Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Recruiting

• Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
• Interventions: Drug: Upadacitinib

• Registration Number: NCT06780683
• Lead Sponsor: Xiang Gao

Brief Summary

Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-05
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.

Exclusion Criteria

• Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's disease	Upadacitinib	-
ulcerative colitis	Upadacitinib	-

Primary Outcome Measures

Name	Time	Method
Clinical Remission Rate	52 weeks	Clinical remission rate in patients with ulcerative Colitis or Crohn's Disease.

Trial Locations

Locations (6)

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

The Eighth Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Shenzhen, Guangdong, China

Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Liuzhou People's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine; 🇨🇳 Nanning, Guangxi, China

Meizhou People's Hospital; 🇨🇳 Meizhou, Guangdong, China