Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02423512
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2015-04-17
Brief Title:
The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness A Biomarker Study
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Vedolizumab is a new medication being used for the treatment of Crohns disease and Ulcerative colitis It works by blocking specific white blood cells alpha 4-beta7 lymphocytes from migrating to areas of inflammation in the gastrointestinal tract Previous studies have shown that patients who have previous exposure to another type of medication for Crohns disease and Ulcerative colitis anti-TNF medications do not respond to vedolizumab as well as those who have never been exposed This study will investigate biologic markers in the blood and tissue the help identify possible reasons for this difference
Detailed Description:
Patients will be enrolled in the study when they are selected to initiate vedolizumab therapy Vedolizumab is an intravenous infusion given at increasing intervals The first infusion of vedolizumab will be considered baseline Patients may be enrolled at baseline or at colonoscopy prior to the first scheduled infusion of vedolizumab pre-treatment visit The standard induction protocol for vedolizumab consists of infusions at week 0 baseline week 2 and week 6 Vedolizumab as per standard-of-care is then continued at an interval of every 8 weeks following induction therapy Vedolizumab treatment will be prescribed as per standard practice and will be prescribed regardless of participation in this study Patients will not receive medication for the sole purpose of this research Treatment decisions including timing of wash out period between anti-TNf and vedolizumab will be made by the subjects physician and not per the research protocol There will not be a protocolized washout period for patients previously receiving anti-TNF therapy because treatment will be standard of care and per the directing physician
Standard of care laboratory tests will be performed by the clinical laboratory at Mount Sinai Hospital All other measurements will be completed at Prometheus Therapeutics Diagnostics in San Diego California or at a Takeda identified lab for vedolizumab concentrations and antibodies
Standard of care laboratory tests will be performed by the clinical laboratory at Mount Sinai Hospital All other measurements will be completed at Prometheus Therapeutics Diagnostics in San Diego California or at a Takeda identified lab for vedolizumab concentrations and antibodies
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IISR-2015-100947 | OTHER | Takeda Pharmaceuticals | None |