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

August 2, 2017 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

899

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Research Site
      • Argenteuil, France, 95107
        • Research Site
      • Besancon Cedex, France, 25030
        • Research Site
      • Bordeaux, France, 33075
        • Research Site
      • Brest Cedex, France, 29609
        • Research Site
      • Chambray les Tours, France, 37170
        • Research Site
      • Le Mans Cedex 9, France, 72037
        • Research Site
      • Limoges, France, 87000
        • Research Site
      • Lyon Cedex 03, France, 69437
        • Research Site
      • Nice, France, 06200
        • Research Site
      • Pierre-Benite cedex, France, 69495
        • Research Site
      • Poitiers, France, 86000
        • Research Site
      • Reims cedex, France, 51092
        • Research Site
      • Rennes Cedex 9, France, 35033
        • Research Site
      • Saint Priest en Jarez, France, 42270
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
      • Vandoeuvre les Nancy, France, 54511
        • Research Site
  • Germany
      • Bergen auf Rügen, Germany, 18528
        • Research Site
      • Berlin, Germany, 13055
        • Research Site
      • Berlin, Germany, 13507
        • Research Site
      • Berlin, Germany, 12437
        • Research Site
      • Bonn, Germany, 53105
        • Research Site
      • Buxtehude, Germany, 21614
        • Research Site
      • Dülmen, Germany, 48249
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Eschweiler, Germany, 52249
        • Research Site
      • Friedrichshafen, Germany, 88045
        • Research Site
      • Gelsenkirchen-Feldmark, Germany, 45883
        • Research Site
      • Greifswald, Germany, 17489
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Hamburg, Germany, 22391
        • Research Site
      • München, Germany, 81539
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Osnabrück, Germany, 49078
        • Research Site
      • Potsdam, Germany, 14480
        • Research Site
      • Quedlinburg, Germany, 06484
        • Research Site
      • Selters, Germany, 56242
        • Research Site
      • Simmern, Germany, 55469
        • Research Site
  • Italy
      • Ancona, Italy, 60126
        • Research Site
      • Bergamo, Italy, 24128
        • Research Site
      • Bologna, Italy, 40138
        • Research Site
      • Brescia, Italy, 25125
        • Research Site
      • Cagliari, Italy, 09124
        • Research Site
      • Genova, Italy, 16132
        • Research Site
      • Milano, Italy, 20122
        • Research Site
      • Milano, Italy, 48018
        • Research Site
      • Modena, Italy, 41124
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Perugia, Italy, 06156
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Roma (RM), Italy, 00133
        • Research Site
      • Rome, Italy, 00144
        • Research Site
      • Siena, Italy, 53100
        • Research Site
      • Verona, Italy, 37126
        • Research Site
  • United Kingdom
      • Airdrie, United Kingdom, ML6 0JS
        • Research Site
      • Cardiff, United Kingdom, CF14 4XN
        • Research Site
      • Christchurch, Dorset, United Kingdom, BH23 2JX
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • Durham, United Kingdom, DH1 5TW
        • Research Site
      • Exeter, United Kingdom, EX1 2ED
        • Research Site
      • Lincoln, United Kingdom, LN2 4AX
        • Research Site
      • London, United Kingdom, E11 1NR
        • Research Site
      • Nottingham, United Kingdom, NG7 2UH
        • Research Site
      • Poole, United Kingdom, BH15 2JB
        • Research Site
      • Portsmouth, United Kingdom, PO3 6 AD
        • Research Site
      • Redhill, United Kingdom, RH1 5RH
        • Research Site
      • Scunthorpe, United Kingdom, DN15 7BH
        • Research Site
      • Stourbridge, United Kingdom, DY8 4JB
        • Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Research Site
      • Rogers, Arkansas, United States, 72758
        • Research Site
    • California
      • Bakersfield, California, United States, 93309
        • Research Site
      • Burbank, California, United States, 91505
        • Research Site
      • Irvine, California, United States, 92697
        • Research Site
      • Sacramento, California, United States, 95819
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Research Site
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Research Site
      • Macon, Georgia, United States, 31217
        • Research Site
      • Sandy Springs, Georgia, United States, 30328
        • Research Site
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Research Site
      • Indianapolis, Indiana, United States, 46256
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
      • Owensboro, Kentucky, United States, 42303
        • Research Site
    • Maryland
      • Silver Spring, Maryland, United States, 20902
        • Research Site
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Research Site
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
      • Rochester, New York, United States, 14618
        • Research Site
    • Ohio
      • Gahanna, Ohio, United States, 43230
        • Research Site
      • Warren, Ohio, United States, 44483
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Research Site
      • Houston, Texas, United States, 77065
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Roanoke, Virginia, United States, 24016
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Research Site
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASI100
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASI100 (or sPASI=0)
Time Frame: 12 months
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
PASI100 (or sPASI=0)
Time Frame: 6 months and 12 months
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
Time Frame: 6 months and 12 months
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
Time Frame: 6 months and 12 months
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
Time Frame: 6 months and 12 months
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
Time Frame: 6 months and 12 months
Psoriasis Symptom Inventory (patient questionnaire) score of 0
6 months and 12 months
Dermatology Life Quality Index (DLQI) =0
Time Frame: 6 months and 12 months
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)
Time Frame: 6 months and 12 months
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)
Time Frame: 6 months and 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Edward Hammond, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

January 5, 2017

Study Completion (Actual)

January 5, 2017

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120363

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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