Post-Marketing Surveillance Study of Adalimumab (Humira) for Pediatric Chronic Severe Plaque Psoriasis Patients According to the Standard for "Re-Examination of New Drugs"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Reported Any Treatment Emergent Serious Adverse Events (TESAE) OR Drug Reactions
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 4 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Percentage of Participants Who Reported Any Treatment Emergent Serious Adverse Events (TESAE) OR Drug Reactions
Time Frame: Day 0 (informed consent) to up to 70 days following the last administration of Humira
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.
Percentage of Participants Who Reported Any Unexpected Treatment Emergent Adverse Events OR Drug Reactions
Time Frame: Day 0 (informed consent) to up to 70 days following the last administration of Humira
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.
Secondary Outcomes
- Percentage of Participants Who Reported Any Treatment Emergent Non-Serious Adverse Event OR Drug Reaction(Day 0 (informed consent) to up to 70 days following the last administration of Humira)
- Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 From Baseline(Up to approximately 40 days)
- Percentage of Participants Achieving PASI 100 From Baseline(Up to approximately 40 days)
- Percentage of Participants Achieving PASI 90 From Baseline(Up to approximately 40 days)
- Change in Body Surface Area (BSA) from Baseline(Up to approximately 40 days)