Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603337
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Sequencing in Inflammatory Bowel Diseases IBD Therapy the Latium Net
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sequencing in Inflammatory Bowel Diseases IBD Therapy the Latium Net A Key Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIKE
Brief Summary:
Patients with IBD both UC and CD who fulfil the inclusion and exclusion criteria will be included consecutively
Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included
Prospective cohort Consecutive patients with IBD who are starting from clinical practice new biologicalsmall molecule therapies failure already exposed to a mechanism of action for anti TNF-alpha more than one molecule is allowed and who belong to the Lazio Regional Health System
Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre CEMAD of the Foundation and to all the other IBD Units of all the centres specified in Annex 1 Based on the number of patients referred to the clinics we estimate 112 patients per month the time for recruitment is 24 months
Potential study participants will receive oral and written information about the study Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP
Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included
Prospective cohort Consecutive patients with IBD who are starting from clinical practice new biologicalsmall molecule therapies failure already exposed to a mechanism of action for anti TNF-alpha more than one molecule is allowed and who belong to the Lazio Regional Health System
Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre CEMAD of the Foundation and to all the other IBD Units of all the centres specified in Annex 1 Based on the number of patients referred to the clinics we estimate 112 patients per month the time for recruitment is 24 months
Potential study participants will receive oral and written information about the study Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP
Detailed Description:
Multicenter ambispectic observational study with drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None