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

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-

Find similar trials in Anniston, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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