NCT05205603

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 438 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Ulcerative Colitis
• Efficacy, Self
• Biologics
• Mesalazine

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-15
• Primary completion: 2024-01-15
• Completion: 2025-01-15
• First posted: 2022-01-25
• Last updated: 2023-12-05

Locations

11 sites across 1 country: China