Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
- Conditions
- IBD
- Registration Number
- NCT04205734
- Lead Sponsor
- Boston Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 100
- IBD
- Methotrexate Therapy
- Inability to provide relevant samples
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Methotrexate Polyglutamate Level Samples will collected within 16 weeks of consent. Measurement of Methotrexate Polyglutamate Levels
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States