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. 2013 Jan 31;2013(1):CD007633. doi: 10.1002/14651858.CD007633.pub2

NCT00581100.

Trial name or 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
Methods This is an open‐label randomised controlled trial.
The study will assess the effects of the 2 etanercept regimens on fingernail psoriasis over 24 weeks among participants with both skin and fingernail involvement who have previously failed at least 1 therapy for nail psoriasis.
The end point of 24 weeks was chosen to allow sufficient time for normal nail growth.
Participants Inclusion criteria of the trial
  • Participants of 18 years of age or older with active fingernail psoriasis and failure of at least 1 systemic psoriasis therapy for nail psoriasis

Interventions
  • Etanercept

Outcomes Outcomes of the trial
  1. Change from baseline in NAPSI for target fingernail over 24 weeks

  2. Proportion of subjects achieving NAPSI 50 and NAPSI 75 for target fingernail and an overall NAPSI at 12 and 24 weeks

  3. Change from baseline in the Physician and Patient Assessment of Nail Psoriasis Activity VAS to 24 weeks

  4. Change from baseline using novel assessment tool (physician fingernail grading assessment) over 24 weeks

Starting date September 2007
Contact information Medical Monitor, Study Director, Wyeth
Notes Status: Completed