Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.

NCT05071404 | Completed

• 1 other identifier: FIS-INF-2020-01
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Cases

Patients treated with infliximab sc.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with inflammatory bowel disease over 14 years of age who are being treated with infliximan sc.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Federico Arguelles Arias

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 8, 2021
• Study Start: November 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 17, 2021

Record last verified: 2020-10

Locations

ES (1)