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 ]
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