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Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
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
Infliximab
Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks
Vedolizumab
Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks
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