Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (PRISTINE)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00663052
First received: April 17, 2008
Last updated: March 29, 2012
Last verified: March 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663052
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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, 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, Papulosquamous Skin Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013