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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Unnamed facility
Anniston, Alabama, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Jacksonville, Florida, United States
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Time frame: Days 1, 15 and 43
Pharmacokinetic parameters for tocilizumab.
Time frame: Days 11, 22, 29 and 36.
CRP, IL-6, sIL-6R changes
Time frame: Throughout study
AEs, laboratory parameters.
Time frame: Throughout study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Palm Harbor, Florida, United States
Unnamed facility
Royal Oak, Michigan, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
Unnamed facility
Duncansville, Pennsylvania, United States
Unnamed facility
Austin, Texas, United States
...and 1 more locations