Status:
COMPLETED
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00365001
End Date
April 1 2008
Last Update
June 11 2010
Active Locations (11)
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1
Anniston, Alabama, United States, 36207
2
Scottsdale, Arizona, United States, 85251
3
Little Rock, Arkansas, United States, 72202
4
Jacksonville, Florida, United States, 32216