Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (PRISTINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00663052
First received: April 17, 2008
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Psoriasis
Drug: Etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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).

  • Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • 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 Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in the Photographed Image of Lesions in Selected Participants [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 [ Time Frame: From Week 12 to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 273
Study Start Date: June 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
A
Drug: Etanercept
ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks.
Experimental: Group B
B
Drug: Etanercept
ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663052

  Hide Study Locations
Locations
Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, 01114
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, 01199
Pfizer Investigational Site
San Miguel, Buenos Aires, Argentina, 1684
Austria
Pfizer Investigational Site
Feldkirch, Austria
Pfizer Investigational Site
Wien, Austria, 1030
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1200
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Liege, Belgium, 4020
Czech Republic
Pfizer Investigational Site
Jihlava, Czech Republic, 586 33
Pfizer Investigational Site
Ostrava- Poruba, Czech Republic, 708 00
Pfizer Investigational Site
Plzen-Bory, Czech Republic, 305 99
Germany
Pfizer Investigational Site
Bochum, Germany, 44791
Pfizer Investigational Site
Erlangen, Germany, 91052
Pfizer Investigational Site
Frankfurt am Main, Germany, 60590
Pfizer Investigational Site
Hamburg, Germany, 20246
Pfizer Investigational Site
Kiel, Germany, 24105
Pfizer Investigational Site
Muenchen, Germany, 80802
Pfizer Investigational Site
Osnabrueck, Germany, 49078
Greece
Pfizer Investigational Site
Athens, Greece, 16121
Pfizer Investigational Site
Athens, Greece, 124 62
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1085
Pfizer Investigational Site
Debrecen, Hungary, 4012
Pfizer Investigational Site
Miskolc, Hungary, 3529
Pfizer Investigational Site
Szeged, Hungary, 6720
Italy
Pfizer Investigational Site
Catanzaro, Italy, 88110
Pfizer Investigational Site
L'Aquila, Italy, 67100
Korea, Republic of
Pfizer Investigational Site
Gangnam-gu, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Mexico
Pfizer Investigational Site
Zapopan, Jalisco, Mexico, 45190
Pfizer Investigational Site
Monterrey, Nuevo Leon / Mexico, Mexico, 64020
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64710
Spain
Pfizer Investigational Site
Santiago de Compostela, La Coruña, Spain, 15706
Pfizer Investigational Site
Fuenlabrada, Madrid, Spain, 28942
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Valencia, Spain, 46014
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 110
Pfizer Investigational Site
Taipei TOC, Taiwan, 100
Thailand
Pfizer Investigational Site
Bangkok, Thailand
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00663052     History of Changes
Other Study ID Numbers: 0881A6-4425, B1801013
Study First Received: April 17, 2008
Results First Received: January 18, 2011
Last Updated: March 29, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal

Keywords provided by Pfizer:
Enbrel
Psoriasis
Topical Psoriasis
Wyeth Psoriasis
Active Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Immunoglobulin G
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014