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

NCT00365001 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2010-06-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

tocilizumab [RoActemra/Actemra]

10mg/kg iv on day 8

DRUG

Methotrexate

10-25mg po/week

DRUG

Simvastatin

40mg po on days 1, 15 and 43

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2008-04-30

Countries

  • United States
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365001 on ClinicalTrials.gov