Back to resultsA Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
tocilizumab [RoActemra/Actemra]
Methotrexate
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Secondary Outcome Measures
Pharmacokinetic parameters for tocilizumab.
CRP, IL-6, sIL-6R changes
AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00365001
Brief Title
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
10mg/kg iv on day 8
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
10-25mg po/week
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
40mg po on days 1, 15 and 43
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Time Frame
Days 1, 15 and 43
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters for tocilizumab.
Time Frame
Days 11, 22, 29 and 36.
Title
CRP, IL-6, sIL-6R changes
Time Frame
Throughout study
Title
AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Aniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
City
Christchurch
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
22373834
Citation
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.
Results Reference
derived
Learn more about this trial
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
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