drugset / Trial / NCT01177228
Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
Summary
The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).
Timeline
- Start
- 2007-05
- Primary completion
- 2008-06
- Completion
- 2008-09
Publications
- Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
- Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vedolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Vedolizumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Vedolizumab | Monoclonal antibody | 10 mg/kg | Intravenous |