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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00365001
First received: August 15, 2006
Last updated: June 10, 2010
Last verified: June 2010

August 15, 2006
June 10, 2010
Not Provided
Not Provided
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. [ Time Frame: Days 1, 15 and 43 ] [ Designated as safety issue: No ]
PK parameters for simvastatin, and metabolite, and methotrexate and metabolite (AUC last, AUCinf, Cmax, Tmax, T1/2, CL/F).
Complete list of historical versions of study NCT00365001 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic parameters for tocilizumab. [ Time Frame: Days 11, 22, 29 and 36. ] [ Designated as safety issue: No ]
  • CRP, IL-6, sIL-6R changes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Pharmacokinetics: PK parameters for tocilizumab. Pharmacodynamics: CRP, IL-6, sIL-6R changes. Safety: AEs, laboratory parameters.
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Experimental: 1
    Interventions:
    • Drug: tocilizumab [RoActemra/Actemra]
    • Drug: Methotrexate
    • Drug: Simvastatin
  • Active Comparator: 2
    Interventions:
    • Drug: tocilizumab [RoActemra/Actemra]
    • Drug: Methotrexate
Schmitt C, Kuhn B, Zhang X, Kivitz A, Grange S. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2012 Mar;50(3):218-23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
April 2008
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   New Zealand
 
NCT00365001
WP18663
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP