy /ID# 262946 | Mississauga | Ontario | L5M 2S4 | Canada |
| Scott Shulman Medicine Professional Corporation /ID# 262060 | North Bay | Ontario | P1B 2H3 | Canada |
| Toronto Immune and Digestive Health Institute Inc /ID# 262540 | North York | Ontario | M6A 3B4 | Canada |
| ABP Research Services Corp. /ID# 263111 | Oakville | Ontario | L6L 5L7 | Canada |
| Toronto Digestive Disease Associates /ID# 262050 | Vaughan | Ontario | L4L 4Y7 | Canada |
| Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 266264 | Montreal | Quebec | H1T 2M4 | Canada |
| Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 262692 | Montreal | Quebec | H4A 3J1 | Canada |
| Diex Recherche Quebec Inc. /ID# 268256 | Québec | G1V 4T3 | Canada |
| Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 265873 | Beijing | Beijing Municipality | 100730 | China |
| Chongqing General Hospital /ID# 268384 | Chongqing | Chongqing Municipality | 400013 | China |
| The First Affiliated Hospital, Sun-Yat Sen University /ID# 264189 | Guangzhou | Guangdong | 510080 | China |
| The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 265673 | Guangzhou | Guangdong | 510655 | China |
| Nanjing Drum Tower Hospital /ID# 266205 | Nanjing | Jiangsu | 210008 | China |
| Ruijin Hospital /ID# 266869 | Shanghai | Shanghai Municipality | 200025 | China |
| West China Hospital of Sichuan University /ID# 265674 | Chengdu | Sichuan | 610041 | China |
| Sichuan Provincial People's Hospital /ID# 270703 | Chengdu | Sichuan | 610072 | China |
| Jinhua Central Hospital /ID# 265871 | Jinhua | Zhejiang | 321000 | China |
| Fakultní Nemocnice Brno - Jihlavská /ID# 268351 | Brno | Brno-mesto | 625 00 | Czechia |
| SurGal Clinic /ID# 268757 | Brno | South Moravian | 602 00 | Czechia |
| Nemocnice Ceske Budejovice /ID# 264492 | České Budějovice | 370 01 | Czechia |
| Herlev Hospital /ID# 262487 | Herlev | Capital Region | 2730 | Denmark |
| Hvidovre Hospital /ID# 262613 | Hvidovre | Capital Region | 2650 | Denmark |
| West Tallinn Central Hospital /ID# 270144 | Tallinn | Harju | 10617 | Estonia |
| East Tallinn Central Hospital - Magdaleena Unit /ID# 266653 | Tallinn | Harju | 11312 | Estonia |
| Tartu University Hospital /ID# 270148 | Tartu | Tartu | 50406 | Estonia |
| Chu de Nice-Hopital L'Archet Ii /Id# 261060 | Nice | Alpes-Maritimes | 06202 | France |
| CHU Clermont-Ferrand /ID# 259294 | Clermont | Auvergne-Rhône-Alpes | 63100 | France |
| Hopital Edouard Herriot /ID# 266844 | Lyon | Auvergne-Rhône-Alpes | 69003 | France |
| APHM - Hopital Nord /ID# 259304 | Marseille | Bouches-du-Rhone | 13015 | France |
| Chu Dijon /Id# 265910 | Dijon | Bourgogne-Franche-Comté | 21000 | France |
| Centre Hospitalier Universitaire de Bordeaux /ID# 259298 | Pessac | Gironde | 33604 | France |
| CHU Toulouse - Hopital Rangueil /ID# 258636 | Toulouse | Haute-Garonne | 31400 | France |
| Clinique Beau Soleil /ID# 259289 | Montpellier | Herault | 34070 | France |
| CHU de Montpellier - Hopital Saint Eloi /ID# 269938 | Montpellier | Herault | 34295 | France |
| Ch Chalons En Champagne /Id# 259344 | Châlons-en-Champagne | Marne | 51000 | France |
| CHRU Lille - Hopital Claude Huriez /ID# 259302 | Lille | Nord | 59037 | France |
| Cabinet du docteur Médina Boualit /ID# 259291 | Saint-Amand-les-Eaux | Nord | 59230 | France |
| AP-HP - Hopital Bicetre /ID# 259118 | Le Kremlin-Bicêtre | Paris | 94270 | France |
| CHU de Nantes, Hotel Dieu -HME /ID# 259293 | Nantes | Pays de la Loire Region | 44000 | France |
| Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 259303 | St-Priest-en-Jarez | Pays de la Loire Region | 42270 | France |
| Centre Hospitalier de la Cote Basque /ID# 259297 | Bayonne | Pyrenees-Atlantiques | 64100 | France |
| GH Mutualiste Les Portes Du Sud /ID# 259299 | Vénissieux | Rhone | 69200 | France |
| Hôpital Nord Ouest - Villefranche-sur-Saône /ID# 266999 | Villefranche-sur-Saône | Rhone | 69655 | France |
| CHU Amiens-Picardie Site Sud /ID# 259121 | Amiens | Somme | 80054 | France |
| Pole Sante Saint-Jean /ID# 259296 | Cagnes-sur-Mer | 06800 | France |
| Centre Hospitalier de CHOLET /ID# 259288 | Cholet | 49300 | France |
| CH DREUX - Hopital Victor Jousselin /ID# 258635 | Dreux | 28102 | France |
| AP-HP - Hopital Saint-Antoine /ID# 259116 | Paris | 75012 | France |
| CHRU Pontchaillou /ID# 259347 | Rennes | 35033 | France |
| CHU de Strasbourg /ID# 259343 | Strasbourg | 67091 | France |
| Hopital Beaujon /ID# 259287 | Clichy | Île-de-France Region | 92110 | France |
| Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 259339 | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
| Medizinisches Versorgungszentrum Dachau /ID# 273294 | Dachau | Bavaria | 85221 | Germany |
| Klinikum Lueneburg /ID# 256107 | Lüneburg | Lower Saxony | 21339 | Germany |
| Verein für Wissenschaft und Forschung /ID# 265880 | Oldenburg | Lower Saxony | 26123 | Germany |
| Dres. Kamp & Partner /ID# 267560 | Minden | North Rhine-Westphalia | 32423 | Germany |
| Praxis S. Tetzlaff /ID# 264613 | Buedelsdorf | Schleswig-Holstein | 24782 | Germany |
| Praxis fuer Gastroenterologie /ID# 256106 | Lübeck | Schleswig-Holstein | 23560 | Germany |
| Universitaetsklinikum Jena /ID# 273284 | Jena | Thuringia | 07743 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 264097 | Berlin | 10117 | Germany |
| Gastro Studien GbR /ID# 264617 | Berlin | 10825 | Germany |
| Krankenhaus Waldfriede /ID# 264616 | Berlin | 14163 | Germany |
| Dr. Janschek /ID# 273218 | Dresden | 01309 | Germany |
| SKH Studien GmbH /ID# 256100 | Hamburg | 20354 | Germany |
| Private Practice - Dr. Matthias Eichler /ID# 256105 | Hamburg | 22041 | Germany |
| Medizinische Hochschule Hannover /ID# 256109 | Hanover | 30625 | Germany |
| GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 268434 | Herne | 44623 | Germany |
| Gastropraxis Magdeburg /ID# 266789 | Magdeburg | 39104 | Germany |
| Praxis Dres Brendel /ID# 256103 | Nuremberg | 90449 | Germany |
| Praxis Dr. Kempelmann /ID# 256110 | Tostedt | 21255 | Germany |
| Evangelismos Hospital /ID# 268132 | Athens | Attica | 10676 | Greece |
| General Hospital of Athens G. Gennimatas /ID# 271501 | Athens | Attica | 11527 | Greece |
| General Hospital of Athens Ippokratio /ID# 270248 | Athens | Attica | 11527 | Greece |
| General Hospital of Athens Laiko /ID# 266262 | Athens | Attica | 11527 | Greece |
| University General Hospital of Heraklion /ID# 266260 | Heraklion | Crete | 71500 | Greece |
| University General Hospital of Alexandroupoli /ID# 270161 | Alexandroupoli | Evros | 68100 | Greece |
| Sotiria Thoracic Diseases Hospital of Athens /ID# 264352 | Athens | 11527 | Greece |
| General Hospital of Athens Alexandra /ID# 266261 | Athens | 11528 | Greece |
| General State Hospital of Nikaia /ID# 264351 | Athens | 14455 | Greece |
