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

Completed

• Conditions: Psoriasis

• Registration Number: NCT03925441
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-24
• Study Start: 2019-06-25
• Primary Completion: 2019-08-06
• Study Completion: 2019-08-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Read More

Exclusion Criteria

• Participants with contraindication to adalimumab as listed in the approved Korean label.
• Participants with prior treatment with adalimumab.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Reported Any Treatment Emergent Serious Adverse Events (TESAE) OR Drug Reactions	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	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 Outcome Measures

Name	Time	Method
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	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.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 From Baseline	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.
Percentage of Participants Achieving PASI 100 From Baseline	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.
Percentage of Participants Achieving PASI 90 From Baseline	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.
Change in Body Surface Area (BSA) from Baseline	Up to approximately 40 days	BSA affected by psoriasis is assessed by the Investigator.

Trial Locations

Locations (1)

Ajou University Hospital /ID# 207843; 🇰🇷 Suwon-si, Gyeonggido, Korea, Republic of