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.
- Conditions
- Crohn's Disease
- Registration Number
- NCT05930275
- 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 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO) Up to Week 12 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.
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 At Week 52 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (177)
MC Nadejda Femily EOOD /ID# 267585
🇧🇬Varna, Bulgaria
DCC Mladost M /ID# 267586
🇧🇬Varna, Bulgaria
CHU Amiens-Picardie Site Sud /ID# 259121
🇫🇷Amiens CEDEX 1, Somme, France
Pole Sante Saint-Jean /ID# 259296
🇫🇷Cagnes Sur Mer, France
Centre Hospitalier de CHOLET /ID# 259288
🇫🇷Cholet, France
CH DREUX - Hopital Victor Jousselin /ID# 258635
🇫🇷Dreux, France
AP-HP - Hopital Saint-Antoine /ID# 259116
🇫🇷Paris, France
CHRU Pontchaillou /ID# 259347
🇫🇷Rennes, France
CHU de Strasbourg /ID# 259343
🇫🇷Strasbourg cedex, France
Praxis Dr. Kempelmann /ID# 256110
🇩🇪Tostedt, Germany
Evangelismos Hospital /ID# 268132
🇬🇷Athens, Attiki, Greece
General Hospital of Athens G. Gennimatas /ID# 271501
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Ippokratio /ID# 270248
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Laiko /ID# 266262
🇬🇷Athens, Attiki, Greece
University General Hospital of Alexandroupoli /ID# 270161
🇬🇷Alexandroupoli, Evros, Greece
Kyushu University Hospital /ID# 266100
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 266071
🇯🇵Fukushima-shi, Fukushima, Japan
Asahikawa Medical University Hospital /ID# 269111
🇯🇵Asahikawa City, Hokkaido, Japan
Asahikawa Medical College Hospital /ID# 266062
🇯🇵Asahikawa, Hokkaido, Japan
Hokkaido University Hospital /ID# 266063
🇯🇵Sapporo-shi, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 265042
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital /ID# 266097
🇯🇵Nishinomiya, Hyogo, Japan
University of Tsukuba Hospital /ID# 266075
🇯🇵Tsukuba-shi, Ibaraki, Japan
Iwate Medical University - Yahaba Campus /ID# 266067
🇯🇵Shiwa, Iwate, Japan
Yokohama City University Medical Center /ID# 266087
🇯🇵Yokohama, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 268258
🇯🇵Kyoto-shi, Kyoto, Japan
Kansai Medical University Hospital /ID# 266095
🇯🇵Hirakata-shi, Osaka, Japan
Saga University Hospital /ID# 267884
🇯🇵Saga-shi, Saga, Japan
Saitama Medical Center /ID# 266078
🇯🇵Kawagoe, Saitama, Japan
Shiga University of Medical Science /ID# 266094
🇯🇵Otsu, Shiga, Japan
Hamamatsu University Hospital /ID# 266090
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Jichi Medical University Hospital /ID# 266077
🇯🇵Shimotsuke, Tochigi, Japan
Blacktown Hospital /ID# 258574
🇦🇺Blacktown, New South Wales, Australia
Macquarie University Hospital /ID# 268722
🇦🇺Macquarie University, New South Wales, Australia
Mater Misericordiae Limited /ID# 258535
🇦🇺South Brisbane, Queensland, Australia
Ibd Sa /Id# 268335
🇦🇺Kurralta Park, South Australia, Australia
The Queen Elizabeth Hospital /ID# 258536
🇦🇺Woodville South, South Australia, Australia
Monash Health - Monash Medical Centre /ID# 258538
🇦🇺Clayton, Victoria, Australia
The Alfred Hospital /ID# 258537
🇦🇺Melbourne, Victoria, Australia
Gastro Med EOOD /ID# 267777
🇧🇬Pazardzhik, Plovdiv, Bulgaria
