Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 9:44 PM
Study NCT ID:
NCT05071404
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Study Overview
Official Title:
Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels in Patients With Inflammatory Bowel Disease.
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Infliximab
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: