Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects (HS rPMS)

June 11, 2020 updated by: AbbVie

Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the "New-Drug Re-examination

The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

17

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital /ID# 162931
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital /ID# 162922
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 162935
      • Seoul, Korea, Republic of, 04763
        • Hangyang University Medical Ce /ID# 162929
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Cent /ID# 162927
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center /ID# 162925
      • Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Heart Hospital /ID# 162926
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong /ID# 162928
      • Seoul, Korea, Republic of, 100-799
        • National Medical Center /ID# 162936
    • Daegu Gwang Yeogsi
      • Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
        • Kyungpook National Univ Hosp /ID# 162930
    • Gyeonggido
      • Seongnam, Gyeonggido, Korea, Republic of, 13620
        • Seoul National Univ Bundang ho /ID# 202254
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13496
        • CHA Bundang Medical center, CHA University /ID# 203364
      • Suwon-si, Gyeonggido, Korea, Republic of, 16499
        • Ajou University Hospital /ID# 163243
    • Jeonranamdo
      • Gwangju, Jeonranamdo, Korea, Republic of, 61469
        • Chonnam National University Hospital /ID# 162932
    • Seoul Teugbyeolsi
      • Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Yonsei University Health System, Severance Hospital /ID# 162933
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04597
        • Seoul SongDo Hospital /ID# 202597
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
        • Gangnam Severance Hospital /ID# 162924
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 162934
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
        • St. Mary's Hospital of the Cat /ID# 162923

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hidradenitis suppurativa (HS) participants who have been prescribed Adalimumab by the treating investigator as per approved label in Korea will be enrolled.

Description

Inclusion Criteria:

  • Participant who are eligible to be treated with adalimumab for HS in accordance with the approved Korean label
  • Participant must provide written authorization form to use their personal health data prior to the participating in the study.

Exclusion Criteria:

  • Participant who are contraindications to adalimumab as listed on the approved Korean label.
  • Participant who is participating on other clinical trials.

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 with HS treated with adalimumab (HUMIRA®) in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing adverse events
Time Frame: Up to 70 days following the last administration of Humira®
Adverse event information is collected to assess prevalence of safety.
Up to 70 days following the last administration of Humira®

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Dermatology Life Quality Index (DLQI)
Time Frame: Week 0 (baseline), Week 12, and Week 24
DLQI will be collected to evaluate effectiveness of adalimumab. DLQI has 10 quality of life domains scored from 0 (no effect) to thirty (very large effect).
Week 0 (baseline), Week 12, and Week 24
Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)
Time Frame: Week 0 (baseline), Week 12, and Week 24
The HiSCR measure is designed to assess treatment response in a binary manner, rather than being a continuous or ordinal scale. It includes a count of the total number of abscesses and inflammatory nodules (ANs), as well as recording the number of sinuses draining purulent fluid present in an individual. Treatment responders are defined as those who achieve at least a 50% reduction in ANs, with no increase in the number of abscesses or draining sinuses, relative to baseline.
Week 0 (baseline), Week 12, and Week 24

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.

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)

March 10, 2017

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

July 31, 2019

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (ESTIMATE)

December 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16-052

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.

No

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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