An Observational Study to Evaluate Effectiveness and Safety of Upadacitinib in Chinese Adult Participants With Moderate to Severely Active Ulcerative Colitis (UC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Observational Study Of Upadacitinib in Ulcerative Colitis in China
Overview
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.
Primary outcome measures
- Achievement of clinical response per partial adapted Mayo score. [Time frame: At Week 8]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997 — Guangzhou
- The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753 — Guangzhou
- The Second Affiliated Hospital Of Zhengzhou University /ID# 274754 — Zhengzhou
Identifiers
NCT: NCT06838845 · P25-085