Clinical trial NCT03001115: Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
Official title: Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the "New-Drug Re-examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Adalimumab
Safety
Hidradenitis Suppurativa
Korean participants
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hidradenitis suppurativa (HS) participants who have been prescribed Adalimumab by the treating investigator as per approved label in Korea will be enrolled.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Assessing adverse events
timeFrame: Up to 70 days following the last administration of Humira®
Secondary outcomes:
measure: Change from baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Week 0 (baseline), Week 12, and Week 24
measure: Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)
timeFrame: Week 0 (baseline), Week 12, and Week 24
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ Hosp /ID# 162930
state: Daegu Gwang Yeogsi
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical center, CHA University /ID# 203364
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ Bundang ho /ID# 202254
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 163243
state: Gyeonggido
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 162932
state: Jeonranamdo
city: Seodaemun-gu
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital /ID# 162933
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul SongDo Hospital /ID# 202597
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 162924
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 162934
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital of the Cat /ID# 162923
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital /ID# 162931
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 162922
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 162935
city: Seoul
country: Korea, Republic of
facility: Hangyang University Medical Ce /ID# 162929
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Cent /ID# 162927
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 162925
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital /ID# 162926
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong /ID# 162928
city: Seoul
country: Korea, Republic of
facility: National Medical Center /ID# 162936
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: