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

Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06838845

Enrollment

Registered

2025-02-21

Start date

2025-04-09

Completion date

2026-12-31

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Participant participating in any interventional trials * Participant with any contraindication to upadacitinib as listed on the local China label * Participant unwilling or unable to comply with the study requirements, including completion of patient reported outcome questionnaires

Design outcomes

Primary

Measure	Time frame	Description
Achievement of clinical response per partial adapted Mayo score.	At Week 8	Defined as a decrease in Partial Adapted Mayo score of ≥ 1 point and a decrease of ≥ 30% from Baseline, PLUS either a decrease in rectal bleeding sub-score (RBS) of ≥ 1 point or an absolute RBS of ≤ 1.

Countries

China

Contacts

Primary ContactYuting Xie

yuting.xie@abbvie.com

Outcome results