RecruitingNCT06962020

Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis

Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis: A Prospective, Multi-Center, Real-World Study


Sponsor

Xijing Hospital of Digestive Diseases

Enrollment

400 participants

Start Date

Apr 30, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this prospective, multicenter, real-world study is to compare the efficacy differences and influencing factors of different first-line biologics in patients with moderate to severe ulcerative colitis. The question that this study aims to answer is: When treating patients with moderate to severe ulcerative colitis, should IFX or VDZ be prioritized as the first-line choice for biologics?, Which biological agent has better therapeutic effect?. Researchers will observe and follow up with patients with moderate to severe ulcerative colitis treated with different biologics on the front line, evaluate their condition changes, eliminate relevant interfering factors, and draw the final conclusion.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the real-world effectiveness of two types of biologic medications — infliximab (IFX) and vedolizumab (VDZ) — as first-line treatments for people with moderate to severe ulcerative colitis (UC), a chronic inflammatory bowel condition. Researchers want to understand which drug works best and for whom. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with ulcerative colitis (not infection-related or cancer-related bowel disease) - Your UC is rated moderate to severe based on a clinical scoring tool called the Mayo score - You will not be using other treatments (medications or surgery) that would interfere with evaluating the biologic drug **You may NOT be eligible if...** - You have unstable blood circulation (hemodynamic instability) - You have significant liver or kidney impairment - You are allergic to infliximab or vedolizumab - You have gastrointestinal cancer - You have active infections (including hepatitis B, hepatitis C, TB, HIV, or syphilis) - You are pregnant or breastfeeding - You cannot attend regular follow-up visits 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

DRUGfirst-line biologic:IFX

IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment.

DRUGfirst-line biologic:VDZ

IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment.


Locations(1)

Xijing Hospital of Digestive Diseases

Shanxi, Xi'an, China

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NCT06962020


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