Imatinib is a member of a new class of drugs known as signal transduction inhibitors. The purpose of this study is to evaluate the efficacy, safety and tolerability of imatinib in the treatment of rheumatoid arthritis in combination with methotrexate in patients who do not respond satisfactorily to standard treatment, e.g. methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Novartis Investigative site
Graz, Austria
Novartis Investigative site
Vienna, Austria
Novartis Investigative site
Vienna, Austria
Efficacy of imatinib in combination with MTX in pts with active RA by assessing response to treatment(ACR20) after 3 mos compared to MTX alone
Overall safety and tolerability of imatinib in combination with MTX in pts with active RA over 3 mos compared to MTX alone.
Efficacy of imatinib in combination with MTX by assessing the response to treatment (ACR50 and ACR70 criteria; DAS28/EULAR28) after 3 mos compared to MTX alone
Effect of imatinib in combination with MTX on ACR components after 3 mos compared to MTX alone
Effect of imatinib in combination with MTX on rheumatoid factor concentrations
Determine time of onset of clinical response to imatinib in combination with MTX
Determine retention on treatment of imatinib in combination with MTX over 3 mos
Assess pt's quality of life by means of the Euro QoL 50 Health Questionnaire
Assess in a subset of pts pharmacokinetics of imatinib and MTX and their potential interactions when co-administered
Assess pharmacodynamic effect of imatinib in combination with MTX on liver enzymes, hematology and kidney function
Explore potential for RA and drug-specific biomarkers
Explore decrease in synovitis by means of ultrasound in a sub-set of patients.
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Novartis Investigative site
Winnipeg, Manitoba, Canada
Novartis Investigative site
Toronto, Ontario, Canada
Novartis Investigative site
Montreal, Quebec, Canada
Novartis Investigative site
Sainte-Foy, Quebec, Canada
Novartis Investigative site
Helsinki, Finland
Novartis Investigative site
Husu, Finland
Novartis Investigative site
Cannock, Staffordshire, United Kingdom
...and 5 more locations