Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT07100093
Brief Summary:
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.
Detailed Description:
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:
NCT07100093
Study Brief:
Protocol Section:
NCT07100093