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

NCT02578238 | Completed Results

• 1 other identifier: P15-619
• Study Type: observational
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Korea; Humira; Pediatric Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs

  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]).

Study Arms (1)

Participants With Pediatric CD

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

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Regarding Medicine Information

MeSH Terms

Conditions

Pediatric Crohn's disease

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Eunjung Gu, MS

  AbbVie korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 16, 2015
• Study Start: September 24, 2015
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-05