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Dose Effect Relationship of MTX and IBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531593
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:
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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Liver Fibroses Methotrexate Diagnostic Test: Ultrasound Elastography

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dose Effect Relationship of Methotrexate and Hepatic Fibrosis in Patients With Inflammatory Bowel Disease
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
US Elastography
All subjects will undergo one ultrasound elastography examination after consent.
Diagnostic Test: Ultrasound Elastography
Ultrasound elastography is a new, noninvasive technique that can assess the stiffness of the liver by the evaluation of how sound waves propagate through the liver parenchyma.




Primary Outcome Measures :
  1. Primary Objective - correlation between velocities of shear wave elastography and cumulative dose of Methotrexate (MTX) in patients with Inflammatory Bowel Disease (IBD). [ Time Frame: 2/1/2017-10/31/2017 ]
    To evaluate the correlation between velocities of shear wave elastography and cumulative dose of Methotrexate (MTX) in patients with Inflammatory Bowel Disease (IBD).


Secondary Outcome Measures :
  1. Secondary Objective - correlate hepatic enzymes elevation and ultrasound elastography velocities [ Time Frame: 2/1/2017-10/31/2017 ]
    To correlate hepatic enzymes elevation and ultrasound elastography velocities.

  2. Third Objective - changes in shear wave velocity [ Time Frame: 2/1/2017-10/31/2017 ]
    To assess if changes in shear wave velocity due to Methotrexate are influenced by other risk factors like obesity, alcohol ingestion, smoking

  3. Fourth Objective - correlate ultrasound elastography findings with fibrosis markers [ Time Frame: 2/1/2017-10/31/2017 ]
    To correlate ultrasound elastography findings with fibrosis markers: AST/ALT ratio (AST (U/L0/ALT (U/L); AST/platelet ratio index (AST/upper limit of normal)/Platelet count (109/L) X 100



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Ages Eligible for Study:   2 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients ages 2-22 whom have a diagnosis of IBD can participate in our study. We will recruit a total of 100 subjects; 25 control subjects and 75 subjects whom are taking Methotrexate for their IBD.
Criteria

Inclusion Criteria:

  • Patients age 2-22 years of age who have a diagnosis of IBD and consent to our study.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531593


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Publications of Results:

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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT03531593    
Other Study ID Numbers: 16040304
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Mercy Hospital Kansas City:
MTX
IBD
US Elastography
Liver Fibrosis
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Liver Cirrhosis
Fibrosis
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Liver Diseases