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COMPLETED
NCT05205603
PHASE4

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

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

438

Start Date

2022-01-15

Completion Date

2025-01-15

Last Updated

2026-04-29

Healthy Volunteers

No

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

Locations (11)

People's Hospital of Chongqing

Chongqing, Chongqing Municipality, China

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

First People's Hospital of Foshan

Guangzhou, Guangdong, China

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Nanhai Hospital, Southern Medical University

Guangzhou, Guangdong, China

Shunde Hospital of Southern Medical University

Guangzhou, Guangdong, China

First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Shengjing Hospital

Shenyang, Liaoning, China

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Zhejiang University

Hanzhou, Zhejiang, China