A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Patients with inflammatory bowel disease (IBD) who require methotrexate (MTX)for treatment currently receive this drug by injection. MTX is also available as a pill that can be given by mouth but it is not known how well the drug enters the body in patients with Crohn's disease or ulcerative colitis. This study is being done to compare how much MTX enters the body when the drug is taken by mouth compared to when it is given by injection. If the drug is well absorbed, it may allow patients to receive the drug by mouth.

Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Interventions

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Methotrexate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult or pediatric patients with IBD (CD or UC) currently receiving MTX as part of their clinical care.
* Patients must be receiving weekly MTX at a dose between 7.5 and 40 mg/m2.
* Weight \>= 12 kg.
* Normal serum creatinine.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCRR-M01RR00240-1757

Identifier Type: -

Identifier Source: org_study_id