Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775732
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2021-02-25
Brief Title:
Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease
Sponsor:
Imelda GI Clinical Research Center
Organization:
Imelda GI Clinical Research Center
Study Overview
Official Title:
Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease a Pragmatic Trial
Status:
COMPLETED
Status Verified Date:
2021-07
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:
None
Brief Summary:
This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018 An ultra-proactive IFX TDM algorithm is applied as follows All patients have an ELISA TL measurement at baseline of which the result determined the follow-up pathway A TL between 3-7μgmL continuation at same dose and interval B TL 7μgmL interval prolongation allowed C TL 3μgmL interval shortening with minimum 2 weeks with the next IFX TL measured using a POCT i If the POCT showed an IFX TL 3μgmL dose was optimized ad hoc using a linear dosing formula Dosen TL target Dose n-1 TL measured followed by a new POCT test at next visit with the same interval ii If the POCT showed an IFX TL 3µgmL no additional dose was given and routine TL testing with ELISA was retaken at next visit At every visit this algorithm was reapplied to all patients
The patients from cohort A will be compared with the patients from cohort B The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms Data will be collected retrospectively to avoid treatment optimization bias
The patients from cohort A will be compared with the patients from cohort B The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms Data will be collected retrospectively to avoid treatment optimization bias
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None