Back to resultsEffects of Etanercept on Nail Psoriasis and Plaque Psoriasis
Primary Purpose
Nail Psoriasis, Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Nail Psoriasis focused on measuring Nail Psoriasis, Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
Active, stable plaque psoriasis defined by the following criteria:
- Body surface area (BSA) ≥ 10 % at screening and baseline
- Or, PASI >10 at screening and baseline
- Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
- Or, DLQI > 10 at baseline
- Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
- Failure of at least one systemic psoriasis therapy for nail psoriasis
- Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
Exclusion Criteria:
- Evidence of Skin conditions other than psoriasis
- Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24
etanercept 50 mg SC once weekly for the complete 24 week treatment period
Outcomes
Primary Outcome Measures
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Secondary Outcome Measures
Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
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).
Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
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).
Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
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 Physician Global Assessment (PGA) of Psoriasis
Physician Global Assessment (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.
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear
Physician Global Assessment (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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better
Physician Global Assessment (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. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.
Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Change From Baseline in Physician Fingernail Grading Assessment Total Score
Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.
Full Information
NCT ID
NCT00581100
First Posted
December 21, 2007
Last Updated
February 20, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00581100
Brief Title
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
Official Title
Randomised, Open-label Preliminary Study to Assess the Effects of 2 Regimens of Etanercept on Nail and Skin Symptoms in Patients With Nail Psoriasis and Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.
Detailed Description
This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Psoriasis, Plaque Psoriasis
Keywords
Nail Psoriasis, Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24
Arm Title
2
Arm Type
Active Comparator
Arm Description
etanercept 50 mg SC once weekly for the complete 24 week treatment period
Intervention Type
Drug
Intervention Name(s)
etanercept
Intervention Description
Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.
Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.
Primary Outcome Measure Information:
Title
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail
Description
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score
Description
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time Frame
Baseline, Week 24
Title
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Description
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.
Time Frame
Week 12, Week 24
Title
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24
Description
Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.
Time Frame
Week 12, Week 24
Title
Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
Description
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time Frame
Week 12, Week 24
Title
Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24
Description
NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).
Time Frame
Week 12, Week 24
Title
Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
Description
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).
Time Frame
Baseline, Week 24
Title
Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
Description
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).
Time Frame
Week 12 , Week 24
Title
Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
Description
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).
Time Frame
Week 12 , Week 24
Title
Change From Baseline in Physician Global Assessment (PGA) of Psoriasis
Description
Physician Global Assessment (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.
Time Frame
Baseline, Week 24
Title
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear
Description
Physician Global Assessment (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. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time Frame
Baseline, Week 24 or Early Termination
Title
Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better
Description
Physician Global Assessment (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. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).
Time Frame
Baseline, Week 24 or Early Termination
Title
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Description
Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Description
Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Time Frame
Baseline, Week 24
Title
Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
Description
Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).
Time Frame
Baseline, Week 24
Title
Change From Baseline in Physician Fingernail Grading Assessment Total Score
Description
Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Active, stable plaque psoriasis defined by the following criteria:
Body surface area (BSA) ≥ 10 % at screening and baseline
Or, PASI >10 at screening and baseline
Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
Or, DLQI > 10 at baseline
Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
Failure of at least one systemic psoriasis therapy for nail psoriasis
Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
Exclusion Criteria:
Evidence of Skin conditions other than psoriasis
Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation
Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
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Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
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