ET dr Nikolay Tsonev /ID# 267584
🇧🇬Samokov, Sofia, Bulgaria
MC Higia HB /ID# 267575
🇧🇬Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 267562
🇧🇬Plovdiv, Bulgaria
Diagnostic consultative center Focus-5 /ID# 267576
🇧🇬Sofiya, Bulgaria
Diagnostic consultative center Focus-5 /ID# 268600
🇧🇬Sofiya, Bulgaria
AIPSMP dr Mirchev EOOD /ID# 267583
🇧🇬Varna, Bulgaria
Foothills Medical Centre /ID# 263475
🇨🇦Calgary, Alberta, Canada
Dr. J Siffledeen Profess Pract /ID# 262713
🇨🇦Edmonton, Alberta, Canada
Fraser Clinical Trials Inc /ID# 262347
🇨🇦New Westminster, British Columbia, Canada
University of Manitoba & Shared Health /ID# 265853
🇨🇦Winnipeg, Manitoba, Canada
QEII - Health Sciences Centre /ID# 262764
🇨🇦Halifax, Nova Scotia, Canada
Barrie GI Associates /ID# 268436
🇨🇦Barrie, Ontario, Canada
London Health Sciences Center- University Hospital /ID# 262693
🇨🇦London, Ontario, Canada
West GTA Endoscopy /ID# 262946
🇨🇦Mississauga, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 262060
🇨🇦North Bay, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc /ID# 262540
🇨🇦North York, Ontario, Canada
ABP Research Services Corp. /ID# 263111
🇨🇦Oakville, Ontario, Canada
Toronto Digestive Disease Associates /ID# 262050
🇨🇦Vaughan, Ontario, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 266264
🇨🇦Montreal, Quebec, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 262692
🇨🇦Montreal, Quebec, Canada
Diex Recherche Quebec Inc. /ID# 268256
🇨🇦Quebec, Canada
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 265873
🇨🇳Beijing, Beijing, China
Chongqing General Hospital /ID# 268384
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital, Sun-Yat Sen University /ID# 264189
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 265673
🇨🇳Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital /ID# 266205
🇨🇳Nanjing, Jiangsu, China
Ruijin Hospital /ID# 266869
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University /ID# 265674
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital /ID# 270703
🇨🇳Chengdu, Sichuan, China
Jinhua Central Hospital /ID# 265871
🇨🇳Jinhua, Zhejiang, China
SurGal Clinic /ID# 268757
🇨🇿Brno, Jihomoravsky Kraj, Czechia
Herlev Hospital /ID# 262487
🇩🇰Herlev, Hovedstaden, Denmark
Hvidovre Hospital /ID# 262613
🇩🇰Hvidovre, Hovedstaden, Denmark
West Tallinn Central Hospital /ID# 270144
🇪🇪Tallinn, Harjumaa, Estonia
East Tallinn Central Hospital - Magdaleena Unit /ID# 266653
🇪🇪Tallinn, Harjumaa, Estonia
Tartu University Hospital /ID# 270148
🇪🇪Tartu, Tartumaa, Estonia
Chu de Nice-Hopital L'Archet Ii /Id# 261060
🇫🇷Nice, Alpes-Maritimes, France
CHU Clermont-Ferrand /ID# 259294
🇫🇷Clermont, Auvergne-Rhone-Alpes, France
Hopital Edouard Herriot /ID# 266844
🇫🇷Lyon, Auvergne-Rhone-Alpes, France
APHM - Hopital Nord /ID# 259304
🇫🇷Marseille, Bouches-du-Rhone, France
Chu Dijon /Id# 265910
🇫🇷Dijon, Bourgogne-Franche-Comte, France
Centre Hospitalier Universitaire de Bordeaux /ID# 259298
🇫🇷Pessac CEDEX, Gironde, France
CHU Toulouse - Hopital Rangueil /ID# 258636
🇫🇷Toulouse, Haute-Garonne, France
Clinique Beau Soleil /ID# 259289
🇫🇷Montpellier, Herault, France
CHU de Montpellier - Hopital Saint Eloi /ID# 269938
🇫🇷Montpellier, Herault, France
Hopital Beaujon /ID# 259287
