Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03663400
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2018-08-14
Brief Title:
Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies Blood and Stool Samples
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies Blood and Stool Samples
Status:
COMPLETED
Status Verified Date:
2022-08
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 prospective cohort study enrolling ulcerative colitis patients who initiate tofacitinib therapy Investigators will collect clinical data blood and stool samples prior to initiation of tofacitinib and at minimum monthly after the start of therapy They will collect tissue from colonoscopies prior to initiation of therapy and within 6 months on therapy Clinical characteristics and response to treatment will then be associated with genotype blood immune profiles stool microbiota and cellular and molecular profiles of the biopsies to generate a treatment response model Using predictors identified in our model we will then attempt to validate the model and findings with the OCTAVE Pfizer SPARC CCF and RISK CCF data
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?:
True
Is an FDA AA801 Violation?:
None