RecruitingNCT06780683

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study


Sponsor

Xiang Gao

Enrollment

174 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on patients with inflammatory bowel disease — either ulcerative colitis or Crohn's disease — who are starting treatment with a medication called upadacitinib (a JAK inhibitor). Researchers want to track how well the drug works and what side effects occur in everyday clinical practice, outside of a controlled trial setting. **You may be eligible if...** - You have been diagnosed with ulcerative colitis or Crohn's disease based on current medical guidelines - Your doctor has decided that upadacitinib is the appropriate first treatment with this drug for your condition - You are able and willing to provide signed informed consent - You are of any gender **You may NOT be eligible if...** - You are currently participating in another clinical trial - You have a medical reason that makes upadacitinib unsafe for you (as per the drug's prescribing information) - Your treating doctor has assessed you as unsuitable for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUpadacitinib

Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease). Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.


Locations(6)

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

The Eighth Affiliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine

Nanning, Guangxi, China

View Full Details on ClinicalTrials.gov

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NCT06780683


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