Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects

NCT03001115 | Completed

• 1 other identifier: P16-052
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Adalimumab; Safety; Hidradenitis Suppurativa; Korean participants

Outcome Measures

Primary Outcomes (1)

• Assessing adverse events

  Adverse event information is collected to assess prevalence of safety.

  Up to 70 days following the last administration of Humira®

Secondary Outcomes (2)

• Change from baseline in Dermatology Life Quality Index (DLQI)

  Week 0 (baseline), Week 12, and Week 24

• Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)

  Week 0 (baseline), Week 12, and Week 24

Study Arms (1)

Participants with Hidradenitis suppurativa (HS)

Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participant who are contraindications to adalimumab as listed on the approved Korean label.
• Participant who is participating on other clinical trials.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (19)

Kyungpook National Univ Hosp /ID# 162930

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Seoul National Univ Bundang ho /ID# 202254

Seongnam, Gyeonggido, 13620, South Korea

Location

CHA Bundang Medical center, CHA University /ID# 203364

Seongnam-si, Gyeonggido, 13496, South Korea

Location

Ajou University Hospital /ID# 163243

Suwon, Gyeonggido, 16499, South Korea

Location

Chonnam National University Hospital /ID# 162932

Gwangju, Jeonranamdo, 61469, South Korea

Location

Yonsei University Health System, Severance Hospital /ID# 162933

Seodaemun-gu, Seoul Teugbyeolsi, 03722, South Korea

Location

Seoul SongDo Hospital /ID# 202597

Seoul, Seoul Teugbyeolsi, 04597, South Korea

Location

Gangnam Severance Hospital /ID# 162924

Seoul, Seoul Teugbyeolsi, 06273, South Korea

Location

Samsung Medical Center /ID# 162934

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

St. Mary's Hospital of the Cat /ID# 162923

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Dong-A University Hospital /ID# 162931

Busan, 49201, South Korea

Location

Korea University Anam Hospital /ID# 162922

Seoul, 02841, South Korea

Location

Seoul National University Hospital /ID# 162935

Seoul, 03080, South Korea

Location

Hangyang University Medical Ce /ID# 162929

Seoul, 04763, South Korea

Location

Konkuk University Medical Cent /ID# 162927

Seoul, 05030, South Korea

Location

Asan Medical Center /ID# 162925

Seoul, 05505, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital /ID# 162926

Seoul, 07441, South Korea

Location

Ewha Womans University Mokdong /ID# 162928

Seoul, 07985, South Korea

Location

National Medical Center /ID# 162936

Seoul, 100-799, South Korea

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: March 10, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

KR (19)