An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice
Ulcerative ColitisUlcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.
Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide.
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. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 75
Participation Criteria
Inclusion Criteria:
* Participants with a diagnosis of moderate to severe Ulcerative colitis (UC).
* 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.
* Participants able to understand and communicate with the investigator and comply with the requirements of the study.
* Participants willing to continue with study documentation after cessation of upadacitinib.
* Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).
Exclusion Criteria:
* Participants with any contraindication to upadacitinib.
* Participants previously exposed to upadacitinib in a clinical trial.
* Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).
Study Location
Six08 Gastroenterology /ID# 259452
Six08 Gastroenterology /ID# 259452Lethbridge, Alberta
Canada
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Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819
Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819Hamilton, Ontario
Canada
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Toronto Immune and Digestive Health Institute Inc /ID# 256827
Toronto Immune and Digestive Health Institute Inc /ID# 256827North York, Ontario
Canada
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Diex Recherche Québec Inc. /ID# 262796
Diex Recherche Québec Inc. /ID# 262796Québec, Quebec
Canada
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Dr. J Siffledeen Profess Pract /ID# 256903
Dr. J Siffledeen Profess Pract /ID# 256903Edmonton, Alberta
Canada
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Barrie GI Associates /ID# 264978
Barrie GI Associates /ID# 264978Barrie, Ontario
Canada
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Scott Shulman Medicine Professional Corporation /ID# 256826
Scott Shulman Medicine Professional Corporation /ID# 256826North Bay, Ontario
Canada
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Royal Victoria Hospital / McGill University Health Centre /ID# 258470
Royal Victoria Hospital / McGill University Health Centre /ID# 258470Montreal, Quebec
Canada
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University of Calgary /ID# 259183
University of Calgary /ID# 259183Calgary, Alberta
Canada
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Dr. Sundeep Singh, Inc /ID# 251471
Dr. Sundeep Singh, Inc /ID# 251471Kelowna, British Columbia
Canada
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London Health Sciences Center- University Hospital /ID# 258472
London Health Sciences Center- University Hospital /ID# 258472London, Ontario
Canada
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Toronto Digestive Disease Associates /ID# 258914
Toronto Digestive Disease Associates /ID# 258914Vaughan, Ontario
Canada
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Gastroenterology and Internal Medicine Research Institution /ID# 251463
Gastroenterology and Internal Medicine Research Institution /ID# 251463Edmonton, Alberta
Canada
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The Moncton Hospital /ID# 257337
The Moncton Hospital /ID# 257337Moncton, New Brunswick
Canada
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West GTA Endoscopy /ID# 263221
West GTA Endoscopy /ID# 263221Mississauga, Ontario
Canada
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CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528Montreal, Quebec
Canada
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- Study Sponsored By
- AbbVie
- Participants Required
- More Information
- Study ID:
NCT05494606