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

NCT06838845 | Recruiting

• 1 other identifier: P25-085
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Achievement of clinical response per partial adapted Mayo score.

  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.

  At Week 8

Study Arms (1)

Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

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

Guangzhou, Guangdong, 510080, China

RECRUITING

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

Guangzhou, Guangdong, 510655, China

RECRUITING

The Second Affiliated Hospital Of Zhengzhou University /ID# 274754

Zhengzhou, Henan, 450014, China

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Yuting Xie

CONTACT

yuting.xie@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

CN (3)