| Hippokration General Hospital of Thessaloniki /ID# 264353 | Thessaloniki | 54642 | Greece |
| Debreceni Egyetem-Klinikai Kozpont /ID# 258518 | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 258517 | Szombathely | Vas County | 9700 | Hungary |
| Semmelweis Egyetem /ID# 258515 | Budapest | 1085 | Hungary |
| Eszak-Pesti Centrumkorhaz - Honvedkorhaz /ID# 267156 | Budapest | 1134 | Hungary |
| Szegedi Tudományegyetem /ID# 258514 | Szeged | 6720 | Hungary |
| Portiuncula University Hospital /ID# 268856 | Ballinasloe | Galway | H53 T971 | Ireland |
| St. Vincent's University Hospital /ID# 265638 | Dublin | D04 T6F4 | Ireland |
| Connolly Hospital /ID# 266388 | Dublin | D15 X40D | Ireland |
| Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 268732 | Monserrato | Cagliari | 09042 | Italy |
| Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 269224 | San Giovanni Rotondo | Foggia | 71013 | Italy |
| IRCCS Istituto Clinico Humanitas /ID# 268731 | Rozzano | Lombardy | 20089 | Italy |
| IRCCS Ospedale San Raffaele /ID# 268426 | Milan | Milano | 20132 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 269589 | Monza | Monza E Brianza | 20052 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 268759 | Rome | Roma | 00168 | Italy |
| A.O. Ordine Mauriziano di Torino /ID# 269231 | Turin | Torino | 10128 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 275093 | Palermo | 90127 | Italy |
| Nagoya University Hospital /ID# 266092 | Nagoya | Aichi-ken | 466-8560 | Japan |
| Fujita Health University Hospital /ID# 266091 | Toyoake | Aichi-ken | 470-1192 | Japan |
| Hirosaki University Hospital /ID# 266065 | Hirosaki | Aomori | 036-8563 | Japan |
| Chiba University Hospital /ID# 266080 | Chiba | Chiba | 260-8677 | Japan |
| Toho University Sakura Medical Center /ID# 266079 | Sakura | Chiba | 285-0841 | Japan |
| Kyushu University Hospital /ID# 266100 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Fukushima Medical University Hospital /ID# 266071 | Fukushima | Fukushima | 960-1295 | Japan |
| Asahikawa Medical University Hospital /ID# 266062 | Asahikawa-shi | Hokkaido | 078-8510 | Japan |
| Asahikawa Medical University Hospital /ID# 269111 | Asahikawa-shi | Hokkaido | 078-8510 | Japan |
| Sapporo Medical University Hospital /ID# 265042 | Sapporo | Hokkaido | 060-8543 | Japan |
| Hokkaido University Hospital /ID# 266063 | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Medical University Hospital /ID# 266097 | Nishinomiya | Hyōgo | 663-8501 | Japan |
| University of Tsukuba Hospital /ID# 266075 | Tsukuba | Ibaraki | 305-8576 | Japan |
| Iwate Medical University - Yahaba Campus /ID# 266067 | Hizume | Iwate | 028-3694 | Japan |
| Yokohama City University Medical Center /ID# 266087 | Yokohama | Kanagawa | 232-0024 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 268258 | Kyoto | Kyoto | 602-8566 | Japan |
| Kansai Medical University Hospital /ID# 266095 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Saga University Hospital /ID# 267884 | Saga | Saga-ken | 849-8501 | Japan |
| Saitama Medical Center /ID# 266078 | Kawagoe | Saitama | 350-8550 | Japan |
| Shiga University of Medical Science /ID# 266094 | Ōtsu | Shiga | 520-2192 | Japan |
| Hamamatsu University Hospital /ID# 266090 | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Jichi Medical University Hospital /ID# 266077 | Shimotsuke-shi | Tochigi | 329-0498 | Japan |
| Tokyo Medical And Dental University Hospital /ID# 266081 | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Kitasato University Kitasato Institute Hospital /ID# 266084 | Minato-ku | Tokyo | 108-8642 | Japan |
| Kyorin University Hospital /ID# 266086 | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Keio University Hospital /ID# 266085 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Fukuoka University Hospital /ID# 266099 | Fukuoka | 814-0180 | Japan |
| Hiroshima University Hospital /ID# 266098 | Hiroshima | 734-8551 | Japan |
| Osaka Police Hospital /ID# 266096 | Osaka | 543-0035 | Japan |
| Sapporo Kosei General Hospital /ID# 266069 | Sapporo | 060-0033 | Japan |
| The Jikei University School of Medicine /ID# 266083 | Tokyo | 105-8461 | Japan |
| Tokyo Yamate Medical Center /ID# 266082 | Tokyo | 169-0073 | Japan |
| Toyama University Hospital /ID# 266089 | Toyama | 930-0194 | Japan |
| Toyama Prefectural Central Hospital /ID# 266088 | Toyama | 930-0975 | Japan |
| Radboudumc /ID# 264659 | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Elisabeth TweeSteden Ziekenhuis /ID# 265898 | Tilburg | North Brabant | 5022 GC | Netherlands |
| OLVG - Locatie Oost /ID# 267099 | Amsterdam | North Holland | 1091 AC | Netherlands |
| Amsterdam UMC, locatie AMC /ID# 253970 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Fundeni Clinical Institute /ID# 260354 | Bucharest | Bucharest | 022328 | Romania |
| Fundeni Clinical Institute /ID# 260356 | Bucharest | Bucharest | 022328 | Romania |
| Fundeni Clinical Institute /ID# 264021 | Bucharest | Bucharest | 022328 | Romania |
| Spitalul Universitar de Urgență București /ID# 263763 | Bucharest | Bucharest | 050098 | Romania |
| Spitalul Universitar de Urgență București /ID# 264025 | Bucharest | Bucharest | 050098 | Romania |
| Spitalul Clinic Judetean de Urgenta Craiova /Id# 264023 | Craiova | Dolj | 200642 | Romania |
| Spitalul Clinic Colentina /ID# 260355 | Bucharest | 020121 | Romania |
| Gastromond /ID# 263770 | Constanța | 900635 | Romania |
| Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264022 | Iași | 700111 | Romania |
| Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264024 | Iași | 700111 | Romania |
| Cabinet Particular Policlinic Algomed /ID# 260353 | Timișoara | 300002 | Romania |
| Hospital de Sant Joan Despí Moisès Broggi /ID# 263936 | Sant Joan Despí | Barcelona | 08970 | Spain |
| Hospital Jerez De La Frontera /ID# 273598 | Jerez de la Frontera | Cadiz | 11407 | Spain |
| Hospital Universitario Reina Sofia /ID# 263461 | Córdoba | Cordoba | 14004 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263462 | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Hospital Universitario Severo Ochoa /ID# 263933 | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario Central de Asturias /ID# 263457 | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Galdakao-Usansolo /ID# 263458 | Galdakao | Vizcaya | 48960 | Spain |
| Hospital Universitari Vall d'Hebron /ID# 263463 | Barcelona | 08035 | Spain |
| Hospital Universitario Virgen de las Nieves /ID# 264206 | Granada | 18014 | Spain |
| Hospital Universitario de La Princesa /ID# 263464 | Madrid | 28006 | Spain |
| Hospital General Universitario Reina Sofía /ID# 264205 | Murcia | 30003 | Spain |
| Hospital Alvaro Cunqueiro /ID# 263460 | Pontevedra | 36312 | Spain |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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