Clinical Trial: Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the "New-Drug Re-examination

Brief Summary: The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome: Assessing adverse events [ Time Frame: Up to 70 days following the last administration of Humira® ]

Adverse event information is collected to assess prevalence of safety.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 0 (baseline), Week 12, and Week 24 ]
    The HiSCR measure is designed to assess treatment response in a binary manner, rather than being a continuous or ordinal scale. It includes a count of the total number of abscesses and inflammatory nodules (ANs), as well as recording the number of sinuses draining purulent fluid present in an individual. Treatment responders are defined as those who achieve at least a 50% reduction in ANs, with no increase in the number of abscesses or draining sinuses, relative to baseline.
  • Change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Week 0 (baseline), Week 12, and Week 24 ]
    DLQI will be collected to evaluate effectiveness of adalimumab. DLQI has 10 quality of life domains scored from 0 (no effect) to thirty (very large effect).


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: December 20, 2016
Date Started: March 10, 2017
Date Completion: March 12, 2019
Last Updated: May 12, 2017
Last Verified: May 2017