Actively Recruiting
Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-07-03
400
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age range of 18-70 years old, gender not limited
- Diagnosed with ulcerative colitis excluding radiation enteritis, infectious enteritis, tumor related diseases
- Assessed as moderate to severe ulcerative colitis based on the Mayo score
- No treatments during follow-up that affect biologics efficacy assessment
You will not qualify if you...
- Hemodynamic instability
- Significant liver or kidney injury: bilirubin, ALT, AST over twice normal; eGFR below 60 ml/min or dialysis
- Allergy to infliximab or vedolizumab
- Primary gastrointestinal malignancy
- Serious or uncontrolled underlying diseases (blood, digestive, metabolism, endocrine, lung, heart, nervous, mental systems)
- Pregnancy or breastfeeding, including reproductive needs
- Current infections with hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.
- Unable to cooperate with regular follow-up and lab reviews
- Other conditions judged by investigator as unfit for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xijing Hospital of Digestive Diseases
Shanxi, Xi'an, China, 710032
Actively Recruiting
Research Team
D
Dongdong He
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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