IBD
Conditions
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.
Interventions
DIAGNOSTIC_TESTMTX Assessment
Measurement of Methotrexate Polyglutamate levels.
Sponsors
Boston Children's Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Inclusion criteria
* IBD * Methotrexate Therapy
Exclusion criteria
* Inability to provide relevant samples
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methotrexate Polyglutamate Level | Samples will collected within 16 weeks of consent. | Measurement of Methotrexate Polyglutamate Levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation between Methotrexate Polyglutamate Levels and Lab Parameters | Samples will collected within 16 weeks of consent. | Compare the relationship between Methotrexate Polyglutamage levels and ESR,CRP, Hemoglobin, and Albumin |
| The correlation between Methotrexate Polyglutamate Levels and Clinical History | Samples will collected within 16 weeks of consent. | 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 |
Countries
United States
Outcome results
None listed