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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
438
Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks
Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks
Mesalazine, 4-6g/d, systemic and/or topical administration
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
...and 1 more locations
endoscopic remission rate at 12 months
endoscopic remission rate at 12 months
Time frame: 12 months after first intervention administration
normalization rate of serum biomarker at 12 months
normalization rate of serum biomarker at 12 months
Time frame: 12 months after first intervention administration
normalization rate of serum biomarker at 6 months
normalization rate of serum biomarker at 6 months
Time frame: 6 months after first intervention administration
clinical remission rate at 12 months
clinical remission rate at 12 months
Time frame: 12 months after first intervention administration
clinical remission rate at 6 months
clinical remission rate at 6 months
Time frame: 6 months after first intervention administration
clinical response rate at 12 months
clinical response rate at 12 months
Time frame: 12 months after first intervention administration
clinical response rate at 6 months
clinical response rate at 6 months
Time frame: 6 months after first intervention administration
endoscopic remission rate at 6 months
endoscopic remission rate at 6 months
Time frame: 6 months after first intervention administration
endoscopic response rate at 12 months
endoscopic response rate at 12 months
Time frame: 12 months after first intervention administration
endoscopic response rate at 6 months
endoscopic response rate at 6 months
Time frame: 6 months after first intervention administration
life quality changes at 12 months
life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months
Time frame: 12 months after first intervention administration
life quality changes at 6 months
life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months
Time frame: 6 months after first intervention administration
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