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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24 |
|
| 2 | Active Comparator | etanercept 50 mg SC once weekly for the complete 24 week treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
18 years of age or older
Active, stable plaque psoriasis defined by the following criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
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Eighty-five participants were screened for the study; 13 participants were screening failures, and 72 participants were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept: Twice, Then Once Weekly | Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 |
| FG001 | Etanercept: Once Weekly | Etanercept 50 mg SC once weekly for the complete 24 week treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept: Twice, Then Once Weekly | Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 |
| BG001 | Etanercept: Once Weekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 24 |
|
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Safety population: all subjects who took at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept: Twice, Then Once Weekly | Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis not otherwise specified (NOS) | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Baseline, Week 24 |
| 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. | Week 12, Week 24 |
| 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. | Week 12, Week 24 |
| 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). | Week 12, Week 24 |
| 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). | Week 12, Week 24 |
| 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). | Baseline, Week 24 |
| 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). | Week 12 , Week 24 |
| 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). | Week 12 , Week 24 |
| 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. | Baseline, Week 24 |
| 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). | Baseline, Week 24 or Early Termination |
| 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). | Baseline, Week 24 or Early Termination |
| 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. | Baseline, Week 24 |
| 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). | Baseline, Week 24 |
| 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). | Baseline, Week 24 |
| 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. | Baseline, Week 24 |
| Withdrawal by Subject |
|
| Other |
|
Etanercept 50 mg SC once weekly for the complete 24 week treatment period
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24 |
| OG001 | Etanercept: Once Weekly | Etanercept 50 mg SC once weekly for the complete 24 week treatment period |
|
|
|
| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 24 |
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| Secondary | 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. | mITT, N = number of participants with evaluable data. | Posted | Number | percent of participants | Week 12, Week 24 |
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| Secondary | 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. | mITT, N = number of participants with evaluable data. | Posted | Number | percent of participants | Week 12, Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Number | percent of participants | Week 12, Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Number | units on a scale | Week 12, Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Number | percent of participants | Week 12 , Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Number | percent of participants | Week 12 , Week 24 |
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| Secondary | 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. | mITT, N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | unts on a scale | Baseline, Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Number | percent of participants | Baseline, Week 24 or Early Termination |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Number | percent of participants | Baseline, Week 24 or Early Termination |
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| Secondary | 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. | mITT, N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 24 |
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| Secondary | 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). | mITT, N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 24 |
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| Secondary | 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. | mITT, N = number of participants with evaluable data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, Week 24 |
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|
|
|
| 2 |
| 38 |
| 22 |
| 38 |
| EG001 | Etanercept: Once Weekly | Etanercept 50 mg SC once weekly for the complete 24 week treatment period | 0 | 34 | 12 | 34 |
| Myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Conjunctivitis NEC | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperacidity | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhea NOS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sore throat NOS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site dermatitis | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Application site rash | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site burning | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Liver fatty | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory tract infection NOS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Pharyngitis NOS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Transaminase NOS increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Localized osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Localized infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Headache NOS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Burning sensation NOS | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraesthesia NEC | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pruritus NOS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Psoriasis aggravated | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin disorder NOS | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hematoma NOS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension NOS | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| <0.0001 |
Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit]. |
| 95 |
| No |
| Superiority or Other |
Week 12
| GEE model |
| <0.001 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit]. | 95 | No | Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit]. | 95 | No | Superiority or Other |
Week 12
| GEE model |
| 0.006 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
Week 12
| GEE model |
| <0.001 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit]. | 95 | No | Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit]. | 95 | No | Superiority or Other |
Week 12
| GEE model |
| 0.006 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
| <0.0001 |
Adjusted change calculated from mixed model. Model for change=[Group visit group*visit baseline baseline*visit]. |
| 95 |
| No |
| Superiority or Other |
Week 12
| GEE model |
| <0.001 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
Week 12
| GEE model |
| <0.001 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
| Week 24 | GEE model | <0.001 | P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. | 95 | No | Superiority or Other |
| <0.0001 |
Adjusted change calculated from mixed model. Model for change-[Group visit Group*visit baseline baseline*visit]. |
| 95 |
| No |
| Superiority or Other |
| <0.001 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| <0.001 |
P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit]. |
| 95 |
| No |
| Superiority or Other |
| <0.0001 |
Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit]. |
| 95 |
| No |
| Superiority or Other |
| <0.0001 |
Adjusted change calculated from mixed model. Model for change=[Group visit Group*visit baseline baseline*visit]. |
| 95 |
| No |
| Superiority or Other |
| <0.0001 |
<Table 8-14> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS) |
| 95 |
| No |
| Superiority or Other |
| <0.0001 |
Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit]. |
| 95 |
| No |
| Superiority or Other |