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. (UPlift)

July 16, 2025 updated by: AbbVie

A Multi-country, Prospective, Post-marketing Study of UPadacitinib Evaluating Speed of Onset and Durability of Effectiveness for Patients With Moderate to Severe Crohn's Disease for 3 Years in Real-world Clinical Practice (UPlift)

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with Crohn's disease (CD)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Achieve First Clinical Response (CR) per Patient-Reported Outcome 2 (PRO2) (Daily CR-PRO)
Time Frame: 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.
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
Time Frame: 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.
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23-899

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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