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

Xijing Hospital of Digestive Diseases

Status

Enrolling

Conditions

Ulcerative Colitis (UC)

Treatments

Drug: first-line biologic：IFX

Drug: first-line biologic:VDZ

Study type

Observational

Funder types

Other

Identifiers

NCT06962020

KY20232425-F-1

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.