Clinical trial NCT02239666: Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis
Official title: A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Dermatology, plaque psoriasis, biologic treatment, biologic naive
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-09-15
Enrollment: 899
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults greater than or equal to 18 years of age who have been diagnosed with moderate to severe plaque psoriasis based on treating physician's judgment

Brief summary: To estimate the real-world effectiveness of approved biologics in subjects with moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.

Detailed description: Plaque psoriasis is a chronic skin disease affecting 1-3% of US and European populations and severely impairs quality of life. Four biologics are authorized in Europe and the US for treatment of patients with moderate to severe psoriasis. Because complete skin clearance is rare with these agents, the treatment goal adopted by regulatory and reimbursement agencies is the proportion of patients achieving at least a 75% reduction from the subject's baseline PASI (Psoriasis Area and Severity Index) score or similarly, a sPGA \[static Physician's Global Assessment) score of 0 or 1. Specifically, this study will provide information on the effectiveness of approved biologics as they are used in clinical practice. This information is currently not consistently available from other sources, including existing psoriasis patient registries.

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.

Eligibility criteria: Inclusion Criteria:

* subjects who are greater than or equal to 18 YO diagnosed with moderate to severe plaque psoriasis
* 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:

- subjects who are participating in a clinical trial utilizing an investigational agent in the 3 months prior to the first biologic dose on study

Primary outcomes:
measure: PASI100
timeFrame: 6 months
Secondary outcomes:
measure: PASI100 (or sPASI=0)
timeFrame: 12 months
measure: PASI100 (or sPASI=0)
timeFrame: 6 months and 12 months
measure: sPGA=0
timeFrame: 6 months and 12 months
measure: Psoriasis Symptom Inventory (PSI) responders
timeFrame: 6 months and 12 months
measure: sPGA=0 or 1
timeFrame: 6 months and 12 months
measure: PSI=0
timeFrame: 6 months and 12 months
measure: Dermatology Life Quality Index (DLQI) =0
timeFrame: 6 months and 12 months
measure: Static Patient Global Assessment (sPtGA)
timeFrame: 6 months and 12 months
measure: Percent PASI improvement (or sPASI scores)
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Rogers
country: United States
facility: Research Site
state: Arkansas
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Burbank
country: United States
facility: Research Site
state: California
city: Irvine
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Alpharetta
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Sandy Springs
country: United States
facility: Research Site
state: Georgia
city: Carmel
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Silver Spring
country: United States
facility: Research Site
state: Maryland
city: Clarkston
country: United States
facility: Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: East Windsor
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Gahanna
country: United States
facility: Research Site
state: Ohio
city: Warren
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: West Jordan
country: United States
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state: Utah
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Bridgeport
country: United States
facility: Research Site
state: West Virginia
city: Angers
country: France
facility: Research Site
city: Argenteuil
country: France
facility: Research Site
city: Besancon Cedex
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Brest Cedex
country: France
facility: Research Site
city: Chambray les Tours
country: France
facility: Research Site
city: Le Mans Cedex 9
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Lyon Cedex 03
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Pierre-Benite cedex
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Reims cedex
country: France
facility: Research Site
city: Rennes Cedex 9
country: France
facility: Research Site
city: Saint Priest en Jarez
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Vandoeuvre les Nancy
country: France
facility: Research Site
city: Bergen auf Rügen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Buxtehude
country: Germany
facility: Research Site
city: Dülmen
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Eschweiler
country: Germany
facility: Research Site
city: Friedrichshafen
country: Germany
facility: Research Site
city: Gelsenkirchen-Feldmark
country: Germany
facility: Research Site
city: Greifswald
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Osnabrück
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Quedlinburg
country: Germany
facility: Research Site
city: Selters
country: Germany
facility: Research Site
city: Simmern
country: Germany
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Roma (RM)
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Airdrie
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Christchurch, Dorset
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Durham
country: United Kingdom
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
city: Lincoln
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Poole
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
city: Redhill
country: United Kingdom
facility: Research Site
city: Scunthorpe
country: United Kingdom
facility: Research Site
city: Stourbridge
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Edward Hammond
role: STUDY_DIRECTOR
References: