Clinical Trial: Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting

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

Official Title: Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting - HARMONY Study

Brief Summary: This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this study are to estimate the effectiveness of adalimumab treatment on disease severity, to estimate the impact of adalimumab treatment on patients' quality of life, psychological effect, work productivity and healthcare resource utilization and to describe treatment practices over the study period.

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome: Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response [ Time Frame: At Week 12 ]

Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of participants with moderate to severe HS who achieve a clinical response [ Time Frame: Up to week 52 ]
    Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)
  • Changes from baseline in Dermatology Quality of Life Index (DLQI) [ Time Frame: From Week 0 to Week 52 ]
    Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: May 26, 2016
Date Started: July 10, 2016
Date Completion: July 5, 2019
Last Updated: May 8, 2017
Last Verified: May 2017