A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: tocilizumab (Drug); Methotrexate (Drug); Simvastatin (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Clinical Details
Official title: A Randomized, Open-Label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Secondary outcome: Pharmacokinetic parameters for tocilizumab.CRP, IL-6, sIL-6R changes AEs, laboratory parameters.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
ANISTON, Alabama 36207, United States
SCOTTSDALE, Arizona 85251, United States
LITTLE ROCK, Arkansas 72202, United States
JACKSONVILLE, Florida 32216, United States
PALM HARBOR, Florida 34684, United States
OKLAHOMA CITY, Oklahoma 73103, United States
OKLAHOMA CITY, Oklahoma 73103, United States
DUNCANSVILLE, Pennsylvania 16635, United States
AUSTIN, Texas 78704, United States
Additional Information
Starting date: November 2005
Ending date: March 2008
Last updated: June 17, 2008
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