Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-11 @ 8:58 AM
Study NCT ID:
NCT04205734
Status:
SUSPENDED
Last Update Posted:
2023-10-10
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
Status:
SUSPENDED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID Restrictions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.
Detailed Description:
This is a cross-sectional study design. Subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. Data related to the diagnosis and interval assessment of enrolled subjects will also be collected.
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?: