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.
Crohn's DiseaseCrohn'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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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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.
Lieu de l'étude
Dr. J Siffledeen Profess Pract /ID# 262713
Dr. J Siffledeen Profess Pract /ID# 262713Edmonton, Alberta
Canada
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Barrie GI Associates /ID# 268436
Barrie GI Associates /ID# 268436Barrie, Ontario
Canada
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Toronto Immune and Digestive Health Institute Inc /ID# 262540
Toronto Immune and Digestive Health Institute Inc /ID# 262540North York, Ontario
Canada
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Royal Victoria Hospital / McGill University Health Centre /ID# 262692
Royal Victoria Hospital / McGill University Health Centre /ID# 262692Montreal, Quebec
Canada
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Foothills Medical Centre /ID# 263475
Foothills Medical Centre /ID# 263475Calgary, Alberta
Canada
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QEII - Health Sciences Centre /ID# 262764
QEII - Health Sciences Centre /ID# 262764Halifax, Nova Scotia
Canada
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Scott Shulman Medicine Professional Corporation /ID# 262060
Scott Shulman Medicine Professional Corporation /ID# 262060North Bay, Ontario
Canada
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Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 266264
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 266264Montreal, Quebec
Canada
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Fraser Clinical Trials Inc /ID# 262347
Fraser Clinical Trials Inc /ID# 262347New Westminster, British Columbia
Canada
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London Health Sciences Center- University Hospital /ID# 262693
London Health Sciences Center- University Hospital /ID# 262693London, Ontario
Canada
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ABP Research Services Corp. /ID# 263111
ABP Research Services Corp. /ID# 263111Oakville, Ontario
Canada
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Diex Recherche Quebec Inc. /ID# 268256
Diex Recherche Quebec Inc. /ID# 268256Québec, Quebec
Canada
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University of Manitoba & Shared Health /ID# 265853
University of Manitoba & Shared Health /ID# 265853Winnipeg, Manitoba
Canada
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West GTA Endoscopy /ID# 262946
West GTA Endoscopy /ID# 262946Mississauga, Ontario
Canada
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Toronto Digestive Disease Associates /ID# 262050
Toronto Digestive Disease Associates /ID# 262050Vaughan, Ontario
Canada
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- Étude parrainée par
- AbbVie
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05930275