A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Phase 1
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00365001
- Lead Sponsor
- Hoffmann-La Roche
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tocilizumab [RoActemra/Actemra] - 2 tocilizumab [RoActemra/Actemra] - 1 Methotrexate - 1 Simvastatin - 2 Methotrexate -
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. Days 1, 15 and 43
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters for tocilizumab. Days 11, 22, 29 and 36. CRP, IL-6, sIL-6R changes Throughout study AEs, laboratory parameters. Throughout study