A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365001
• Other study ID #: WP18663
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2006
• Last updated: June 10, 2010
• Est. completion date: April 2008

Study information

• Verified date: June 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
10mg/kg iv on day 8
• Methotrexate
10-25mg po/week
• Simvastatin
40mg po on days 1, 15 and 43

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.		Days 1, 15 and 43	No
Secondary	Pharmacokinetic parameters for tocilizumab.		Days 11, 22, 29 and 36.	No
Secondary	CRP, IL-6, sIL-6R changes		Throughout study	No
Secondary	AEs, laboratory parameters.		Throughout study	No