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Completed

NCT Number: NCT03925441

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou University Hospital /ID# 207843

Suwon, Gyeonggido, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

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

    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.

  2. Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 From Baseline

    Time frame: Up to approximately 40 days

    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.

  3. Percentage of Participants Achieving PASI 90 From Baseline

    Time frame: Up to approximately 40 days

    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.

  4. Percentage of Participants Achieving PASI 100 From Baseline

    Time frame: Up to approximately 40 days

    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.

  5. Change in Body Surface Area (BSA) from Baseline

    Time frame: Up to approximately 40 days

    BSA affected by psoriasis is assessed by the Investigator.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: ped PsO rPMS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2019
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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