Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects

Hidradenitis Suppurativa (HS) Clinical Trial

— HS rPMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001115
• Other study ID #: P16-052
• Status: Completed
• Start date: March 10, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: June 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital /ID# 162931	Busan
Korea, Republic of	Kyungpook National Univ Hosp /ID# 162930	Daegu	Daegu Gwang Yeogsi
Korea, Republic of	Chonnam National University Hospital /ID# 162932	Gwangju	Jeonranamdo
Korea, Republic of	Yonsei University Health System, Severance Hospital /ID# 162933	Seodaemun-gu	Seoul Teugbyeolsi
Korea, Republic of	Seoul National Univ Bundang ho /ID# 202254	Seongnam	Gyeonggido
Korea, Republic of	CHA Bundang Medical center, CHA University /ID# 203364	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 162925	Seoul
Korea, Republic of	Ewha Womans University Mokdong /ID# 162928	Seoul
Korea, Republic of	Gangnam Severance Hospital /ID# 162924	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital /ID# 162926	Seoul
Korea, Republic of	Hangyang University Medical Ce /ID# 162929	Seoul
Korea, Republic of	Konkuk University Medical Cent /ID# 162927	Seoul
Korea, Republic of	Korea University Anam Hospital /ID# 162922	Seoul
Korea, Republic of	National Medical Center /ID# 162936	Seoul
Korea, Republic of	Samsung Medical Center /ID# 162934	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 162935	Seoul
Korea, Republic of	Seoul SongDo Hospital /ID# 202597	Seoul	Seoul Teugbyeolsi
Korea, Republic of	St. Mary's Hospital of the Cat /ID# 162923	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Ajou University Hospital /ID# 163243	Suwon-si	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing adverse events	Adverse event information is collected to assess prevalence of safety.	Up to 70 days following the last administration of Humira®
Secondary	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).	Week 0 (baseline), Week 12, and Week 24
Secondary	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.	Week 0 (baseline), Week 12, and Week 24

External Links

•   clinical study report synopsis