Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects

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

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Key information

Conditions

Hidradenitis Suppurativa (HS) Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hidradenitis Suppurativa Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National Univ Hosp /ID# 162930, Daegu, Daegu Gwang Yeogsi, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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).
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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: HS rPMS

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Dec 22, 2016
Registry last updated: Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed