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

Hidradenitis Suppurativa (HS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894956
• Other study ID #: P18-835
• Status: Completed
• Start date: May 2, 2019
• Est. completion date: November 10, 2021

Study information

• Verified date: November 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Locations

Country	Name	City	State
Japan	Anjou Kousei Hospital /ID# 216741	Anjo-shi	Aichi
Japan	Kyushu University Hospital /ID# 214092	Fukuoka-shi	Fukuoka
Japan	JA Shizuoka Kohseiren Ensh Hospital /ID# 218160	Hamamatsu-shi	Shizuoka
Japan	JA Hiroshima General Hospital /ID# 213472	Hatsukaichi-shi	Hiroshima
Japan	Japanese Red Cross Kitami Hospital /ID# 214085	Hokkaido
Japan	Ichinomiya Municipal Hospital /ID# 214086	Ichinomiya-shi	Aichi
Japan	Nara Hospital Kinki University Faculty of Medicine, /ID# 218640	Ikoma-shi	Nara
Japan	Saitama Medical University Hospital /ID# 215599	Iruma-gun	Saitama
Japan	Saitama Medical Center /ID# 218639	Kawagoe-shi	Saitama
Japan	Kimitsu Chuo Hospital /ID# 214733	Kisarazu-shi	Chiba
Japan	Kishiwada City Hospital /ID# 213471	Kishiwada-shi	Osaka
Japan	Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137	Kitakyushu-shi	Fukuoka
Japan	Bito Dermatology Clinic /ID# 215316	Kobe-shi	Hyogo
Japan	Kobe University Hospital /ID# 215642	Kobe-shi	Hyogo
Japan	Kyoto University Hospital /ID# 215315	Kyoto-shi	Kyoto
Japan	Toranomon Hospital /ID# 213470	Minato-ku	Tokyo
Japan	Mito Kyodo General Hospital /ID# 214089	Mito-shi	Ibaraki
Japan	Aichi Medical University Hospital /ID# 215312	Nagakute-shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 214406	Nagoya-shi	Aichi
Japan	Nagoya University Hospital /ID# 214135	Nagoyashi	Aichi
Japan	University of the Ryukyus Hospital /ID# 214136	Nakagami-gun	Okinawa
Japan	Kochi Medical School Hospital /ID# 214091	Nankoku-shi	Kochi
Japan	Okayama University Hospital /ID# 215317	Okayama-shi	Okayama
Japan	Kindai University Hospital /ID# 217831	Osakasayama-shi	Osaka
Japan	Sapporo Higashi Tokushukai Hospital /ID# 213865	Sapporo-shi	Hokkaido
Japan	Tohoku Rosai Hospital /ID# 214084	Sendai-shi	Miyagi
Japan	Tohoku University Hospital /ID# 217830	Sendai-shi	Miyagi
Japan	Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134	Shinjuku-ku	Tokyo
Japan	Shizuoka City Shizuoka Hospital /ID# 217292	Shizuoka-shi	Shizuoka
Japan	Osaka University Hospital /ID# 215314	Suita-shi	Osaka
Japan	Takarazuka City Hospital /ID# 214088	Takarazuka-shi	Hyogo
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 214087	Takatsuki-shi	Osaka
Japan	Ehime University Hospital /ID# 214090	Toon-shi	Ehime
Japan	Toyama University Hospital /ID# 214407	Toyama-shi	Toyama
Japan	Yokkaichi Municipal Hospital /ID# 215641	Yokkaichi-shi	Mie
Japan	Yokohama City University Medical Center /ID# 216740	Yokohama shi	Kanagawa
Japan	Yokosuka Kyosai Hospital /ID# 215310	Yokosuka-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percentage of participants who reported any infections during the study	Percentage of participants with incidence of infections are reported.	Up to Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis