Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

Study Identifier
P12-077
CT.gov Identifier
NCT01155570
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

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:
    All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be * those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or * patients with intractable eruptions of joint signs/symptoms.
    Exclusion Criteria:
    Contraindications according to the Package Insert include patients who have any of the following: * serious infections * tuberculosis * a history of hypersensitivity to any ingredient of Humira * demyelinating disease or a history of demyelinating disease * congestive cardiac failure.

    Protocol Summary

    The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:

    • unknown adverse drug reactions, especially clinically significant adverse reactions
    • incidence and conditions of occurrence of adverse reactions in the clinical setting
    • factors that may affect the safety and effectiveness of Humira.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 41606
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 41769
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 41810
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 56131
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 56251
    Aichi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 56252
    Aichi, Japan
    Status
    Not applicable
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