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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03894956
Other study ID # P18-835
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
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Completed NCT01468233 - Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa Phase 3
Completed NCT01468207 - Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa Phase 3
Completed NCT03001115 - Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
Not yet recruiting NCT05723757 - Autophagy Dysfunction in Hidradenitis Suppurativa N/A
Completed NCT02808975 - Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically Phase 4
Completed NCT04430855 - A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms Phase 2
Recruiting NCT06212999 - A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Active, not recruiting NCT04354012 - Hidradenitis Suppurativa Wound Care Phase 2
Completed NCT03487276 - Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Recruiting NCT05620836 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 3
Not yet recruiting NCT05735925 - The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis N/A
Recruiting NCT05620823 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Recruiting NCT06241573 - A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab Phase 2/Phase 3
Available NCT05583604 - Secukinumab Global MAP Cohort for Adult Patients With Hidradenitis Suppurativa (HS)

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