NCT03925441 - Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea | Crick

Overview

The objective of this study is to evaluate the real world safety and effectiveness of adalimumab (Humira) for the treatment of Korean patients with pediatric chronic severe plaque psoriasis under a routine treatment practice.

Study Type

OBSERVATIONAL

Enrollment

2

Conditions

Psoriasis

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children and adolescents who are diagnosed with pediatric chronic severe plaque psoriasis. * Prior to participating in the study, adalimumab treatment was determined according to clinical judgement of the physician. * Participants (or legal representative) who voluntarily agreed to participate in this study and signed informed consent. Exclusion Criteria: * Participants with contraindication to adalimumab as listed in the approved Korean label. * Participants with prior treatment with adalimumab.

Locations (1)

Ajou University Hospital /ID# 207843

Suwon, Gyeonggido, South Korea

Outcomes

Primary Outcomes

Percentage of Participants Who Reported Any Treatment Emergent Serious Adverse Events (TESAE) OR Drug Reactions

An adverse event (AE) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relations. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

Time frame: Day 0 (informed consent) to up to 70 days following the last administration of Humira

Percentage of Participants Who Reported Any Unexpected Treatment Emergent Adverse Events OR Drug Reactions

An adverse event (AE) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relations. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. Unexpected adverse events are the ones that do not appear on the label of the drug.

Time frame: Day 0 (informed consent) to up to 70 days following the last administration of Humira

Secondary Outcomes

Percentage of Participants Who Reported Any Treatment Emergent Non-Serious Adverse Event OR Drug Reaction

An adverse event (AE) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relations. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.