Clinical Trial: Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis

Brief Summary: The primary objective is to investigate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with generalized pustular psoriasis (GPP).

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome: Proportion of subjects achieving clinical response [ Time Frame: From Week 0 to Week 16 ]

Clinical Response is defined as reduction of skin score relative to the baseline (week 0), according to Japan Dermatology Association (JDA) severity index in Generalized Pustular Psoriasis (GPP) medical care guideline 2014 in Japan.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in total GPP score [ Time Frame: From Week 2 to Week 52 ]
    Total GPP score is sum of total skin score and total systemic and laboratory test score.
  • Change in total skin score [ Time Frame: From Week 2 to Week 52 ]
    Total skin score is sum of scores of erythema (total), erythema with pustule and edema.
  • Change in Body Surface Area of each component of skin score [ Time Frame: From Week 2 to Week 52 ]
    Components of skin score are erythema (total), erythema with pustule and edema


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: August 20, 2015
Date Started: September 28, 2015
Date Completion: July 21, 2017
Last Updated: May 3, 2017
Last Verified: May 2017