Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
- Conditions
- Hidradenitis Suppurativa (HS)
- Registration Number
- NCT03001115
- Lead Sponsor
- AbbVie
- Brief Summary
The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- Participant who are eligible to be treated with adalimumab for HS in accordance with the approved Korean label
- Participant must provide written authorization form to use their personal health data prior to the participating in the study.
- Participant who are contraindications to adalimumab as listed on the approved Korean label.
- Participant who is participating on other clinical trials.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessing adverse events Up to 70 days following the last administration of Humira® Adverse event information is collected to assess prevalence of safety.
- Secondary Outcome Measures
Name Time Method Change from baseline in Dermatology Life Quality Index (DLQI) Week 0 (baseline), Week 12, and Week 24 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).
Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR) Week 0 (baseline), Week 12, and Week 24 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.
Trial Locations
- Locations (19)
Kyungpook National Univ Hosp /ID# 162930
🇰🇷Daegu, Daegu Gwang Yeogsi, Korea, Republic of
Seoul National Univ Bundang ho /ID# 202254
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Ajou University Hospital /ID# 163243
🇰🇷Suwon-si, Gyeonggido, Korea, Republic of
Yonsei University Health System, Severance Hospital /ID# 162933
🇰🇷Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of
Seoul SongDo Hospital /ID# 202597
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 162934
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Gangnam Severance Hospital /ID# 162924
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Anam Hospital /ID# 162922
🇰🇷Seoul, Korea, Republic of
St. Mary's Hospital of the Cat /ID# 162923
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Dong-A University Hospital /ID# 162931
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital /ID# 162935
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Cent /ID# 162927
🇰🇷Seoul, Korea, Republic of
Hangyang University Medical Ce /ID# 162929
🇰🇷Seoul, Korea, Republic of
Asan Medical Center /ID# 162925
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong /ID# 162928
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital /ID# 162926
🇰🇷Seoul, Korea, Republic of
National Medical Center /ID# 162936
🇰🇷Seoul, Korea, Republic of
CHA Bundang Medical center, CHA University /ID# 203364
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Chonnam National University Hospital /ID# 162932
🇰🇷Gwangju, Jeonranamdo, Korea, Republic of