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The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Hidradenitis suppurativa (HS) | Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessing adverse events | Adverse event information is collected to assess prevalence of safety. | Up to 70 days following the last administration of Humira® |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Dermatology Life Quality Index (DLQI) | DLQI will be collected to evaluate effectiveness of adalimumab. DLQI has 10 quality of life domains scored from 0 (no effect) to thirty (very large effect). | Week 0 (baseline), Week 12, and Week 24 |
| Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR) |
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Inclusion Criteria:
Exclusion Criteria:
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Hidradenitis suppurativa (HS) participants who have been prescribed Adalimumab by the treating investigator as per approved label in Korea will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National Univ Hosp /ID# 162930 | Daegu | Daegu Gwang Yeogsi | 41944 | South Korea | ||
| Seoul National Univ Bundang ho /ID# 202254 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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The HiSCR measure is designed to assess treatment response in a binary manner, rather than being a continuous or ordinal scale. It includes a count of the total number of abscesses and inflammatory nodules (ANs), as well as recording the number of sinuses draining purulent fluid present in an individual. Treatment responders are defined as those who achieve at least a 50% reduction in ANs, with no increase in the number of abscesses or draining sinuses, relative to baseline. |
| Week 0 (baseline), Week 12, and Week 24 |
| Seongnam |
| Gyeonggido |
| 13620 |
| South Korea |
| CHA Bundang Medical center, CHA University /ID# 203364 | Seongnam-si | Gyeonggido | 13496 | South Korea |
| Ajou University Hospital /ID# 163243 | Suwon | Gyeonggido | 16499 | South Korea |
| Chonnam National University Hospital /ID# 162932 | Gwangju | Jeonranamdo | 61469 | South Korea |
| Yonsei University Health System, Severance Hospital /ID# 162933 | Seodaemun-gu | Seoul Teugbyeolsi | 03722 | South Korea |
| Seoul SongDo Hospital /ID# 202597 | Seoul | Seoul Teugbyeolsi | 04597 | South Korea |
| Gangnam Severance Hospital /ID# 162924 | Seoul | Seoul Teugbyeolsi | 06273 | South Korea |
| Samsung Medical Center /ID# 162934 | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| St. Mary's Hospital of the Cat /ID# 162923 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Dong-A University Hospital /ID# 162931 | Busan | 49201 | South Korea |
| Korea University Anam Hospital /ID# 162922 | Seoul | 02841 | South Korea |
| Seoul National University Hospital /ID# 162935 | Seoul | 03080 | South Korea |
| Hangyang University Medical Ce /ID# 162929 | Seoul | 04763 | South Korea |
| Konkuk University Medical Cent /ID# 162927 | Seoul | 05030 | South Korea |
| Asan Medical Center /ID# 162925 | Seoul | 05505 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital /ID# 162926 | Seoul | 07441 | South Korea |
| Ewha Womans University Mokdong /ID# 162928 | Seoul | 07985 | South Korea |
| National Medical Center /ID# 162936 | Seoul | 100-799 | South Korea |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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