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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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 facts

Study ID

NCT00365001

Run by

Hoffmann-La Roche

People needed

23

Expected to finish

2008-04-01

Last updated by the study team

2010-06-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Jacksonville, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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