Compares two first-line biologic medicines for moderate to severe ulcerative colitis
Compares infliximab and vedolizumab in adults with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis
Key facts
- Where
- Shanxi, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06962020, who can take part
Where in China
- Xijing Hospital of Digestive DiseasesShanxi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xijing Hospital of Digestive Diseases
- Trial code
- NCT06962020
- Record updated
- 3 July 2025
- Original description
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.Read full original descriptionShow less
Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis: A Prospective, Multi-Center, Real-World Study
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.
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 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; Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.); 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 who cannot cooperate with regular follow-up and review of laboratory indicators; Patients with hemodynamic instability; Female patients during pregnancy and breastfeeding (including patients with reproductive needs); Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.