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Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00581100
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : August 30, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE December 27, 2007
Results First Submitted Date  ICMJE August 3, 2010
Results First Posted Date  ICMJE August 30, 2010
Last Update Posted Date February 25, 2013
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Change from baseline in NAPSI for target fingernail over 24 weeks [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2010)
  • 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).
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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).
  • 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).
  • 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.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Change from baseline in overall NAPSI over 24 weeks [ Time Frame: 24 weeks ]
  • Proportion of subjects achieving NAPSI 50 and NAPSI 75 for target fingernail and an overall NAPSI [ Time Frame: 12 and 24 weeks ]
  • Change from baseline in the PASI [ Time Frame: 24 weeks ]
  • Proportion of subjects achieving PASI 50 and 75 [ Time Frame: 12 and 24 weeks ]
  • Change from baseline in the PGA of Psoriasis [ Time Frame: 24 weeks ]
  • Proportion of subjects achieving a status on the PGA of Psoriasis of clear or almost clear over 24 weeks [ Time Frame: 24 ]
  • Proportion of subjects achieving a status on the PGA of Psoriasis of mild or better over 24 weeks [ Time Frame: 24 weeks ]
  • Change from baseline in the Dermatology Life Quality Index (CLQI) [ Time Frame: 24 weeks ]
  • Change from baseline in the Physician and Patient Assessment of Nail Psoriasis Activity VAS [ Time Frame: 24 weeks ]
  • Change from baseline using novel assessment tool (Physician fingernail grading assessment) over 24 weeks [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nail Psoriasis
  • Plaque Psoriasis
Intervention  ICMJE Drug: etanercept

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.

Study Arms  ICMJE
  • Active Comparator: 1
    etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24
    Intervention: Drug: etanercept
  • Active Comparator: 2
    etanercept 50 mg SC once weekly for the complete 24 week treatment period
    Intervention: Drug: etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2010)
136
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
120
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581100
Other Study ID Numbers  ICMJE 0881A6-409
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP