First-line biologic choice for moderate-to-severe ulcerative colitis: infliximab versus vedolizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter real-world observational study following adults with moderate-to-severe ulcerative colitis who start either infliximab or vedolizumab as first-line biologic therapy. Investigators will record clinical outcomes using standard measures (including Mayo score), track potential confounders, and compare effectiveness and factors that influence response between the two drugs. Patients with interfering treatments or major organ dysfunction are excluded to reduce bias. The goal is to describe real-world comparative effectiveness and identify characteristics linked to better response for each agent.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xijing Hospital of Digestive Diseases
  Shanxi, Xi'an, China Recruiting

Study contacts

• Study coordinator: Dongdong He
• Email: 929731975@qq.com
• Phone: 0086 + 02984771535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MGT-006 safety and dosing study for ulcerative colitis

  This study tests an oral microbiome capsule called MGT-006 to see if it is safe and tolerable in adults with moderately active ulcerative colitis, and whether the gut bacteria engraft after treatment.

  Recruiting at 9 sites Phase 1/2 Metagen Therapeutics, Inc. · Naples, Florida and 11 other locations · NCT07913347

• PALI-2108 vs placebo for moderate to severe ulcerative colitis

  A phase 2 study to see if PALI-2108 helps people with moderate to severe ulcerative colitis more than a placebo.

  Recruiting at 28 sites Phase 2 Palisade Bio · Sun City, Arizona and 114 other locations · NCT07845487

• Nitazoxanide as an add-on therapy for mild-to-moderate ulcerative colitis

  A study tests whether adding nitazoxanide to standard UC treatment helps people with mild-to-moderate ulcerative colitis see more relief.

  Recruiting at 2 sites Phase 2/3 Tanta University · Tanta and 1 other locations · NCT07820046

• Fecal Transplants from Dai vs Han Donors for Ulcerative Colitis

  This study tests whether fecal microbiota transplantation from healthy Dai donors improves symptoms in adults with ulcerative colitis more than transplantation from healthy Han donors.

  Recruiting Phase 2 First Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07814456

• Familial IBD Early Risk

  This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.

  Recruiting Seattle Children's Hospital · Seattle, Washington · NCT07791862

• Probiotics and Trace Elements Added to Infliximab in Ulcerative Colitis

  This trial tests whether adding a Lactobacillus probiotic or trace elements to infliximab helps people with ulcerative colitis stay in remission.

  Recruiting Phase 4 National Hepatology & Tropical Medicine Research Institute · Cairo · NCT07758335

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.