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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00365001

Enrollment

Registered

2006-08-16

Start date

Unknown

Completion date

2008-04-30

Last updated

2010-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGtocilizumab [RoActemra/Actemra]

10mg/kg iv on day 8

DRUGMethotrexate

10-25mg po/week

DRUGSimvastatin

40mg po on days 1, 15 and 43

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.	Days 1, 15 and 43

Secondary

Measure	Time frame
Pharmacokinetic parameters for tocilizumab.	Days 11, 22, 29 and 36.
CRP, IL-6, sIL-6R changes	Throughout study
AEs, laboratory parameters.	Throughout study

Countries

New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026