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Completed

NCT Number: NCT00581100

Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail

    Time frame: Baseline, 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.

Secondary outcomes

  1. Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score

    Time frame: Baseline, 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).

  2. 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

    Time frame: Week 12, 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.

  3. 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

    Time frame: Week 12, 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.

  4. 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

    Time frame: Week 12, 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).

  5. 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

    Time frame: Week 12, 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).

  6. Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score

    Time frame: Baseline, 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).

  7. Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24

    Time frame: Week 12 , 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).

  8. Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24

    Time frame: Week 12 , 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).

  9. Change From Baseline in Physician Global Assessment (PGA) of Psoriasis

    Time frame: Baseline, Week 24

    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.

  10. Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear

    Time frame: Baseline, Week 24 or Early Termination

    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).

  11. Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better

    Time frame: Baseline, Week 24 or Early Termination

    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).

  12. Change From Baseline in the Dermatology Life Quality Index (DLQI)

    Time frame: Baseline, Week 24

    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.

  13. Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)

    Time frame: Baseline, Week 24

    Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).

  14. Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)

    Time frame: Baseline, Week 24

    Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).

  15. Change From Baseline in Physician Fingernail Grading Assessment Total Score

    Time frame: Baseline, Week 24

    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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 27, 2007
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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