Official Title: “A Randomized, Open-Label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: tocilizumab
  • 10mg/kg iv on day 8
• Drug: Methotrexate
  • 10-25mg po/week
• Drug: Simvastatin
  • 40mg po on days 1, 15 and 43

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
  • Time Frame: Days 1, 15 and 43
    Safety Issue?: No

Secondary Measures

• Pharmacokinetic parameters for tocilizumab.
  • Time Frame: Days 11, 22, 29 and 36.
    Safety Issue?: No
• CRP, IL-6, sIL-6R changes
  • Time Frame: Throughout study
    Safety Issue?: No
• AEs, laboratory parameters.
  • Time Frame: Throughout study
    Safety Issue?: No

Inclusion Criteria:

• adult patients, 18-75 years of age;
• rheumatoid arthritis for >=6 months;
• methotrexate for >=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).

Exclusion Criteria:

• history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA;
• concurrent treatment with any DMARD other than methotrexate;
• prior treatment with tocilizumab.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00365001

Study ID Number: WP18663

ClinicalTrials.gov Identifier: NCT00365001

Health Authority: United States: Food and Drug Administration