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Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)
Ulcerative 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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Gedyt /ID# 249611
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Britanico de Buenos Aires /ID# 249605
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612
Córdoba, Argentina
Blacktown Hospital /ID# 248354
Blacktown, New South Wales, Australia
Nepean Hospital /ID# 248351
Kingswood, New South Wales, Australia
Coral Sea Clinical Research institute /ID# 248352
North Mackay, Queensland, Australia
Austin Health /ID# 249133
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital /ID# 248353
Parkville, Victoria, Australia
University of Calgary /ID# 259183
Calgary, Alberta, Canada
Gastroenterology and Internal Medicine Research Institution /ID# 251463
Edmonton, Alberta, Canada
Start Date
August 15, 2022
Primary Completion Date
March 1, 2028
Completion Date
March 1, 2028
Last Updated
February 28, 2025
785
ACTUAL participants
Lead Sponsor
AbbVie
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009