Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Study Identifier
P12-165
CT.gov Identifier
NCT01202565
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Patients will be enrolled in this PMOS if they fulfill all of the below criteria: 1. Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines 2. Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet ≥ 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score ≥ 10) 3. Adult (≥18 years of age) 4. Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines 5. Willing to provide informed consent if requested by the local law regulations
    Exclusion Criteria:
    Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS: 1. Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC) 2. Participate in another clinical/observational study

    Protocol Summary

    There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.

    The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 63776
    Chotoviny, Czech Republic, 391 32
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 58083
    Jihlava, Czech Republic, 58601
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 56762
    Klimkovice, Czech Republic, 74283
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 56763
    Klimkovice, Czech Republic, 74283
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 30742
    Kostelec nad Ohří, Czech Republic, 517 41
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 54503
    Prague, Czech Republic, 100 34
    Status
    Not applicable
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