NCT06962020Recruiting
Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis
Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis: A Prospective, Multi-Center, Real-World Study
Source: ClinicalTrials.gov · Last updated 3 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 30 Apr 2025
- Primary completion date
- 20 Nov 2025
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Ulcerative colitis
- NCT number
- NCT06962020
What you commit to
- Study type: Observational
- Planned participants: 400
- From 30 Apr 2025 to the primary completion date, 20 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.);
Lab values
- 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;
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hospital of Digestive Diseases Coordinator of this site? Confirm its status | Shanxi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.