Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis
NCT ID: NCT02239666
Last Updated: 2017-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
899 participants
OBSERVATIONAL
2014-03-01
2017-01-05
Brief Summary
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Detailed Description
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Study Hypothesis: This study will estimate in each country the proportion of biologic treatment-naïve and biologic treatment-switching psoriasis subjects in the real-world having total clearance at 6 months after initiating a biologic.
The study population will include up to approximately 300 adults in each of up to 6 participating countries who have been diagnosed by their physicians with moderate to severe plaque psoriasis, and are initiating biologic therapy(biologic treatment-naïve or biologic treatment-switching) for plaque psoriasis.
Summary of Subject Eligibility Criteria: aged 18 or over; diagnosed with moderate to severe plaque psoriasis; initiating a biologic approved for psoriasis at study entry; able to fill out questionnaires; provided written informed consent; and not participating in a clinical trial utilizing an investigational agent in the 3 months prior to the first biologic dose.
Assessments: Skin clearance is the primary indicator of treatment effectiveness, and will be measured using the physician-reported PASI and sPGA. Other assessments will be by the following patient questionnaires: psoriasis symptom inventory (PSI), the dermatology life quality index (DLQI), the static patient's global assessment ( sPtGA), treatment satisfaction and global health status.
All subjects will be initiating biologic therapy at study entry. Therapy discontinuations, switches, and dosing changes during follow-up will be reported by the site and summarized.
Follow-up continues for approximately 12 months after first dose or until the subject is lost to follow-up or withdraws from the study (for any reason including death), whichever comes first. Where appropriate, data will be obtained for each subject during mandatory visits at 6 months (± 6 weeks) and 12 months (± 6 weeks) after first biologic dose, and at routine visits that occur during the follow-up period. To the extent possible data will also be collected at other usual care visits that occur during follow-up.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Moderate to Severe Plaque Psoriasis
Prospective cohort study of usual care for subjects initiating therapy for plaque psoriasis on approved biologic agents. A non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
NIS
This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
Interventions
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NIS
This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
Eligibility Criteria
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Inclusion Criteria
* subjects who will be initiating therapy with a biologic approved for moderate to severe psoriasis either for the first time (biologic treatment naive) or in course of switching to a different biologic agent
* subject who is able to complete questionnaires
* subject able to provide written informed consent
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Hammond
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
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Hot Springs, Arkansas, United States
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Rogers, Arkansas, United States
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Bakersfield, California, United States
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Burbank, California, United States
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Irvine, California, United States
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Sacramento, California, United States
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Aurora, Colorado, United States
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Aventura, Florida, United States
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Pembroke Pines, Florida, United States
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Alpharetta, Georgia, United States
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Macon, Georgia, United States
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Sandy Springs, Georgia, United States
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Carmel, Indiana, United States
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Indianapolis, Indiana, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Silver Spring, Maryland, United States
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Clarkston, Michigan, United States
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St Louis, Missouri, United States
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East Windsor, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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Gahanna, Ohio, United States
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Warren, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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West Jordan, Utah, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Bridgeport, West Virginia, United States
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Angers, , France
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Argenteuil, , France
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Besançon, , France
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Bordeaux, , France
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Brest, , France
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Chambray-lès-Tours, , France
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Le Mans, , France
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Limoges, , France
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Lyon, , France
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Nice, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Reims, , France
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Rennes, , France
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Saint-Priest-en-Jarez, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Bergen auf Rügen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Buxtehude, , Germany
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Dülmen, , Germany
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Erlangen, , Germany
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Eschweiler, , Germany
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Friedrichshafen, , Germany
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Gelsenkirchen-Feldmark, , Germany
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Greifswald, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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München, , Germany
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Münster, , Germany
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Osnabrück, , Germany
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Potsdam, , Germany
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Quedlinburg, , Germany
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Selters, , Germany
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Simmern, , Germany
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Ancona, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Cagliari, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Roma, , Italy
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Roma (RM), , Italy
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Rome, , Italy
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Siena, , Italy
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Verona, , Italy
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Airdrie, , United Kingdom
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Cardiff, , United Kingdom
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Christchurch, Dorset, , United Kingdom
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Dundee, , United Kingdom
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Durham, , United Kingdom
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Exeter, , United Kingdom
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Lincoln, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Poole, , United Kingdom
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Portsmouth, , United Kingdom
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Redhill, , United Kingdom
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Scunthorpe, , United Kingdom
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Stourbridge, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120363
Identifier Type: -
Identifier Source: org_study_id
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