NCT03925441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2019

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

April 22, 2019

Last Update Submit

June 11, 2020

Conditions

Psoriasis

Keywords

Post-marketingAdalimumabHumiraPediatricChronic severe plaque psoriasisPsoriasis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

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

    Up to approximately 40 days

  • Percentage of Participants Achieving PASI 90 From Baseline

    Up to approximately 40 days

  • Percentage of Participants Achieving PASI 100 From Baseline

    Up to approximately 40 days

  • Change in Body Surface Area (BSA) from Baseline

    Up to approximately 40 days

Study Arms (1)

Pediatric participants with chronic severe plaque psoriasis

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

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric participants with chronic severe plaque psoriasis

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital /ID# 207843

Suwon, Gyeonggido, 16499, South Korea

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 24, 2019

Study Start

June 25, 2019

Primary Completion

August 6, 2019

Study Completion

August 6, 2019

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

KR(1)