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

NCT06962020 | Recruiting

• 1 other identifier: KY20232425-F-1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis (UC)

Keywords

biologics; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  From enrollment to the end of treatment at 2 years.

• Factors affecting the efficacy of two biological agents in the treatment process

  From enrollment to the end of treatment at 2 years.

Study Arms (2)

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

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

Interventions

first-line biologic：IFX DRUG

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 IFX group

first-line biologic:VDZ DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Shanxi, Xi'an, 710032, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Min Chen

  Xijing Hospital of Digestive Diseases

  STUDY DIRECTOR

Central Study Contacts

Dongdong He

CONTACT

0086 + 02984771535; 929731975@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: April 30, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)