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

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenanstalt Rudolfstiftung /ID# 166804, Vienna, State of Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of moderate to severe Hidradenitis Suppurativa
The decision to treat with adalimumab (Humira) is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the participant to participate in this study
Participants willing to be involved in the study and to sign patient authorization form to use and disclose personal health information (or informed consent, where applicable)

Exclusion criteria

Participants in a clinical interventional study
Participants treated with adalimumab prior to baseline visit

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: HARMONY

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jun 1, 2016
Registry last updated: Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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