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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hidradenitis Suppurativa

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving adalimumab<br>Hidradenitis Suppurativa (HS) participants receiving adalimumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response | Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR) | At Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with moderate to severe HS who achieve a clinical response | Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR) | Up to week 52 | 
| Changes from baseline in Dermatology Quality of Life Index (DLQI) | 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. | From Week 0 to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to Severe Hidradenitis Suppurativa, Adalimumab