A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
1 other identifier
interventional
23
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2006
CompletedFirst Posted
Study publicly available on registry
August 16, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedJune 11, 2010
June 1, 2010
August 15, 2006
June 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Days 1, 15 and 43
Secondary Outcomes (3)
Pharmacokinetic parameters for tocilizumab.
Days 11, 22, 29 and 36.
CRP, IL-6, sIL-6R changes
Throughout study
AEs, laboratory parameters.
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Anniston, Alabama, 36207, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Little Rock, Arkansas, 72202, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Palm Harbor, Florida, 34684, United States
Unknown Facility
Royal Oak, Michigan, 48073, United States
Unknown Facility
Omaha, Nebraska, 68154, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Austin, Texas, 78704, United States
Unknown Facility
Christchurch, New Zealand
Related Publications (1)
Schmitt C, Kuhn B, Zhang X, Kivitz A, Grange S. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2012 Mar;50(3):218-23. doi: 10.5414/cp201613.
PMID: 22373834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 15, 2006
First Posted
August 16, 2006
Study Completion
April 1, 2008
Last Updated
June 11, 2010
Record last verified: 2010-06