A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT00365001
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 16, 2006
Status verified
Jun 2010
Completion
Apr 30, 2008

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. [ Time Frame: Days 1, 15 and 43 ]

Locations (10)

FacilityCityStateZIPSite coordinators
-AnnistonAlabama36207-
-ScottsdaleArizona85251-
-Little RockArkansas72202-
-JacksonvilleFlorida32216-
-Palm HarborFlorida34684-
-Royal OakMichigan48073-
-OmahaNebraska68154-
-Oklahoma CityOklahoma73103-
-DuncansvillePennsylvania16635-
-AustinTexas78704-

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