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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02239666
Other study ID # 20120363
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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