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Completed

NCT Number: NCT05071404

Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.

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

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Perform an efficacy assessment and monitoring of subcutaneous infliximab levels in patients with inflammatory bowel disease.

    Time frame: Up to 16 weeks.

    Number of hospitalizations of patients treated with subcutaneous infliximab suffering from inflammatory bowel disease.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

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

Acronym: Infliximab

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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