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

NCT ID: NCT03925441

Last Updated: 2020-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-25

Study Completion Date

2019-08-06

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric participants with chronic severe plaque psoriasis

Participants with chronic severe plaque psoriasis receiving adalimumab in routine clinical practice

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Ajou University Hospital /ID# 207843

Suwon, Gyeonggido, South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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P18-839

Identifier Type: -

Identifier Source: org_study_id

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