drugset / Trial / NCT02954159
Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of this study is to assess if a combination therapy of tacrolimus and vedolizumab is superior to vedolizumab monotherapy for induction of remission in moderate to severe UC, and its effect on long and short-term outcomes including colectomy rate. Secondary aim of this study is to assess the safety of tacrolimus as an induction agent in patients with UC.
Timeline
- Start
- 2017-05-18
- Primary completion
- 2019-01-31
- Completion
- 2019-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |
| Comparator | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |