Viewing Study NCT00365001



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Last Modification Date: 2024-10-26 @ 9:27 AM
Study NCT ID: NCT00365001
Status: COMPLETED
Last Update Posted: 2010-06-11
First Post: 2006-08-15

Brief Title: A Drug Interaction Study Between Tocilizumab Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Organization: Hoffmann-La Roche

Study Overview

Official Title: A Randomized Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis
Status: COMPLETED
Status Verified Date: 2010-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 10mgkg 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None