Rheumatoid Arthritis Clinical Trial
Official title:
Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)
Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α)
approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs
(DMARDs) and for the treatment of severe, active and progressive RA in adults not previously
treated with methotrexate.
However, almost one third of patients have no response and approximately 15% develop
antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a
relationship between adalimumab concentration and clinical response obtained after 6 month
of treatment. Furthermore adalimumab concentration measured 3 months after initiation seems
to predict the clinical response at 6 months.
There is an important inter individual pharmacokinetic variability of adalimumab. Side
effects may occur at the recommended dose and more than 3 months of treatment are generally
required to estimate the clinical response.
A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the
response and to avoid dose related side effects. To date there is no definite adalimumab
target concentration predictive of the clinical response to allow such a pharmacologic
monitoring.
n/a
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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