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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib | Participants will receive upadacitinib as prescribed by their physician according to local label |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuting Xie | Contact | yuting.xie@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun-Yat Sen University /ID# 272997 | Recruiting | Guangzhou | Guangdong | 510080 | China | |
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| The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 274753 |
| Recruiting |
| Guangzhou |
| Guangdong |
| 510655 |
| China |
| The Second Affiliated Hospital Of Zhengzhou University /ID# 274754 | Recruiting | Zhengzhou | Henan | 450014 | China |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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