An Observational Study to Evaluate Effectiveness and Safety of Upadacitinib in Chinese Adult Participants With Moderate to Severely Active Ulcerative Colitis (UC)

Last updated: April 21, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Ulcers

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT06838845
P25-085
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  • Participants prescribed upadacitinib at discretion of their treating physiciansbased 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 dataprior to the entry into the study

Exclusion

Exclusion Criteria:

  • Participant participating in any interventional trials

  • Participant with any contraindication to upadacitinib as listed on the local Chinalabel

  • Participant unwilling or unable to comply with the study requirements, includingcompletion of patient reported outcome questionnaires

Study Design

Total Participants: 80
Study Start date:
April 09, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

  • The Second Affiliated Hospital Of Zhengzhou University /ID# 274754

    Zhengzhou, Henan 450014
    China

    Active - Recruiting

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