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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Participants with Hidradenitis suppurativa (HS)
Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Hidradenitis Suppurativa (HS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings