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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00663052
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : April 23, 2012
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Psoriasis Drug: Etanercept Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : June 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24 [ Time Frame: 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).


Secondary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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).

  3. 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 ]
    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).

  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 ]
    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).

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

  6. Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks [ Time Frame: Baseline to Week 24 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  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 [ Time Frame: Baseline to 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.

  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 Frame: Baseline to Week 24 ]
    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).

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

  12. Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]
  13. Change From Baseline in the Photographed Image of Lesions in Selected Participants [ Time Frame: Baseline to Week 24 ]
    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.

  14. Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24 [ Time Frame: From Week 12 to 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.

  15. Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12 [ Time Frame: 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.

  16. Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24 [ Time Frame: 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.


Other Outcome Measures:
  1. Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]
    SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.

  2. Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]
    SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.

  3. Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]
    SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.

  4. Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.

  5. Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]
    Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.

  6. Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24 [ Time Frame: Baseline to Week 24 ]
    Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either 'satisfactory' or 'not satisfactory.' These are: 1) whether the participant's current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant's current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.

  7. Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) [ Time Frame: Baseline to 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) with Yes/No answers are summarized here.

  8. Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ) [ Time Frame: Baseline to 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) with Yes/No answers are summarized here.

  9. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24 [ Time Frame: Baseline to Week 24 ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).

  10. Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index [ Time Frame: Baseline, Week 12 and Week 24 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example "confined to bed"). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.

  11. Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score [ Time Frame: Baseline, Week 12 and Week 24 ]
    HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

  12. Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score [ Time Frame: Baseline, Week 12 and Week 24 ]
    HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

  13. Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12 [ Time Frame: Week 12 ]
    WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).

  14. Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24 [ Time Frame: Week 24 ]
    WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).

  15. Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12 [ Time Frame: Week 12 ]
    MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.

  16. Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24 [ Time Frame: Week 24 ]
    MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

  17. Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores [ Time Frame: Week 12 and Week 24 ]
    FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.

  18. Percentage of Participants With Emergency Room Visits [ Time Frame: Week 12 and Week 24 ]
    As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.

  19. Mean Number of Emergency Room Days [ Time Frame: Week 12 and Week 24 ]
    As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.

  20. Percentage of Participants With Doctor Visits [ Time Frame: Week 12 and Week 24 ]
    As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.

  21. Mean Number of Doctor Visits [ Time Frame: Week 12 and Week 24 ]
    As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00663052


Locations
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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, 124 62
Pfizer Investigational Site
Athens, Greece, 16121
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 TOC, Taiwan, 100
Pfizer Investigational Site
Taipei, Taiwan, 110
Thailand
Pfizer Investigational Site
Bangkok, Thailand
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00663052    
Other Study ID Numbers: 0881A6-4425
B1801013
First Posted: April 21, 2008    Key Record Dates
Results First Posted: April 23, 2012
Last Update Posted: April 23, 2012
Last Verified: March 2012
Keywords provided by Pfizer:
Enbrel
Psoriasis
Topical Psoriasis
Wyeth Psoriasis
Active Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors