- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581100
Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24
|
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. |
Active Comparator: 2
etanercept 50 mg SC once weekly for the complete 24 week treatment period
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
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.
|
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
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.
|
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
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).
|
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
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).
|
Week 12, Week 24
|
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).
|
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
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).
|
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
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).
|
Week 12 , Week 24
|
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.
|
Baseline, Week 24
|
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).
|
Baseline, Week 24 or Early Termination
|
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).
|
Baseline, Week 24 or Early Termination
|
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.
|
Baseline, Week 24
|
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).
|
Baseline, Week 24
|
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).
|
Baseline, Week 24
|
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.
|
Baseline, Week 24
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- 0881A6-409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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