Clinical trial NCT03894956: Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
Official title: Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis Suppurativa (HS)
Humira
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 46
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hidradenitis Suppurativa (HS)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants who reported any serious infections during the study
timeFrame: Up to Week 52
measure: Percentage of participants who reported any adverse drug reactions (ADRs) during the study
timeFrame: Up to Week 52
measure: Percentage of participants who reported any infections during the study
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of participants achieving "Improved" of overall improvement by physician
timeFrame: Up to Week 52
measure: Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
timeFrame: Up to week 52
measure: Change in C-Reactive Protein (CRP)
timeFrame: From Baseline to Week 52
measure: Change in Patient's global assessment of skin pain
timeFrame: From Baseline to Week 52
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: From Baseline to Week 52
Other outcomes:
Locations:
city: Anjo-shi
country: Japan
facility: Anjou Kousei Hospital /ID# 216741
state: Aichi
city: Ichinomiya-shi
country: Japan
facility: Ichinomiya Municipal Hospital /ID# 214086
state: Aichi
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital /ID# 215312
state: Aichi
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 214406
state: Aichi
city: Nagoyashi
country: Japan
facility: Nagoya University Hospital /ID# 214135
state: Aichi
city: Kisarazu-shi
country: Japan
facility: Kimitsu Chuo Hospital /ID# 214733
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital /ID# 214090
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 214092
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137
state: Fukuoka
city: Hatsukaichi-shi
country: Japan
facility: JA Hiroshima General Hospital /ID# 213472
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Sapporo Higashi Tokushukai Hospital /ID# 213865
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital /ID# 215642
state: Hyogo
city: Kobe-shi
country: Japan
facility: Bito Dermatology Clinic /ID# 215316
state: Hyogo
city: Takarazuka-shi
country: Japan
facility: Takarazuka City Hospital /ID# 214088
state: Hyogo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital /ID# 214089
state: Ibaraki
city: Yokohama shi
country: Japan
facility: Yokohama City University Medical Center /ID# 216740
state: Kanagawa
city: Yokosuka-shi
country: Japan
facility: Yokosuka Kyosai Hospital /ID# 215310
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital /ID# 214091
state: Kochi
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 215315
state: Kyoto
city: Yokkaichi-shi
country: Japan
facility: Yokkaichi Municipal Hospital /ID# 215641
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 217830
state: Miyagi
city: Sendai-shi
country: Japan
facility: Tohoku Rosai Hospital /ID# 214084
state: Miyagi
city: Ikoma-shi
country: Japan
facility: Nara Hospital Kinki University Faculty of Medicine, /ID# 218640
state: Nara
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 215317
state: Okayama
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 214136
state: Okinawa
city: Kishiwada-shi
country: Japan
facility: Kishiwada City Hospital /ID# 213471
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 217831
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 215314
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital /ID# 214087
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital /ID# 215599
state: Saitama
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center /ID# 218639
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: JA Shizuoka Kohseiren Ensh Hospital /ID# 218160
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Shizuoka City Shizuoka Hospital /ID# 217292
state: Shizuoka
city: Minato-ku
country: Japan
facility: Toranomon Hospital /ID# 213470
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134
state: Tokyo
city: Toyama-shi
country: Japan
facility: Toyama University Hospital /ID# 214407
state: Toyama
city: Hokkaido
country: Japan
facility: Japanese Red Cross Kitami Hospital /ID# 214085
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan. J Dermatol. 2022 Apr;49(4):411-421. doi: 10.1111/1346-8138.16297. Epub 2022 Jan 17.