Hidradenitis Suppurativa
Conditions
Keywords
Moderate to Severe Hidradenitis Suppurativa, Adalimumab
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response | At Week 12 | Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with moderate to severe HS who achieve a clinical response | 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) | 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. |
Countries
Austria, Belgium, Czechia, Germany, Greece, Hungary, Ireland, Israel, Lebanon, Slovenia, Switzerland, Turkey (Türkiye), United Kingdom
Outcome results
None listed