Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT05071404
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Detailed Description

Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Treatment is prior to and independent of the patient's participation in the study and is governed by clinical judgment criteria and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

Patients are older than 14 years who suffer from inflammatory bowel disease and who receive remsima as routine treatment.

The source of information will be the patient's medical history.

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-11-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-08
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Patients with inflammatory bowel disease.
• Over 14 years old.
• Receive Remsin as a treatment for his disease. And always this treatment that the patient is going to receive is governed by the criteria of clinical judgment and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

Exclusion Criteria

• Patients with inflammatory bowel disease under 14 years of age.
• Or older than this age with inflammatory bowel disease who do not attend the established check-ups

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease.	Up to 16 weeks.	Number of hospitalizations of patients treated with subcutaneous infliximab suffering from inflammatory bowel disease.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain