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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-24

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Crohn's Disease

Keywords

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Korea Humira Pediatric Crohn's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants With Pediatric CD

Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)
* Patients who have given written authorization to use their personal health data for the purposes of this study.

Exclusion Criteria

* Any contraindications to Humira as listed on the approved product market authorization (labeling)
* Patients who is participating on other clinical trials.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eunjung Gu, MS

Role: STUDY_DIRECTOR

AbbVie korea

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P15-619

Identifier Type: -

Identifier Source: org_study_id