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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03925441

Recruitment Status Completed

First Posted April 24, 2019

Last update posted June 12, 2020

Study Description

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.

  • Condition or Disease:Psoriasis
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 2 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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"
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: August 2019
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 4 to 17 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Pediatric participants with chronic severe plaque psoriasis
Criteria

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.

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. AbbVie

More Information
  • Responsible Party: AbbVie
  • ClinicalTrials.gov Identifier: NCT03925441 History of Changes
  • Other Study ID Numbers: P18-839
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: June 12, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by AbbVie: Post-marketing
    Adalimumab
    Humira
    Pediatric
    Chronic severe plaque psoriasis
    Psoriasis
  • Additional relevant MeSH terms: Psoriasis