Plaque PsoriasisNCT02239666
Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis
An observational study of Plaque Psoriasis, run by AstraZeneca at 106 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- NIS
- How many people
- 899 participants
- Where
- 106 sitesin 5 countries
- Study dates
- 1 Mar 2014to 5 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- subjects who are participating in a clinical trial utilizing an investigational agent in the 3 months prior to the first biologic dose on study
Trial locations and contacts
106 sites in 5 countries.
106 sites in 5 countries
United States37 sites
Research Site
Alpharetta, Georgia, 30022
Research Site
Aurora, Colorado, 80045
Research Site
Aventura, Florida, 33180
Research Site
Bakersfield, California, 93309
Research Site
Birmingham, Alabama, 35233
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Bridgeport, West Virginia, 26330
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Burbank, California, 91505
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Carmel, Indiana, 46032
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Clarkston, Michigan, 48346
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Dallas, Texas, 75246
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East Windsor, New Jersey, 08520
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Gahanna, Ohio, 43230
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77065
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Indianapolis, Indiana, 46256
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Irvine, California, 92697
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Louisville, Kentucky, 40202
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Macon, Georgia, 31217
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New York, New York, 10016
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Norfolk, Virginia, 23502
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Overland Park, Kansas, 66215
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Owensboro, Kentucky, 42303
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Pembroke Pines, Florida, 33028
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Philadelphia, Pennsylvania, 19103
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Pittsburgh, Pennsylvania, 15213
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Portland, Oregon, 97239
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Roanoke, Virginia, 24016
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Rochester, New York, 14618
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Rogers, Arkansas, 72758
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Sacramento, California, 95819
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San Antonio, Texas, 78229
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Sandy Springs, Georgia, 30328
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Seattle, Washington, 98101
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Silver Spring, Maryland, 20902
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St Louis, Missouri, 63117
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Warren, Ohio, 44483
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West Jordan, Utah, 84088
Germany21 sites
Research Site
Bergen auf Rügen, 18528
Research Site
Berlin, 12437
Research Site
Berlin, 13055
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Berlin, 13507
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Bonn, 53105
Research Site
Buxtehude, 21614
Research Site
Dülmen, 48249
Research Site
Erlangen, 91054
Research Site
Eschweiler, 52249
Research Site
Friedrichshafen, 88045
Research Site
Gelsenkirchen-Feldmark, 45883
Research Site
Greifswald, 17489
Research Site
Hamburg, 20246
Research Site
Hamburg, 22391
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München, 81539
Research Site
Münster, 48149
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Osnabrück, 49078
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Potsdam, 14480
Research Site
Quedlinburg, 06484
Research Site
Selters, 56242
Research Site
Simmern, 55469
France17 sites
Research Site
Angers, 49933
Research Site
Argenteuil, 95107
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Besançon, 25030
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Bordeaux, 33075
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Brest, 29609
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Chambray-lès-Tours, 37170
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Le Mans, 72037
Research Site
Limoges, 87000
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Lyon, 69437
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Nice, 06200
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Pierre-Bénite, 69495
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Poitiers, 86000
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Reims, 51092
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Rennes, 35033
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Saint-Priest-en-Jarez, 42270
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Toulouse, 31059
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Vandœuvre-lès-Nancy, 54511
Italy16 sites
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Ancona, 60126
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Bergamo, 24128
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Bologna, 40138
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Brescia, 25125
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Cagliari, 09124
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Genova, 16132
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Milan, 20122
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Milan, 48018
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Modena, 41124
Research Site
Pavia, 27100
Research Site
Perugia, 06156
Research Site
Roma, 00168
Research Site
Roma (RM), 00133
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Rome, 00144
Research Site
Siena, 53100
Research Site
Verona, 37126
United Kingdom15 sites
Research Site
Airdrie, ML6 0JS
Research Site
Cardiff, CF14 4XN
Research Site
Christchurch, Dorset, BH23 2JX
Research Site
Dundee, DD1 9SY
Research Site
Durham, DH1 5TW
Research Site
Exeter, EX1 2ED
Research Site
Lincoln, LN2 4AX
Research Site
London, E11 1NR
Research Site
Nottingham, NG7 2UH
Research Site
Poole, BH15 2JB
Research Site
Portsmouth, PO3 6 AD
Research Site
Redhill, RH1 5RH
Research Site
Scunthorpe, DN15 7BH
Research Site
Stourbridge, DY8 4JB
Research Site
Wolverhampton, WV10 0QP
About this study
Official title: 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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- NIS
- Keywords
- Dermatology, plaque psoriasis, biologic treatment, biologic naive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NISOther
This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (9)
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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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).
Measured: 6 months and 12 months
PSI=0
Psoriasis Symptom Inventory (patient questionnaire) score of 0
Measured: 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).
Measured: 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).
Measured: 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
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study start1 Mar 2014
- Primary completion5 Jan 2017
- Study completion5 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Hammond, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239666
- Sponsor's protocol ID
- 20120363
- Status last verified
- Aug 2017
- First submitted
- 11 Sep 2014
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Estimate the Proportion of Subjects With Plaque Psoriasis Who Achieve Complete Clearance on Biologics
- ClinicalTrials.gov ID
- NCT02239666
- Acronym / sponsor ID
- 20120363
- Conditions
- Plaque Psoriasis
- Keywords
- Dermatology, plaque psoriasis, biologic treatment, biologic naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- 5 Jan 2017 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate to Severe Plaque Psoriasis | – | Other: NISProspective 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- subjects who are participating in a clinical trial utilizing an investigational agent in the 3 months prior to the first biologic dose on study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NISThis is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy. | Other | Moderate to Severe Plaque Psoriasis |
Primary outcome
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
9 secondary outcomes
PASI100 (or sPASI=0)
Time frame: 12 months
PASI100 (or sPASI=0)
Time frame: 6 months and 12 months
sPGA=0
Time frame: 6 months and 12 months
Psoriasis Symptom Inventory (PSI) responders
Time frame: 6 months and 12 months
sPGA=0 or 1
Time frame: 6 months and 12 months
PSI=0
Time frame: 6 months and 12 months
Dermatology Life Quality Index (DLQI) =0
Time frame: 6 months and 12 months
Static Patient Global Assessment (sPtGA)
Time frame: 6 months and 12 months
Percent PASI improvement (or sPASI scores)
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- CSR SynopsisLink provided by the sponsor.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Hammond study director
AstraZeneca
106 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by AstraZeneca at 106 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Germany, France, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI100 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.