Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa (HS)
- Registration Number
- NCT03894956
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS.
- Participants previously treated with Humira.
- Participants who do not provide consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants who reported any adverse drug reactions (ADRs) during the study Up to Week 52 ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Percentage of participants who reported any serious infections during the study Up to Week 52 Percentage of participants with incidence of serious infections are reported.
Percentage of participants who reported any infections during the study Up to Week 52 Percentage of participants with incidence of infections are reported.
- Secondary Outcome Measures
Name Time Method Change in C-Reactive Protein (CRP) From Baseline to Week 52 CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation.
Percentage of participants achieving "Improved" of overall improvement by physician Up to Week 52 Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician.
Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 52 DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life.
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) Up to week 52 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.
Change in Patient's global assessment of skin pain From Baseline to Week 52 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."
Trial Locations
- Locations (37)
Anjou Kousei Hospital /ID# 216741
🇯🇵Anjo-shi, Aichi, Japan
Kimitsu Chuo Hospital /ID# 214733
🇯🇵Kisarazu-shi, Chiba, Japan
NHO Nagoya Medical Center /ID# 214406
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya University Hospital /ID# 214135
🇯🇵Nagoyashi, Aichi, Japan
Ehime University Hospital /ID# 214090
🇯🇵Toon-shi, Ehime, Japan
Kyushu University Hospital /ID# 214092
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137
🇯🇵Kitakyushu-shi, Fukuoka, Japan
JA Hiroshima General Hospital /ID# 213472
🇯🇵Hatsukaichi-shi, Hiroshima, Japan
Sapporo Higashi Tokushukai Hospital /ID# 213865
🇯🇵Sapporo-shi, Hokkaido, Japan
Kobe University Hospital /ID# 215642
🇯🇵Kobe-shi, Hyogo, Japan
Takarazuka City Hospital /ID# 214088
🇯🇵Takarazuka-shi, Hyogo, Japan
Yokosuka Kyosai Hospital /ID# 215310
🇯🇵Yokosuka-shi, Kanagawa, Japan
Mito Kyodo General Hospital /ID# 214089
🇯🇵Mito-shi, Ibaraki, Japan
Yokohama City University Medical Center /ID# 216740
🇯🇵Yokohama shi, Kanagawa, Japan
Kochi Medical School Hospital /ID# 214091
🇯🇵Nankoku-shi, Kochi, Japan
Yokkaichi Municipal Hospital /ID# 215641
🇯🇵Yokkaichi-shi, Mie, Japan
University of the Ryukyus Hospital /ID# 214136
🇯🇵Nakagami-gun, Okinawa, Japan
Okayama University Hospital /ID# 215317
🇯🇵Okayama-shi, Okayama, Japan
Kishiwada City Hospital /ID# 213471
🇯🇵Kishiwada-shi, Osaka, Japan
Kindai University Hospital /ID# 217831
🇯🇵Osakasayama-shi, Osaka, Japan
Saitama Medical Center /ID# 218639
🇯🇵Kawagoe-shi, Saitama, Japan
JA Shizuoka Kohseiren Ensh Hospital /ID# 218160
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Shizuoka City Shizuoka Hospital /ID# 217292
🇯🇵Shizuoka-shi, Shizuoka, Japan
Toranomon Hospital /ID# 213470
🇯🇵Minato-ku, Tokyo, Japan
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134
🇯🇵Shinjuku-ku, Tokyo, Japan
Japanese Red Cross Kitami Hospital /ID# 214085
🇯🇵Hokkaido, Japan
Toyama University Hospital /ID# 214407
🇯🇵Toyama-shi, Toyama, Japan
Ichinomiya Municipal Hospital /ID# 214086
🇯🇵Ichinomiya-shi, Aichi, Japan
Aichi Medical University Hospital /ID# 215312
🇯🇵Nagakute-shi, Aichi, Japan
Kyoto University Hospital /ID# 215315
🇯🇵Kyoto-shi, Kyoto, Japan
Bito Dermatology Clinic /ID# 215316
🇯🇵Kobe-shi, Hyogo, Japan
Tohoku University Hospital /ID# 217830
🇯🇵Sendai-shi, Miyagi, Japan
Nara Hospital Kinki University Faculty of Medicine, /ID# 218640
🇯🇵Ikoma-shi, Nara, Japan
Tohoku Rosai Hospital /ID# 214084
🇯🇵Sendai-shi, Miyagi, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 214087
🇯🇵Takatsuki-shi, Osaka, Japan
Saitama Medical University Hospital /ID# 215599
🇯🇵Iruma-gun, Saitama, Japan
Osaka University Hospital /ID# 215314
🇯🇵Suita-shi, Osaka, Japan