Crohn's Disease Clinical Trial
Official title:
Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.
Adalimumab (ADM), a fully human tumor necrosis factor (TNF) antagonist, is effective for
treating patients with Crohn's disease (CD). A correlation between concentration and effect
was observed at distinct time points.
The aim was to evaluate the correlation of early longitudinal measurements of ADM with
different biological markers for disease activity and induction and maintenance of clinical
remission.
This is a prospective two-center open-label observational study in anti-TNF naïve patients
with moderate to severe CD induced with ADM 160/80 mg at week 0 and 2 and 40 mg every 2
weeks in monotherapy. All patients should be in need for TNF antagonist therapy and should
fulfill standard reimbursement criteria (Belgium). Serum samples were taken pre and post
first injection and at weeks 1, 2, 3, 4, 12, 26 and 52. Following parameters were
determined: C-reactive protein, albumin, TNF, ADM, antibodies to ADM, hemoglobin, platelet
count and leukocyte count. Clinical response and remission was evaluated using the
Harvey-Bradshaw index.
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Observational Model: Cohort, Time Perspective: Prospective
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