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

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ClinicalTrials.gov Identifier: NCT03001115
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
Hidradenitis Suppurativa (HS)

Study Type : Observational
Estimated Enrollment : 600 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 : March 10, 2017
Estimated Primary Completion Date : July 26, 2019
Estimated Study Completion Date : July 26, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Participants with Hidradenitis suppurativa (HS)
Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice.



Primary Outcome Measures :
  1. Assessing adverse events [ Time Frame: Up to 70 days following the last administration of Humira® ]
    Adverse event information is collected to assess prevalence of safety.


Secondary Outcome Measures :
  1. Change from baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: 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).

  2. Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001115


Contacts
Contact: Haney Choi +82-3429-9235 haney.choi@abbvie.com
Contact: Eunjung Gu +82-2-3429-9399 eunjung.gu@abbvie.com

Locations
Korea, Republic of
Kyungpook National Univ Hosp Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
Seoul National Univ Bundang ho Not yet recruiting
Seongnam, Gyeonggido, Korea, Republic of, 13620
Ajou University Hospital Recruiting
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Chonnam National University Hospital Not yet recruiting
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Severance Hospital, Yonsei University Health System Not yet recruiting
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Seoul National University Hospital Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
Samsung Medical Center Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
St. Mary's Hospital of the Cat Not yet recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Dong-A University Hospital Not yet recruiting
Busan, Korea, Republic of, 49201
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of, 02841
National Medical Center Recruiting
Seoul, Korea, Republic of, 100-799
Abbott South Korea Not yet recruiting
Seoul, Korea, Republic of, 135-846
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03001115     History of Changes
Other Study ID Numbers: P16-052
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Adalimumab
Safety
Hidradenitis Suppurativa
Korean participants

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents