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

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two first-line biologic treatments, Infliximab (IFX) and Vedolizumab (VDZ), for patients with moderate to severe ulcerative colitis (UC). The main goal is to see which of these treatments is more effective and to understand the factors that influence their success. Researchers will closely monitor patients receiving these treatments to track changes in their condition over time.

To participate in the trial, individuals must be between 18 and 70 years old and have a confirmed diagnosis of moderate to severe UC. They should not have certain other health issues, like severe liver or kidney problems, or be currently pregnant or breastfeeding. Participants can expect regular follow-ups to assess their health and the effectiveness of the treatments. It's important to note that this study has not started recruiting participants yet, so there will be more information available once it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.