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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.
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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIS | Other | This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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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
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| Name | Affiliation | Role |
|---|---|---|
| Edward Hammond | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35233 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
| CSR Synopsis | View source |
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| 12 months |
| 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 |
| 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 |
| 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 |
| 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 |
| PSI=0 | Psoriasis Symptom Inventory (patient questionnaire) score of 0 | 6 months and 12 months |
| 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 |
| 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 |
| 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 |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Research Site | Rogers | Arkansas | 72758 | United States |
| Research Site | Bakersfield | California | 93309 | United States |
| Research Site | Burbank | California | 91505 | United States |
| Research Site | Irvine | California | 92697 | United States |
| Research Site | Sacramento | California | 95819 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Aventura | Florida | 33180 | United States |
| Research Site | Pembroke Pines | Florida | 33028 | United States |
| Research Site | Alpharetta | Georgia | 30022 | United States |
| Research Site | Macon | Georgia | 31217 | United States |
| Research Site | Sandy Springs | Georgia | 30328 | United States |
| Research Site | Carmel | Indiana | 46032 | United States |
| Research Site | Indianapolis | Indiana | 46256 | United States |
| Research Site | Overland Park | Kansas | 66215 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Owensboro | Kentucky | 42303 | United States |
| Research Site | Silver Spring | Maryland | 20902 | United States |
| Research Site | Clarkston | Michigan | 48346 | United States |
| Research Site | St Louis | Missouri | 63117 | United States |
| Research Site | East Windsor | New Jersey | 08520 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | Rochester | New York | 14618 | United States |
| Research Site | Gahanna | Ohio | 43230 | United States |
| Research Site | Warren | Ohio | 44483 | United States |
| Research Site | Portland | Oregon | 97239 | United States |
| Research Site | Philadelphia | Pennsylvania | 19103 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Houston | Texas | 77065 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | West Jordan | Utah | 84088 | United States |
| Research Site | Norfolk | Virginia | 23502 | United States |
| Research Site | Roanoke | Virginia | 24016 | United States |
| Research Site | Seattle | Washington | 98101 | United States |
| Research Site | Bridgeport | West Virginia | 26330 | United States |
| Research Site | Angers | 49933 | France |
| Research Site | Argenteuil | 95107 | France |
| Research Site | Besançon | 25030 | France |
| Research Site | Bordeaux | 33075 | France |
| Research Site | Brest | 29609 | France |
| Research Site | Chambray-lès-Tours | 37170 | France |
| Research Site | Le Mans | 72037 | France |
| Research Site | Limoges | 87000 | France |
| Research Site | Lyon | 69437 | France |
| Research Site | Nice | 06200 | France |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Poitiers | 86000 | France |
| Research Site | Reims | 51092 | France |
| Research Site | Rennes | 35033 | France |
| Research Site | Saint-Priest-en-Jarez | 42270 | France |
| Research Site | Toulouse | 31059 | France |
| Research Site | Vandœuvre-lès-Nancy | 54511 | France |
| Research Site | Bergen auf Rügen | 18528 | Germany |
| Research Site | Berlin | 12437 | Germany |
| Research Site | Berlin | 13055 | Germany |
| Research Site | Berlin | 13507 | Germany |
| Research Site | Bonn | 53105 | Germany |
| Research Site | Buxtehude | 21614 | Germany |
| Research Site | Dülmen | 48249 | Germany |
| Research Site | Erlangen | 91054 | Germany |
| Research Site | Eschweiler | 52249 | Germany |
| Research Site | Friedrichshafen | 88045 | Germany |
| Research Site | Gelsenkirchen-Feldmark | 45883 | Germany |
| Research Site | Greifswald | 17489 | Germany |
| Research Site | Hamburg | 20246 | Germany |
| Research Site | Hamburg | 22391 | Germany |
| Research Site | München | 81539 | Germany |
| Research Site | Münster | 48149 | Germany |
| Research Site | Osnabrück | 49078 | Germany |
| Research Site | Potsdam | 14480 | Germany |
| Research Site | Quedlinburg | 06484 | Germany |
| Research Site | Selters | 56242 | Germany |
| Research Site | Simmern | 55469 | Germany |
| Research Site | Ancona | 60126 | Italy |
| Research Site | Bergamo | 24128 | Italy |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Brescia | 25125 | Italy |
| Research Site | Cagliari | 09124 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Milan | 20122 | Italy |
| Research Site | Milan | 48018 | Italy |
| Research Site | Modena | 41124 | Italy |
| Research Site | Pavia | 27100 | Italy |
| Research Site | Perugia | 06156 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Roma (RM) | 00133 | Italy |
| Research Site | Rome | 00144 | Italy |
| Research Site | Siena | 53100 | Italy |
| Research Site | Verona | 37126 | Italy |
| Research Site | Airdrie | ML6 0JS | United Kingdom |
| Research Site | Cardiff | CF14 4XN | United Kingdom |
| Research Site | Christchurch, Dorset | BH23 2JX | United Kingdom |
| Research Site | Dundee | DD1 9SY | United Kingdom |
| Research Site | Durham | DH1 5TW | United Kingdom |
| Research Site | Exeter | EX1 2ED | United Kingdom |
| Research Site | Lincoln | LN2 4AX | United Kingdom |
| Research Site | London | E11 1NR | United Kingdom |
| Research Site | Nottingham | NG7 2UH | United Kingdom |
| Research Site | Poole | BH15 2JB | United Kingdom |
| Research Site | Portsmouth | PO3 6 AD | United Kingdom |
| Research Site | Redhill | RH1 5RH | United Kingdom |
| Research Site | Scunthorpe | DN15 7BH | United Kingdom |
| Research Site | Stourbridge | DY8 4JB | United Kingdom |
| Research Site | Wolverhampton | WV10 0QP | United Kingdom |