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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: first-line biologic：IFX; Drug: first-line biologic:VDZ

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Dongdong He; Phone Number: 0086 + 02984771535; Email: 929731975@qq.com

Study Locations

• China
  • Xi'an
    • ShanXi, Xi'an, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Diseases
      • Contact: Yongquan Shi; Phone Number: 0086 + 02984771535; Email: shiyquan@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe UC patients treated with biological agents in the Xijing Hospital of Digestive Diseases

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The IFX group; The first-line use of IFX group regularly uses IFX treatment for 3 cycles before continuing to use IFX or adjusting to VDZ treatment.	Drug: 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.
The VDZ group; The first-line use of VDZ group regularly uses VDZ treatment for 3 cycles before continuing to use VDZ or adjusting to IFX treatment.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rates and endoscopic remission rates at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment	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	From enrollment to the end of treatment at 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response rate, endoscopic response rate, and hormone free response rate at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment	Evaluate the clinical response rate, endoscopic response rate, and hormone free response rate at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologic therapy based on the Mayo scoring system and endoscopic examination results	From enrollment to the end of treatment at 2 years.
Factors affecting the efficacy of two biological agents in the treatment process	After balancing confounding factors through PSM, IPTW, and other methods, the factors affecting the efficacy of biologics were analyzed through survival analysis curves	From enrollment to the end of treatment at 2 years.

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Study Director: Min Chen, Xijing Hospital of Digestive Diseases

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): November 20, 2025
• Study Completion (Estimated): November 20, 2025

Study Registration Dates

• First Submitted: April 29, 2025
• First Submitted That Met QC Criteria: April 29, 2025
• First Posted (Actual): May 8, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: ulcerative colitis; biologics
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer
• Other Study ID Numbers: KY20232425-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No