Clinical trial NCT06962020: Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis
Official title: Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis: A Prospective, Multi-Center, Real-World Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ulcerative Colitis (UC)
Keywords: biologics
ulcerative colitis
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate to severe UC patients treated with biological agents in the Xijing Hospital of Digestive Diseases

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.


Eligibility criteria: 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 outcomes:
measure: Clinical remission rates and endoscopic remission rates at 14 weeks, 30 weeks, 52 weeks, and 2 years after first-line biologics treatment
timeFrame: From enrollment to the end of treatment at 2 years.
Secondary outcomes:
measure: 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
timeFrame: From enrollment to the end of treatment at 2 years.
measure: Factors affecting the efficacy of two biological agents in the treatment process
timeFrame: From enrollment to the end of treatment at 2 years.
Other outcomes:
Locations:
city: ShanXi
country: China
facility: Xijing Hospital of Digestive Diseases
state: Xi'an
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Min Chen
role: STUDY_DIRECTOR
References: