N/A
Completed N=143
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
Pediatric Crohn's Disease
Source: ClinicalTrials.gov NCT02578238 ↗
Enrolled (actual)
143
Serious AEs
5.6%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs — 18.18; 14.69; 5.59; 3.50 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs |
18.18; 14.69; 5.59; 3.50; 6.29; 2.80 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02578238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.