drugset / Trial / NCT05205603
Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-01-15
- Primary completion
- 2024-01-15
- Completion
- 2025-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 4 g | Topical |
| Subject | Mesalamine | Small molecule | 6 g | Topical |
| Background | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |