A prospective, non-commercial, multicenter study will be conducted in a cohort of patients initiating induction therapy and a cohort of patients with stable treatment with ustekinumab.
The present study aims to evaluate the association between serum levels (trough) of Ustekinumab and clinical, biological, endoscopic and radiological response/remission in patients with Crohn's disease, in order to determine threshold levels at induction and maintenance that may be predictors of efficacy. Working hypothesis: Serum Ustekinumab levels in Crohn's disease patients are correlated with clinical, biochemical and endoscopic/radiological response/remission. Patients with an established diagnosis of Crohn's disease by usual criteria (clinical, analytical, endoscopic, radiological and/or histological) who initiate treatment with Ustekinumab (induction cohort) or who are on maintenance treatment with Ustekinumab (maintenance cohort) in a stable dosis (a minimum of 6 months) will be included.
Study Type
OBSERVATIONAL
Enrollment
100
Ustekinumab trough levels (prior to administration of the next dose of the drug) will be determined by enzyme-linked immunoadsorption assay (ELISA) methodology.
Hospital Universitario La Paz
Madrid, Spain
biological remission
association between serum levels of ustekinumab and biological remission in induction
Time frame: week 8 and week 16
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