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

November 1, 2022 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan, 078-8510
        • Japanese Red Cross Kitami Hospital /ID# 214085
    • Aichi
      • Anjo-shi, Aichi, Japan, 446-8602
        • Anjou Kousei Hospital /ID# 216741
      • Ichinomiya-shi, Aichi, Japan, 491-8558
        • Ichinomiya Municipal Hospital /ID# 214086
      • Nagakute-shi, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital /ID# 215312
      • Nagoya-shi, Aichi, Japan, 460-0001
        • NHO Nagoya Medical Center /ID# 214406
      • Nagoyashi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 214135
    • Chiba
      • Kisarazu-shi, Chiba, Japan, 292-8535
        • Kimitsu Chuo Hospital /ID# 214733
    • Ehime
      • Toon-shi, Ehime, Japan, 791-0295
        • Ehime University Hospital /ID# 214090
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 214092
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137
    • Hiroshima
      • Hatsukaichi-shi, Hiroshima, Japan, 738-8503
        • JA Hiroshima General Hospital /ID# 213472
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital /ID# 213865
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital /ID# 215642
      • Kobe-shi, Hyogo, Japan, 651-0095
        • Bito Dermatology Clinic /ID# 215316
      • Takarazuka-shi, Hyogo, Japan, 665-0827
        • Takarazuka City Hospital /ID# 214088
    • Ibaraki
      • Mito-shi, Ibaraki, Japan, 310-0015
        • Mito Kyodo General Hospital /ID# 214089
    • Kanagawa
      • Yokohama shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center /ID# 216740
      • Yokosuka-shi, Kanagawa, Japan, 238-8558
        • Yokosuka Kyosai Hospital /ID# 215310
    • Kochi
      • Nankoku-shi, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital /ID# 214091
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 215315
    • Mie
      • Yokkaichi-shi, Mie, Japan, 510-0822
        • Yokkaichi Municipal Hospital /ID# 215641
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 217830
      • Sendai-shi, Miyagi, Japan, 981-8563
        • Tohoku Rosai Hospital /ID# 214084
    • Nara
      • Ikoma-shi, Nara, Japan, 630-0227
        • Nara Hospital Kinki University Faculty of Medicine, /ID# 218640
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital /ID# 215317
    • Okinawa
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • University of the Ryukyus Hospital /ID# 214136
    • Osaka
      • Kishiwada-shi, Osaka, Japan, 596-8501
        • Kishiwada City Hospital /ID# 213471
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital /ID# 217831
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital /ID# 215314
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical and Pharmaceutical University Hospital /ID# 214087
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Saitama Medical University Hospital /ID# 215599
      • Kawagoe-shi, Saitama, Japan, 350-8550
        • Saitama Medical Center /ID# 218639
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 430-0929
        • JA Shizuoka Kohseiren Ensh Hospital /ID# 218160
      • Shizuoka-shi, Shizuoka, Japan, 420-0853
        • Shizuoka City Shizuoka Hospital /ID# 217292
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital /ID# 213470
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-0194
        • Toyama University Hospital /ID# 214407

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hidradenitis Suppurativa (HS)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants with Hidradenitis Suppurativa (HS)
Participants who along with their treating physician have elected for treatment with Humira as per routine clinical practice for the treatment of HS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who reported any serious infections during the study
Time Frame: Up to Week 52
Percentage of participants with incidence of serious infections are reported.
Up to Week 52
Percentage of participants who reported any adverse drug reactions (ADRs) during the study
Time Frame: Up to Week 52
ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Up to Week 52
Percentage of participants who reported any infections during the study
Time Frame: Up to Week 52
Percentage of participants with incidence of infections are reported.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving "Improved" of overall improvement by physician
Time Frame: Up to Week 52
Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician.
Up to Week 52
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
Time Frame: 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.
Up to week 52
Change in C-Reactive Protein (CRP)
Time Frame: From Baseline to Week 52
CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation.
From Baseline to Week 52
Change in Patient's global assessment of skin pain
Time Frame: 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."
From Baseline to Week 52
Change in Dermatology Life Quality Index (DLQI)
Time Frame: From Baseline to Week 52
DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life.
From Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2019

Primary Completion (ACTUAL)

November 10, 2021

Study Completion (ACTUAL)

November 10, 2021

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (ACTUAL)

March 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P18-835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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