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Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea (ped PsO rPMS)

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ClinicalTrials.gov Identifier: NCT03925441
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Psoriasis

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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 25, 2019
Actual Primary Completion Date : August 6, 2019
Actual Study Completion Date : August 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Group/Cohort
Pediatric participants with chronic severe plaque psoriasis
Participants with chronic severe plaque psoriasis receiving adalimumab in routine clinical practice



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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925441


Locations
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Korea, Republic of
Ajou University Hospital /ID# 207843
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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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: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: No
Keywords provided by AbbVie:
Post-marketing
Adalimumab
Humira
Pediatric
Chronic severe plaque psoriasis
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents