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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT03001115

Collaborator

(none)

Enrollment

Locations

28.7

Actual Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa (HS)

Study Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 10, 2017

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Participants with Hidradenitis suppurativa (HS) Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice.

Outcome Measures

Primary Outcome Measures

Assessing adverse events [Up to 70 days following the last administration of Humira®]
Adverse event information is collected to assess prevalence of safety.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

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