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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00365001




Registration number
NCT00365001
Ethics application status
Date submitted
15/08/2006
Date registered
16/08/2006
Date last updated
11/06/2010

Titles & IDs
Public title
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
Scientific title
A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
Secondary ID [1] 0 0
WP18663
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tocilizumab [RoActemra/Actemra]
Treatment: Drugs - Methotrexate
Treatment: Drugs - Simvastatin

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: tocilizumab [RoActemra/Actemra]
10mg/kg iv on day 8

Treatment: Drugs: Methotrexate
10-25mg po/week

Treatment: Drugs: Simvastatin
40mg po on days 1, 15 and 43
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Timepoint [1] 0 0
Days 1, 15 and 43
Secondary outcome [1] 0 0
Pharmacokinetic parameters for tocilizumab.
Timepoint [1] 0 0
Days 11, 22, 29 and 36.
Secondary outcome [2] 0 0
CRP, IL-6, sIL-6R changes
Timepoint [2] 0 0
Throughout study
Secondary outcome [3] 0 0
AEs, laboratory parameters.
Timepoint [3] 0 0
Throughout study

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
New Zealand
State/province [10] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00365001
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries