Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa

Study Overview
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Brief Summary
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The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.

Official Title
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Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa (HS)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS. Exclusion Criteria: Participants previously treated with Humira. Participants who do not provide consent.

Ages Eligible for Study
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Minimum Age: 0 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 with Hidradenitis Suppurativa (HS)<br>Participants who along with their treating physician have elected for treatment with Humira as per routine clinical practice for the treatment of HS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who reported any serious infections during the study | Percentage of participants with incidence of serious infections are reported. | Up to Week 52 | 
| Percentage of participants who reported any adverse drug reactions (ADRs) during the study | ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary. | Up to Week 52 | 
| Percentage of participants who reported any infections during the study | Percentage of participants with incidence of infections are reported. | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving Improved of overall improvement by physician | Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician. | Up to Week 52 | 
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) | HiSCR is defined as at least 50% reduction in the number of abscesses and inflammatory nodules and no increase in abscess count and no increase in draining fistula count relative to baseline. | Up to week 52 | 
| Change in C-Reactive Protein (CRP) | CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation. | From Baseline to Week 52 | 
| Change in Patient's global assessment of skin pain | Patient's global assessment of skin pain is evaluated on a 11-point scale with 0 for no pain and 10 for worst skin pain imaginable. | From Baseline to Week 52 | 
| Change in Dermatology Life Quality Index (DLQI) | DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life. | From Baseline to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis Suppurativa (HS), Humira, Adalimumab