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

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ClinicalTrials.gov Identifier: NCT02239666
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment
Plaque Psoriasis Other: NIS

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.


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Study Type : Observational
Actual Enrollment : 899 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : January 5, 2017
Actual Study Completion Date : January 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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).

  4. 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

  5. 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. PSI=0 [ Time Frame: 6 months and 12 months ]
    Psoriasis Symptom Inventory (patient questionnaire) score of 0

  7. 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).

  8. 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).

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239666


  Show 106 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Edward Hammond AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02239666     History of Changes
Other Study ID Numbers: 20120363
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Keywords provided by AstraZeneca:
Dermatology, plaque psoriasis, biologic treatment, biologic naive
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases