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Clinical Trials in China / NCT06962020
Recruiting Observational

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

NCT06962020 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital of Digestive Diseases
Phase
Observational
Started
2025-04-30
Last updated
2025-07-03

Condition(s) studied

Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

first-line biologic：IFXfirst-line biologic:VDZ

first-line biologic：IFX: IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment.

first-line biologic:VDZ: IFX is administered intravenously at a dose of 5-10mg/kg, once at weeks 0, 2, and 6 (or 0, 1, and 5), and then every 8 weeks at a dose of 5mg/kg for maintenance treatment. VDZ is administered intravenously at a dose of 300mg/time, once at weeks 0, 2, and 6, and then every 8 weeks at a dose of 300mg for maintenance treatment.

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Clinical remission rates and endoscopic remission rates at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment — From enrollment to the end of treatment at 2 years.
    Evaluate the clinical remission rate and endoscopic remission rate of first-line biologics treatment at 14 weeks, 30 weeks, 52 weeks, and 2 years based on the Mayo scoring system and endoscopic examination results

Trial sites (1)

FacilityCityRegionStatus
Xijing Hospital of Digestive Diseases Shanxi Xi'an Recruiting

More Xijing Hospital of Digestive Diseases trials in China

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study Recruiting
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE） Recruiting
Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation Recruiting
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC) Active, not recruiting
Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction Recruiting

Other trials for the same condition

The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC Recruiting
A Study for HSK47388 in Participants With Ulcerative Colitis Recruiting
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis Recruiting
Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics Recruiting
Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06962020 on ClinicalTrials.gov ↗ ← All trials in China