🇫🇷Clichy, Ile-de-France, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 259339
🇫🇷Neuilly Sur Seine, Ile-de-France, France
Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 259303
🇫🇷St-Priest-en-Jarez, Loire, France
Ch Chalons En Champagne /Id# 259344
🇫🇷Chalons en Champagne, Marne, France
CHRU Lille - Hopital Claude Huriez /ID# 259302
🇫🇷Lille, Nord, France
Cabinet du docteur Médina Boualit /ID# 259291
🇫🇷St Amand les Eaux, Nord, France
AP-HP - Hopital Bicetre /ID# 259118
🇫🇷Le Kremlin Bicetre, Paris, France
CHU de Nantes, Hotel Dieu -HME /ID# 259293
🇫🇷Nantes, Pays-de-la-Loire, France
Centre Hospitalier de la Cote Basque /ID# 259297
🇫🇷Bayonne, Pyrenees-Atlantiques, France
GH Mutualiste Les Portes Du Sud /ID# 259299
🇫🇷Venissieux, Rhone, France
Hôpital Nord Ouest - Villefranche-sur-Saône /ID# 266999
🇫🇷Villefranche Sur Saone CEDEX, Rhone, France
Medizinisches Versorgungszentrum Dachau /ID# 273294
🇩🇪Dachau, Bayern, Germany
Klinikum Lueneburg /ID# 256107
🇩🇪Lueneburg, Niedersachsen, Germany
Verein für Wissenschaft und Forschung /ID# 265880
🇩🇪Oldenburg, Niedersachsen, Germany
Dres. Kamp & Partner /ID# 267560
🇩🇪Minden, Nordrhein-Westfalen, Germany
Praxis S. Tetzlaff /ID# 264613
🇩🇪Büdelsdorf, Schleswig-Holstein, Germany
Praxis fuer Gastroenterologie /ID# 256106
🇩🇪Lübeck, Schleswig-Holstein, Germany
Universitaetsklinikum Jena /ID# 273284
🇩🇪Jena, Thueringen, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 264097
🇩🇪Berlin, Germany
Gastro Studien GbR /ID# 264617
🇩🇪Berlin, Germany
Krankenhaus Waldfriede /ID# 264616
🇩🇪Berlin, Germany
Dr. Janschek /ID# 273218
🇩🇪Dresden, Germany
SKH Studien GmbH /ID# 256100
🇩🇪Hamburg, Germany
Private Practice - Dr. Matthias Eichler /ID# 256105
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover /ID# 256109
🇩🇪Hannover, Germany
GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 268434
🇩🇪Herne, Germany
Gastropraxis Magdeburg /ID# 266789
🇩🇪Magdeburg, Germany
Praxis Dres Brendel /ID# 256103
🇩🇪Nuernberg, Germany
Sotiria Thoracic Diseases Hospital of Athens /ID# 264352
🇬🇷Athens, Greece
General Hospital of Athens Alexandra /ID# 266261
🇬🇷Athens, Greece
General State Hospital of Nikaia /ID# 264351
🇬🇷Athens, Greece
University General Hospital of Heraklion /ID# 266260
🇬🇷Heraklion, Greece
Hippokration General Hospital of Thessaloniki /ID# 264353
🇬🇷Thessaloniki, Greece
Debreceni Egyetem-Klinikai Kozpont /ID# 258518
🇭🇺Debrecen, Hajdu-Bihar, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 258517
🇭🇺Szombathely, Vas, Hungary
Semmelweis Egyetem /ID# 258515
🇭🇺Budapest, Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz /ID# 267156
🇭🇺Budapest, Hungary
Szegedi Tudományegyetem /ID# 258514
🇭🇺Szeged, Hungary
Portiuncula University Hospital /ID# 268856
🇮🇪Ballinasloe, Galway, Ireland
St. Vincent's University Hospital /ID# 265638
🇮🇪Dublin, Ireland
Connolly Hospital /ID# 266388
🇮🇪Dublin, Ireland
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 268732
🇮🇹Monserrato, Cagliari, Italy
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 269224
🇮🇹San Giovanni Rotondo, Foggia, Italy
IRCCS Istituto Clinico Humanitas /ID# 268731
🇮🇹Rozzano, Lombardia, Italy
IRCCS Ospedale San Raffaele /ID# 268426
🇮🇹Milan, Milano, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 269589
