Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea (ped PsO rPMS)

Post-Marketing Surveillance Study of Adalimumab (Humira) for Pediatric Chronic Severe Plaque Psoriasis Patients According to the Standard for "Re-Examination of New Drugs"

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 Overview

• Status: Completed
• Conditions: Psoriasis

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggido
    • Suwon-si, Gyeonggido, Korea, Republic of, 16499
      • Ajou University Hospital /ID# 207843

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric participants with chronic severe plaque psoriasis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediatric participants with chronic severe plaque psoriasis; Participants with chronic severe plaque psoriasis receiving adalimumab in routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 0 (informed consent) to up to 70 days following the last administration of Humira

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score.	Up to approximately 40 days
Percentage of Participants Achieving PASI 90 From Baseline	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-90 responders are the participants who achieved at least a 90% reduction (improvement) from baseline in PASI score.	Up to approximately 40 days
Percentage of Participants Achieving PASI 100 From Baseline	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-100 responders are the participants who achieved at least a 100% reduction (improvement) from baseline in PASI score.	Up to approximately 40 days
Change in Body Surface Area (BSA) from Baseline	BSA affected by psoriasis is assessed by the Investigator.	Up to approximately 40 days

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Psoriasis; Pediatric; Adalimumab; Humira; Post-marketing; Chronic severe plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: P18-839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No