Dose Effect Relationship of MTX and IBD
Completed
Conditions studied: Inflammatory Bowel Diseases, Liver Fibroses, Methotrexate
In brief
Currently there are no guidelines for monitoring hepatic fibrosis associated with long term MTX use. Routine liver biopsies are not being done as a part of surveillance due to potential complications like bleeding and pneumothorax. Non-invasive markers like gammaglamyltransferase (GGTP), Alkaline Phosphatase (AlkPhos), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are deranged at a late stage and may not be helpful in detecting early fibrosis. The current study will utilize a sensitive, but noninvasive, test to evaluate for hepatic fibrosis. We are attempting to screen for early detection of fibrosis due to MTX before it progresses to irreversible cirrhosis and end-stage liver disease. Based on the results of this pilot study, ultrasound elastography could be used to prospectively study a larger population to establish guidelines for monitoring safety and hepatic complications with MTX. The influence of other co-morbid factors like obesity, alcohol ingestion and smoking is critical to identifying high risk patients who may require closer monitoring. We follow close to 550 patients with IBD. If we presume that at least 20% patients are currently receiving methotrexate, we will be able to recruit enough patients for this pilot study.
Key facts
- Study ID
- NCT03531593
- Run by
- Children's Mercy Hospital Kansas City
- People needed
- 64
- Starts
- 2017-02-01
- Expected to finish
- 2018-05-31
- Last updated by the study team
- 2018-07-17
Who can join
Age: 2 and older, up to 22. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients age 2-22 years of age who have a diagnosis of IBD and consent to our study.
You may not qualify if…
- Patient is unable to tolerate an ultrasound elastography examination.
- Target enrollment for the MTX dose category in which the patient fits has been completed.
- Any preexisting liver disease
Where it is running
- Children's Mercy Hospital — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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