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OpenTrials
Completed

NCT Number: NCT00365001

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Christchurch, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tocilizumab [RoActemra/Actemra]

Drug

10mg/kg iv on day 8

methotrexate

Drug

10-25mg po/week

simvastatin

Drug

40mg po on days 1, 15 and 43

Primary outcomes

  1. Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.

    Time frame: Days 1, 15 and 43

Secondary outcomes

  1. Pharmacokinetic parameters for tocilizumab.

    Time frame: Days 11, 22, 29 and 36.

  2. CRP, IL-6, sIL-6R changes

    Time frame: Throughout study

  3. AEs, laboratory parameters.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study completion
2008
First posted
Aug 16, 2006
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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