Determination of Ustekinumab Levels in Patients With Crohn's Disease

• Conditions: Crohn Disease

• Registration Number: NCT05057832
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

Detailed Description

Prospective follow-up observational study carried out with patients from the Virgen de Macarena University Hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-05-01
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-09-27
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Over 18 years.
• Patients treated with ustekinumab in induction and maintenance phase.
• They must agree to participate in the clinical study, having previously signed the informed consent.

Exclusion Criteria

• Any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine breakpoints.	Up to 44 weeks.	To determine the breakpoints for ustekinumab levels between which clinical remission is expected in patients with inflammatory bowel disease.

Trial Locations

Locations (1)

Hospital Universitario Virgen de Macarena; 🇪🇸 Sevilla, Spain