A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in
combination with tocilizumab to assess any potential drug interactions. Patients will be
randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate
(10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and
43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time
on study treatment is <3 months, and the target sample size is <100 individuals.