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

NCT02239666 | Completed

• 1 other identifier: 20120363
• Study Type: observational
• Target: 899
• Locations: 5 countries
• Sites: 106

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.

Conditions

Plaque Psoriasis

Keywords

Dermatology, plaque psoriasis, biologic treatment, biologic naive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• PASI100 (or sPASI=0)

  12 months

• PASI100 (or sPASI=0)

  6 months and 12 months

• sPGA=0

  6 months and 12 months

• Psoriasis Symptom Inventory (PSI) responders

  6 months and 12 months

• sPGA=0 or 1

  6 months and 12 months

Study Arms (1)

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.

Other: NIS

Interventions

NIS OTHER

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

Moderate to Severe Plaque Psoriasis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (106)

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Birmingham, Alabama, 35233, United States

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Hot Springs, Arkansas, 71913, United States

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Rogers, Arkansas, 72758, United States

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Bakersfield, California, 93309, United States

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Burbank, California, 91505, United States

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Irvine, California, 92697, United States

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Sacramento, California, 95819, United States

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Aurora, Colorado, 80045, United States

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Aventura, Florida, 33180, United States

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Pembroke Pines, Florida, 33028, United States

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Alpharetta, Georgia, 30022, United States

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Macon, Georgia, 31217, United States

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Sandy Springs, Georgia, 30328, United States

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Carmel, Indiana, 46032, United States

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Indianapolis, Indiana, 46256, United States

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Overland Park, Kansas, 66215, United States

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Louisville, Kentucky, 40202, United States

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Owensboro, Kentucky, 42303, United States

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Silver Spring, Maryland, 20902, United States

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Clarkston, Michigan, 48346, United States

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St Louis, Missouri, 63117, United States

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East Windsor, New Jersey, 08520, United States

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New York, New York, 10016, United States

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Rochester, New York, 14618, United States

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Gahanna, Ohio, 43230, United States

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Warren, Ohio, 44483, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19103, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77065, United States

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San Antonio, Texas, 78229, United States

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West Jordan, Utah, 84088, United States

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Norfolk, Virginia, 23502, United States

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Roanoke, Virginia, 24016, United States

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Seattle, Washington, 98101, United States

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Bridgeport, West Virginia, 26330, United States

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Angers, 49933, France

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Argenteuil, 95107, France

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Besançon, 25030, France

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Bordeaux, 33075, France

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Brest, 29609, France

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Chambray-lès-Tours, 37170, France

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Le Mans, 72037, France

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Limoges, 87000, France

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Lyon, 69437, France

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Nice, 06200, France

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Pierre-Bénite, 69495, France

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Poitiers, 86000, France

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Reims, 51092, France

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Rennes, 35033, France

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Saint-Priest-en-Jarez, 42270, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Bergen auf Rügen, 18528, Germany

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Berlin, 12437, Germany

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Berlin, 13055, Germany

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Berlin, 13507, Germany

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Bonn, 53105, Germany

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Buxtehude, 21614, Germany

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Dülmen, 48249, Germany

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Erlangen, 91054, Germany

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Eschweiler, 52249, Germany

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Friedrichshafen, 88045, Germany

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Gelsenkirchen-Feldmark, 45883, Germany

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Greifswald, 17489, Germany

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Hamburg, 20246, Germany

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Hamburg, 22391, Germany

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München, 81539, Germany

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Münster, 48149, Germany

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Osnabrück, 49078, Germany

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Potsdam, 14480, Germany

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Quedlinburg, 06484, Germany

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Selters, 56242, Germany

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Simmern, 55469, Germany

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Ancona, 60126, Italy

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Bergamo, 24128, Italy

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Bologna, 40138, Italy

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Brescia, 25125, Italy

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Cagliari, 09124, Italy

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Genova, 16132, Italy

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Milan, 20122, Italy

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Milan, 48018, Italy

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Modena, 41124, Italy

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Pavia, 27100, Italy

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Perugia, 06156, Italy

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Roma, 00168, Italy

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Roma (RM), 00133, Italy

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Rome, 00144, Italy

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Siena, 53100, Italy

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Verona, 37126, Italy

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Airdrie, ML6 0JS, United Kingdom

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Cardiff, CF14 4XN, United Kingdom

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Christchurch, Dorset, BH23 2JX, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Durham, DH1 5TW, United Kingdom

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Exeter, EX1 2ED, United Kingdom

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Lincoln, LN2 4AX, United Kingdom

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London, E11 1NR, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Poole, BH15 2JB, United Kingdom

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Portsmouth, PO3 6 AD, United Kingdom

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Redhill, RH1 5RH, United Kingdom

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Scunthorpe, DN15 7BH, United Kingdom

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Stourbridge, DY8 4JB, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Links

• AmgenTrials clinical trials website
• CSR Synopsis

Study Officials

• Edward Hammond

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: March 1, 2014
• Primary Completion: January 5, 2017
• Study Completion: January 5, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

IT (16); GB (15); DE (21); US (37); FR (17)