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

May 24, 2018 updated by: AbbVie

Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the "New-Drug Re-examination"

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric CD patients who have been prescribed Humira® by the treating physician

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants With Pediatric CD
Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
Time Frame: From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).
An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded.
From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2015

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Crohn's Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe