Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.

Inflammatory Bowel Diseases Clinical Trial

— Infliximab  

Official title:

Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels in Patients With Inflammatory Bowel Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071404
• Other study ID #: FIS-INF-2020-01
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: October 2020
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease.	Number of hospitalizations of patients treated with subcutaneous infliximab suffering from inflammatory bowel disease.	Up to 16 weeks.