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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01077128 |
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Date of registration:
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25/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab
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Scientific title:
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[E S] A Greek, Post-marketing, Observational Study of the quAlity of Life in Patients With Psoriasis Treated With Adalimumab - GOAL Study |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01077128 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Athina Katsavou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie Pharmaceuticals S.A. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Primary Outcome(s)
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Mean Change of Dermatology Life Quality Index (DLQI) Scores
[Time Frame: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)]
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Secondary Outcome(s)
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Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
[Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)]
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Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region
[Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)]
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Assessment of 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
[Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)]
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Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
[Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)]
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Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
[Time Frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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