First-line biologic choice for moderate-to-severe ulcerative colitis: infliximab versus vedolizumab

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

This will test whether infliximab or vedolizumab works better as the first biologic for adults aged 18–70 with moderate-to-severe ulcerative colitis.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanxi, Xi'an)
• Trial ID: NCT06962020 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter real-world observational study following adults with moderate-to-severe ulcerative colitis who start either infliximab or vedolizumab as first-line biologic therapy. Investigators will record clinical outcomes using standard measures (including Mayo score), track potential confounders, and compare effectiveness and factors that influence response between the two drugs. Patients with interfering treatments or major organ dysfunction are excluded to reduce bias. The goal is to describe real-world comparative effectiveness and identify characteristics linked to better response for each agent.

Who should consider this trial

Good fit: Adults 18–70 years old with a confirmed diagnosis of moderate-to-severe ulcerative colitis by Mayo score, without concurrent treatments that would affect biologic efficacy and with adequate liver and kidney function are ideal candidates.

Not a fit: Patients with hemodynamic instability, significant liver or kidney injury, known allergy to infliximab or vedolizumab, active gastrointestinal malignancy, or other uncontrolled serious systemic diseases are unlikely to be eligible or benefit from participation.

Why it matters

Potential benefit: If successful, the results could help doctors choose the biologic that is more likely to control symptoms and improve outcomes for similar patients.

How similar studies have performed: Head-to-head randomized comparisons are limited, though observational studies and indirect comparisons suggest infliximab often produces faster response while vedolizumab may have a different safety and long-term effectiveness profile.

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.

Where this trial is running

Shanxi, Xi'an

• Xijing Hospital of Digestive Diseases — Shanxi, Xi'an, China (Recruiting)

Study contacts

• Study coordinator: Dongdong He

Conditions Ulcerative Colitis; biologics; ulcerative colitis