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Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"

NCT02578238 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2018-12-19

Study results available
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Summary

This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.

Conditions

  • Pediatric Crohn's Disease

Sponsors & Collaborators

Principal Investigators

  • Eunjung Gu, MS · AbbVie korea

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-24
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578238 on ClinicalTrials.gov