Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study
Who is this study for? Patients with moderate to severe ulcerative colitis
What treatments are being studied? Infliximab+Vedolizumab+Mesalazine
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Patients with moderate and severe ulcerative colitis;
• Subjects were above 18 years old and below 80 years;
• Indications of 5-ASA or biological treatment;
• According to the clinical symptoms, ulcerative colitis was diagnosed by endoscopic changes, pathological manifestations. The disease activity of UC was assessed according to the modified Mayo scoring system (modified Mayo: 6\
⁃ 12 for patients with moderate to severe ulcerative colitis);
• If the subject is a woman, a pregnancy test at baseline is needed to exclude pregnancy. Female patients must follow the contraceptive recommendations of the project;
• Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
Locations
Other Locations
China
People's Hospital of Chongqing
NOT_YET_RECRUITING
Chongqing
The Second Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
First People's Hospital of Foshan
RECRUITING
Guangzhou
Guangzhou Panyu Central Hospital
RECRUITING
Guangzhou
Nanhai Hospital, Southern Medical University
RECRUITING
Guangzhou
Shunde Hospital of Southern Medical University
RECRUITING
Guangzhou
the Sixth Affiliated Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Zhejiang University
NOT_YET_RECRUITING
Hanzhou
First Affiliated Hospital of Shantou University Medical College
RECRUITING
Shantou
Shengjing Hospital
RECRUITING
Shenyang
General Hospital of Tianjin Medical University
RECRUITING
Tianjin
Contact Information
Primary
Min Zhi
zhimin@mail.sysu.edu.cn
13825086505
Time Frame
Start Date:2022-01-15
Estimated Completion Date:2025-01-15
Participants
Target number of participants:438
Treatments
Placebo_comparator: Biologics group
Biologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.~vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.
Experimental: 5-ASA group
5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.~vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.~mesalazine: at a dose of 4-6g/d systemic or topical therapy