A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
NCT ID: NCT00365001
Last Updated: 2010-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
tocilizumab [RoActemra/Actemra]
10mg/kg iv on day 8
Methotrexate
10-25mg po/week
Simvastatin
40mg po on days 1, 15 and 43
2
tocilizumab [RoActemra/Actemra]
10mg/kg iv on day 8
Methotrexate
10-25mg po/week
Interventions
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tocilizumab [RoActemra/Actemra]
10mg/kg iv on day 8
Methotrexate
10-25mg po/week
Simvastatin
40mg po on days 1, 15 and 43
Eligibility Criteria
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Inclusion Criteria
* rheumatoid arthritis for \>=6 months;
* methotrexate for \>=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).
Exclusion Criteria
* concurrent treatment with any DMARD other than methotrexate;
* prior treatment with tocilizumab.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Anniston, Alabama, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Jacksonville, Florida, United States
Palm Harbor, Florida, United States
Royal Oak, Michigan, United States
Omaha, Nebraska, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Austin, Texas, United States
Christchurch, , New Zealand
Countries
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References
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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.
Other Identifiers
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WP18663
Identifier Type: -
Identifier Source: org_study_id
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