Clinical trial NCT06838845: An Observational Study to Evaluate Effectiveness and Safety of Upadacitinib in Chinese Adult Participants With Moderate to Severely Active Ulcerative Colitis (UC)
Official title: Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese adult participants with diagnosis of moderate to severe UC with Tumor Necrosis Factor Inhibitor-Inadequate Responder (TNF-IR) or have contraindications to Tumor Necrosis Factor (TNF) blockers, and commenced on upadacitinib treatment prescribed as part of their routine clinical care at their clinician's discretion according to locally approved label and local treatment prescription recommendations/guidelines.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Achievement of clinical response per partial adapted Mayo score.
timeFrame: At Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753
state: Guangdong
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital Of Zhengzhou University /ID# 274754
state: Henan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: