Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03001115

Acronym

HS rPMS

Enrollment

Registered

2016-12-22

Start date

2017-03-10

Completion date

2019-07-31

Last updated

2020-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Adalimumab, Safety, Hidradenitis Suppurativa, Korean participants

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change from baseline in Dermatology Life Quality Index (DLQI)	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)	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.

Countries

South Korea

Outcome results