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Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

NCT05205603 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2026-04-29

No results posted yet for this study

Summary

Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.

Conditions

Interventions

DRUG

Infliximab

Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks

DRUG

Vedolizumab

Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks

DRUG

Mesalazine

Mesalazine, 4-6g/d, systemic and/or topical administration

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-15
Primary Completion
2024-01-15
Completion
2025-01-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205603 on ClinicalTrials.gov