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Active (not recruiting) NCT05494606

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

Conditions: Ulcerative Colitis

Sponsor: AbbVie

trial.available_in: БГ
Overview
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.
Who can participate
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).
Locations 17
Argentina (1)
Gedyt /ID# 249611
Ciudad Autonoma de Buenos Aire , Buenos Aires F.D.
Australia (1)
Blacktown Hospital /ID# 248354
Blacktown , New South Wales
Canada (1)
University of Calgary /ID# 259183
Calgary , Alberta
Czech Republic (1)
Iscare Klinické Centrum /ID# 259811
Prague , Praha 9
France (1)
Chu de Nice-Hopital L'Archet Ii /Id# 251938
Nice , Alpes-Maritimes
Germany (1)
Medizinisches Versorgunszentrum Dachau /ID# 257231
Dachau , Bavaria
Greece (1)
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 260787
Athens , Attica
Ireland (1)
Connolly Hospital Blanchardstown /ID# 252190
Abbotstown , Dublin
Israel (1)
Shamir Medical Center /ID# 256885
Beer Ya'akov , Central District
Italy (1)
Ente Ospedaliero Specializzato in Gastroenterologia Saverio de Bellis - IRCCS /ID# 261600
Castellana Grotte , Bari
Kuwait (1)
Mubarak Hospital /ID# 252026
Hawalli
Portugal (1)
Hospital Central da Madeira, Hospital Dr. Nélio Mendonça /ID# 271710
Funchal , Madeira
Qatar (1)
Hamad Medical Corporation /ID# 253823
Zone 51 , Baladiyat ar Rayyan
Russia (1)
Voronezh Regional Clinical Hospital #1 /ID# 249932
Voronezh
Spain (1)
Hospital Universitari de Bellvitge /ID# 263932
L'Hospitalet de Llobregat , Barcelona
United Arab Emirates (1)
Burjeel Day Surgery Center /ID# 252030
Abu Dhabi
United Kingdom (1)
Royal Devon & Exeter Hospital /ID# 252734
Exeter , Devon
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
15.08.2022
Completion date
01.03.2028
Registry ID
NCT05494606
Source
anzctr
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