🇮🇹Monza, Monza E Brianza, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 268759
🇮🇹Rome, Roma, Italy
A.O. Ordine Mauriziano di Torino /ID# 269231
🇮🇹Turin, Torino, Italy
Nagoya University Hospital /ID# 266092
🇯🇵Nagoya-shi, Aichi, Japan
Fujita Health University Hospital /ID# 266091
🇯🇵Toyoake, Aichi, Japan
Hirosaki University Hospital /ID# 266065
🇯🇵Hirosaki, Aomori, Japan
Chiba University Hospital /ID# 266080
🇯🇵Chiba-shi, Chiba, Japan
Toho University Sakura Medical Center /ID# 266079
🇯🇵Sakura, Chiba, Japan
Tokyo Medical And Dental University Hospital /ID# 266081
🇯🇵Bunkyo-ku, Tokyo, Japan
Kyorin University Hospital /ID# 266086
🇯🇵Mitaka-shi, Tokyo, Japan
Keio University Hospital /ID# 266085
🇯🇵Shinjuku-ku, Tokyo, Japan
Fukuoka University Hospital /ID# 266099
🇯🇵Fukuoka, Japan
Hiroshima University Hospital /ID# 266098
🇯🇵Hiroshima, Japan
Osaka Police Hospital /ID# 266096
🇯🇵Osaka, Japan
Sapporo Kosei General Hospital /ID# 266069
🇯🇵Sapporo, Japan
The Jikei University School of Medicine /ID# 266083
🇯🇵Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 266084
🇯🇵Tokyo, Japan
Tokyo Yamate Medical Center /ID# 266082
🇯🇵Tokyo, Japan
Toyama University Hospital /ID# 266089
🇯🇵Toyama, Japan
Toyama Prefectural Central Hospital /ID# 266088
🇯🇵Toyama, Japan
Radboudumc /ID# 264659
🇳🇱Nijmegen, Gelderland, Netherlands
Elisabeth TweeSteden Ziekenhuis /ID# 265898
🇳🇱Tilburg, Noord-Brabant, Netherlands
OLVG - Locatie Oost /ID# 267099
🇳🇱Amsterdam, Noord-Holland, Netherlands
Amsterdam UMC, locatie AMC /ID# 253970
🇳🇱Amsterdam, Noord-Holland, Netherlands
Fundeni Clinical Institute /ID# 260354
🇷🇴Bucharest, Bucuresti, Romania
Fundeni Clinical Institute /ID# 260356
🇷🇴Bucharest, Bucuresti, Romania
Fundeni Clinical Institute /ID# 264021
🇷🇴Bucharest, Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta Craiova /Id# 264023
🇷🇴Craiova, Dolj, Romania
Spitalul Universitar de Urgență București /ID# 263763
🇷🇴Bucharest, Romania
Spitalul Universitar de Urgență București /ID# 264025
🇷🇴Bucharest, Romania
Spitalul Clinic Colentina /ID# 260355
🇷🇴Bucuresti, Romania
Gastromond /ID# 263770
🇷🇴Constanta, Romania
Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264022
🇷🇴Jassi, Romania
Spitalul Clinic Județean de Urgențe "Sfântul Spiridon" /ID# 264024
🇷🇴Jassi, Romania
Cabinet Particular Policlinic Algomed /ID# 260353
🇷🇴Timișoara, Romania
Hospital Universitario Central de Asturias /ID# 263457
🇪🇸Oviedo, Asturias, Spain
Hospital de Sant Joan Despí Moisès Broggi /ID# 263936
🇪🇸Sant Joan Despí, Barcelona, Spain
Hospital Jerez De La Frontera /ID# 273598
🇪🇸Jerez de la Frontera, Cadiz, Spain
Hospital Universitario Reina Sofia /ID# 263461
🇪🇸Córdoba, Cordoba, Spain
Hospital Universitario de Gran Canaria Doctor Negrín /ID# 263462
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Severo Ochoa /ID# 263933
🇪🇸Leganés, Madrid, Spain
Hospital Galdakao-Usansolo /ID# 263458
🇪🇸Galdakao, Vizcaya, Spain
Hospital Universitari Vall d'Hebron /ID# 263463
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de las Nieves /ID# 264206
🇪🇸Granada, Spain
Hospital Universitario de La Princesa /ID# 263464
🇪🇸Madrid, Spain
Hospital General Universitario Reina Sofía /ID# 264205
🇪🇸Murcia, Spain
Hospital Alvaro Cunqueiro /ID# 263460
🇪🇸Pontevedra, Spain