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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorXijing Hospital of Digestive Diseases

About this trial

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

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • first-line biologic:IFX
  • first-line biologic:VDZ

Treatment groups

400 Participants
are divided into 2 treatment groups