Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239666
• Other study ID #: 20120363
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: August 2, 2017
• Start date: March 1, 2014
• Est. completion date: January 5, 2017

Study information

• Verified date: August 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 899
• Est. completion date: January 5, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Other:
• NIS
This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.

Locations

Country	Name	City	State
France	Research Site	Angers
France	Research Site	Argenteuil
France	Research Site	Besancon Cedex
France	Research Site	Bordeaux
France	Research Site	Brest Cedex
France	Research Site	Chambray les Tours
France	Research Site	Le Mans Cedex 9
France	Research Site	Limoges
France	Research Site	Lyon Cedex 03
France	Research Site	Nice
France	Research Site	Pierre-Benite cedex
France	Research Site	Poitiers
France	Research Site	Reims cedex
France	Research Site	Rennes Cedex 9
France	Research Site	Saint Priest en Jarez
France	Research Site	Toulouse Cedex 9
France	Research Site	Vandoeuvre les Nancy
Germany	Research Site	Bergen auf Rügen
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bonn
Germany	Research Site	Buxtehude
Germany	Research Site	Dülmen
Germany	Research Site	Erlangen
Germany	Research Site	Eschweiler
Germany	Research Site	Friedrichshafen
Germany	Research Site	Gelsenkirchen-Feldmark
Germany	Research Site	Greifswald
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	München
Germany	Research Site	Münster
Germany	Research Site	Osnabrück
Germany	Research Site	Potsdam
Germany	Research Site	Quedlinburg
Germany	Research Site	Selters
Germany	Research Site	Simmern
Italy	Research Site	Ancona
Italy	Research Site	Bergamo
Italy	Research Site	Bologna
Italy	Research Site	Brescia
Italy	Research Site	Cagliari
Italy	Research Site	Genova
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Modena
Italy	Research Site	Pavia
Italy	Research Site	Perugia
Italy	Research Site	Roma
Italy	Research Site	Roma (RM)
Italy	Research Site	Rome
Italy	Research Site	Siena
Italy	Research Site	Verona
United Kingdom	Research Site	Airdrie
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Christchurch, Dorset
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Durham
United Kingdom	Research Site	Exeter
United Kingdom	Research Site	Lincoln
United Kingdom	Research Site	London
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Poole
United Kingdom	Research Site	Portsmouth
United Kingdom	Research Site	Redhill
United Kingdom	Research Site	Scunthorpe
United Kingdom	Research Site	Stourbridge
United Kingdom	Research Site	Wolverhampton
United States	Research Site	Alpharetta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Aventura	Florida
United States	Research Site	Bakersfield	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bridgeport	West Virginia
United States	Research Site	Burbank	California
United States	Research Site	Carmel	Indiana
United States	Research Site	Clarkston	Michigan
United States	Research Site	Dallas	Texas
United States	Research Site	East Windsor	New Jersey
United States	Research Site	Gahanna	Ohio
United States	Research Site	Hot Springs	Arkansas
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Irvine	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Macon	Georgia
United States	Research Site	New York	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Overland Park	Kansas
United States	Research Site	Owensboro	Kentucky
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Roanoke	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Rogers	Arkansas
United States	Research Site	Sacramento	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	Sandy Springs	Georgia
United States	Research Site	Seattle	Washington
United States	Research Site	Silver Spring	Maryland
United States	Research Site	Warren	Ohio
United States	Research Site	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI100	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	6 months
Secondary	PASI100 (or sPASI=0)	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	12 months
Secondary	PASI100 (or sPASI=0)	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI100 represents a 100% improvement from baseline, that is, complete clearance. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	6 months and 12 months
Secondary	sPGA=0	Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).	6 months and 12 months
Secondary	Psoriasis Symptom Inventory (PSI) responders	A PSI responder is defined as a total PSI score less than or equal to 8, with no single item score more than 1	6 months and 12 months
Secondary	sPGA=0 or 1	Physician-completed static Patient Global Assessment (sPGA) is a one-off assessment of severity of psoriasis on 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).	6 months and 12 months
Secondary	PSI=0	Psoriasis Symptom Inventory (patient questionnaire) score of 0	6 months and 12 months
Secondary	Dermatology Life Quality Index (DLQI) =0	Measures functional disability of subjects with dermatological disorders. A self-administered 10-item questionnaire containing 6 functional scales (symptoms/feelings, sleep, leisure/daily activities, school/holidays, personal relationship and treatment).	6 months and 12 months
Secondary	Static Patient Global Assessment (sPtGA)	Patient assessment of the severity of their psoriasis on a 6-point scale ranging from 0 (clear; no psoriasis) to 6 (very severe).	6 months and 12 months
Secondary	Percent PASI improvement (or sPASI scores)	Physician-completed Psoriasis Area and Severity Index (PASI) measuring for each study subject average redness, thickness and scaliness of plaque psoriasis regions, weighted by area of involvement in each of four regions (head and neck, upper extremities, trunk, lower extremities). PASI score given represents a the percent improvement from baseline assessment. A static, or one-off, PASI (sPASI) score of 0 is equivalent to PASI100	6 months and 12 months

External Links

•   AmgenTrials clinical trials website
•   CSR Synopsis