Status:
RECRUITING
Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
18-70 years
Brief 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 ulce...
Eligibility Criteria
Inclusion
- Age range of 18-70 years old, gender not limited;
- According to international guidelines and consensus, patients with ulcerative colitis should be diagnosed to exclude radiation enteritis, infectious enteritis, tumor related diseases, etc;
- Patients assessed as moderate to severe ulcerative colitis based on the Mayo score;
- During the follow-up period, no relevant treatments (drugs and surgery) were used that could affect the assessment of the efficacy of biologics
Exclusion
- Patients with hemodynamic instability;
- Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR\<60ml/min or dialysis patients;
- Patients allergic to IFX or VDZ;
- Patients whose primary disease was gastrointestinal malignancy;
- Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
- Female patients during pregnancy and breastfeeding (including patients with reproductive needs);
- Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.);
- Patients who cannot cooperate with regular follow-up and review of laboratory indicators;
- Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
Key Trial Info
Start Date :
April 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 20 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06962020
Start Date
April 30 2025
End Date
November 20 2025
Last Update
July 3 2025
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases
Shanxi, Xi'an, China, 710032