Clinical trial NCT00581100: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nail Psoriasis
Plaque Psoriasis
Keywords: Nail Psoriasis
Plaque Psoriasis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score
timeFrame: Baseline, Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: 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
timeFrame: Week 12, Week 24
measure: Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline, Week 24
measure: Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
timeFrame: Week 12 , Week 24
measure: Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24
timeFrame: Week 12 , Week 24
measure: Change From Baseline in Physician Global Assessment (PGA) of Psoriasis
timeFrame: Baseline, Week 24
measure: Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear
timeFrame: Baseline, Week 24 or Early Termination
measure: Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better
timeFrame: Baseline, Week 24 or Early Termination
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, Week 24
measure: Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
timeFrame: Baseline, Week 24
measure: Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)
timeFrame: Baseline, Week 24
measure: Change From Baseline in Physician Fingernail Grading Assessment Total Score
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: