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NCT04205734 Clinical Trial

Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease

IBD Clinical Trial

Official title:
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04205734
Other study ID # IRB-P00028947
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date January 30, 2021
Est. completion date December 31, 2024

Study information
Verified date October 2023
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 1 Year to 21 Years
Eligibility Inclusion Criteria: - IBD - Methotrexate Therapy Exclusion Criteria: - Inability to provide relevant samples

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MTX Assessment
Measurement of Methotrexate Polyglutamate levels.

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Methotrexate Polyglutamate Level Measurement of Methotrexate Polyglutamate Levels Samples will collected within 16 weeks of consent.
Secondary The correlation between Methotrexate Polyglutamate Levels and Lab Parameters Compare the relationship between Methotrexate Polyglutamage levels and ESR,CRP, Hemoglobin, and Albumin Samples will collected within 16 weeks of consent.
Secondary The correlation between Methotrexate Polyglutamate Levels and Clinical History Do Methotrexate Polyglutamate Levels Predict Clinical Outcome as Measured by Disease Activity Indices, including PUCAI for ulcerative colitis and PCDAI for patients with Crohn Disease Samples will collected within 16 weeks of consent.
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