Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

Ulcerative colitis (UC) is a chronic, relapsing, and incurable inflammatory disease of the large intestine. The hallmark clinical symptoms include bloody diarrhea associated with rectal urgency and tenesmus.. This study will assess how effective upadacitinib is in treating UC within a Chinese population. Upadacitinib is an approved drug for treating UC. Approximately 80 adult participants, who have been prescribed upadacitinib for UC by their physician in accordance with local label, will be enrolled in China. Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 1 year. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Chinese participants meet the diagnosis of moderately to severely active Ulcerative colitis (UC)

• Participants prescribed upadacitinib at discretion of their treating physicians based on sufficient consideration of benefits/risks for patients per local label

• Participant must be an adult (≥ 18 years)

• Participant must provide written authorization to use personal and/or health data prior to the entry into the study

Locations
Other Locations
China
The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997
RECRUITING
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753
RECRUITING
Guangzhou
The Second Affiliated Hospital Of Zhengzhou University /ID# 274754
RECRUITING
Zhengzhou
Contact Information
Primary
Yuting Xie
yuting.xie@abbvie.com
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2027-03
Participants
Target number of participants: 80
Treatments
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov