Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05071404

Acronym

Infliximab

Enrollment

Registered

2021-10-08

Start date

2020-11-01

Completion date

2021-02-01

Last updated

2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results