Clinical trial NCT05930275: 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.
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn's Disease
Keywords: Crohn's disease
CD
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with Crohn's disease (CD)

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.


Eligibility criteria: 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.

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