Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab

Study Identifier
P11-984
CT.gov Identifier
NCT01077128
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:
    * Patients with moderate to severe chronic plaque psoriasis who are newly prescribed Humira (adalimumab) therapy (have never been treated with adalimumab before) and for whom the treating physician has made the decision that they are eligible for treatment with adalimumab in accordance with the terms of the local marketing authorization * Patients with moderate to severe chronic plaque psoriasis for whom Adalimumab is indicated and has been prescribed according to the current approved local SPC as long as the first administration of adalimumab is not older than two months and they have not had dose interruptions since the initiation of adalimumab, and the Investigator can provide all the needed source documentation including a completed DLQI questionnaire at the start of Adalimumab treatment. * Patient age ≥ 18 * Patient is willing to consent to data being collected and provided to Abbott
    Exclusion Criteria:
    * Patients who meet contraindications as outlined in the latest version of the local approved SPC * Patients who participate in another clinical/observational study * Patients who are not willing to sign an Informed Consent Form

    Protocol Summary

    Primary objective

    • To evaluate the quality of life of Adalimumab treated patients over a period of 12 months

    Secondary objectives

    • To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in accordance with the terms of the European marketing authorization.
    • To evaluate changes in patients quality of life according to treatment response over a 12-month period
    • To observe and assess the long term use and safety of Adalimumab as prescribed by the dermatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 43746
    Agrinio, Greece, 301 00
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 30197
    Amaliáda, Greece
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 30039
    Argos, Greece, 21200
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 29903
    Argyroúpoli, Greece
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 29819
    Athens, Greece, 10673
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 29949
    Athens, Greece, 11526
    Status
    Not applicable
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