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RECRUITING
NCT06962020

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

Sponsor: Xijing Hospital of Digestive Diseases

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2025-04-30

Completion Date

2025-11-20

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DRUG

first-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.

DRUG

first-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