Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects

AbbVie17 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hidradenitis Suppurativa (HS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (19)

Kyungpook National Univ Hosp /ID# 162930

Daegu, Daegu Gwang Yeogsi, South Korea

Outcomes

Primary Outcomes

Assessing adverse events

Adverse event information is collected to assess prevalence of safety.

Time frame: Up to 70 days following the last administration of Humira®

Secondary Outcomes

Change from baseline in Dermatology Life Quality Index (DLQI)

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).

Time frame: Week 0 (baseline), Week 12, and Week 24

Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)

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.

Time frame: Week 0 (baseline), Week 12, and Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.