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Plaque PsoriasisPhase 4PRISTINENCT00663052

Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis

A Phase 4 study testing Etanercept in people with Plaque Psoriasis and Psoriasis, run by Pfizer at 38 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis, Psoriasis
What is being tested?
Etanercept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
38 sitesin 13 countries
Study dates
Jun 2008to Jan 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older at time of consent.
  • Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 10.
  • In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine and psoralen plus ultraviolet A radiation (PUVA) therapy.

Who cannot join

  • Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
  • Active or recent (within 2 years) tuberculosis (TB) infection.

Trial locations and contacts

38 sites in 13 countries.

38 sites in 13 countries

Germany7 sites
  • Pfizer Investigational Site

    Bochum, 44791

  • Pfizer Investigational Site

    Erlangen, 91052

  • Pfizer Investigational Site

    Frankfurt am Main, 60590

  • Pfizer Investigational Site

    Hamburg, 20246

  • Pfizer Investigational Site

    Kiel, 24105

  • Pfizer Investigational Site

    München, 80802

  • Pfizer Investigational Site

    Osnabrück, 49078

Other trials in Germany

Hungary4 sites
  • Pfizer Investigational Site

    Budapest, 1085

  • Pfizer Investigational Site

    Debrecen, 4012

  • Pfizer Investigational Site

    Miskolc, 3529

  • Pfizer Investigational Site

    Szeged, 6720

Other trials in Hungary

Spain4 sites
  • Pfizer Investigational Site

    Barcelona, Barcelona, 08025

  • Pfizer Investigational Site

    Fuenlabrada, Madrid, 28942

  • Pfizer Investigational Site

    Santiago de Compostela, La Coruña, 15706

  • Pfizer Investigational Site

    Valencia, 46014

Other trials in Spain

Argentina3 sites
  • Pfizer Investigational Site

    Capital Federal, Buenos Aires, 01114

  • Pfizer Investigational Site

    Capital Federal, Buenos Aires, 01199

  • Pfizer Investigational Site

    San Miguel, Buenos Aires, 1684

Other trials in Argentina

Belgium3 sites
  • Pfizer Investigational Site

    Brussels, Belgium, B-1200

  • Pfizer Investigational Site

    Ghent, 9000

  • Pfizer Investigational Site

    Liège, 4020

Other trials in Belgium

Czechia3 sites
  • Pfizer Investigational Site

    Jihlava, 586 33

  • Pfizer Investigational Site

    Ostrava- Poruba, 708 00

  • Pfizer Investigational Site

    Plzen-Bory, 305 99

Other trials in Czechia

Mexico3 sites
  • Pfizer Investigational Site

    Monterrey, Nuevo Leon / Mexico, 64020

  • Pfizer Investigational Site

    Monterrey, Nuevo León, 64710

  • Pfizer Investigational Site

    Zapopan, Jalisco, 45190

Other trials in Mexico

Austria2 sites
  • Pfizer Investigational Site

    Feldkirch

  • Pfizer Investigational Site

    Vienna, 1030

Other trials in Austria

Greece2 sites
  • Pfizer Investigational Site

    Athens, 124 62

  • Pfizer Investigational Site

    Athens, 16121

Other trials in Greece

Italy2 sites
  • Pfizer Investigational Site

    Catanzaro, 88110

  • Pfizer Investigational Site

    L’Aquila, 67100

Other trials in Italy

South Korea2 sites
  • Pfizer Investigational Site

    Gangnam-gu, 135-710

  • Pfizer Investigational Site

    Seoul, 110-744

Other trials in South Korea

Taiwan2 sites
  • Pfizer Investigational Site

    Taipei, 110

  • Pfizer Investigational Site

    Taipei TOC, 100

Other trials in Taiwan

Thailand1 site
  • Pfizer Investigational Site

    Bangkok

Other trials in Thailand

About this study

Official title: A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Etanercept 50 mg Twice Weekly and Etanercept 50 mg Once Weekly for the Treatment of Moderate to Severe Psoriasis

The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.

Being tested
Etanercept
Keywords
Enbrel, Psoriasis, Topical Psoriasis, Wyeth Psoriasis, Active Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptDrug

    ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.

  • EtanerceptDrug

    ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.

Study groups in NCT00663052
Study groupRoleWhat they receive
Group AExperimentalA
Receives: Drug: Etanercept
Group BExperimentalB
Receives: Drug: Etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24

    PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Week 24

Secondary outcomes (16)
  1. Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

    PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Baseline to Week 24

  2. Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

    PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Baseline to Week 24

  3. Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

    PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Baseline to week 24

  4. Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

    PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Baseline to Week 24

  5. Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24

    PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

    Measured: Baseline to Week 24

  6. Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks

    Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100*(baseline score - visit score)/baseline score.

    Measured: Baseline to Week 24

  7. Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24

    PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear.

    Measured: Baseline to Week 24

  8. Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24

    PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear.

    Measured: Baseline to Week 24

  9. Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24

    PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.

    Measured: Baseline to Week 24

  10. Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks

    Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).

    Measured: Baseline to Week 24

  11. Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24

    PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.

    Measured: Baseline to Week 24

  12. Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24

    Measured: Baseline to Week 24

  13. Change From Baseline in the Photographed Image of Lesions in Selected Participants

    Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change.

    Measured: Baseline to Week 24

  14. Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24

    Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.

    Measured: From Week 12 to Week 24

  15. Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12

    PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.

    Measured: Week 12

  16. Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24

    PSSQ: participant's assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00663052
Sponsor's protocol ID
0881A6-4425
Other IDs
B1801013
Acronym
PRISTINE
Status last verified
Mar 2012
First submitted
17 Apr 2008
Last updated
23 Apr 2012
Data monitoring committee
No

Publications

  • Kemeny L, Amaya M, Cetkovska P, Rajatanavin N, Lee WR, Szumski A, Marshall L, Mahgoub EY, Aldinc E. Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial. BMC Dermatol. 2015 May 21;15:9. doi: 10.1186/s12895-015-0028-8.

    PubMed 25994179
  • Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.

    PubMed 25913550

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Etanercept in people with Plaque Psoriasis and Psoriasis, run by Pfizer at 38 sites in 13 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 3 inclusion and 3 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Germany, Hungary, Spain, Argentina, Belgium and 8 more countries. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00663052, which also lists 2 linked publications.

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 23 Apr 2012.

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