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

Psoriasis Clinical Trial

— ped PsO rPMS  

Official 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925441
• Other study ID #: P18-839
• Status: Completed
• Start date: June 25, 2019
• Est. completion date: August 6, 2019

Study information

• Verified date: June 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 6, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital /ID# 207843	Suwon-si	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Body Surface Area (BSA) from Baseline	BSA affected by psoriasis is assessed by the Investigator.	Up to approximately 40 days

External Links

•   clinical study report synopsis