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Trial record 8 of 91 for:    hidradenitis suppurativa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03001115
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : October 16, 2019
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)

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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 : March 10, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 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


Locations
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Korea, Republic of
Kyungpook National Univ Hosp /ID# 162930
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
CHA Bundang Medical center, CHA University /ID# 203364
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Seoul National Univ Bundang ho /ID# 202254
Seongnam, Gyeonggido, Korea, Republic of, 13620
Ajou University Hospital /ID# 163243
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Chonnam National University Hospital /ID# 162932
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Yonsei University Health System, Severance Hospital /ID# 162933
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Seoul SongDo Hospital /ID# 202597
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04597
Gangnam Severance Hospital /ID# 162924
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
Samsung Medical Center /ID# 162934
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
St. Mary's Hospital of the Cat /ID# 162923
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Dong-A University Hospital /ID# 162931
Busan, Korea, Republic of, 49201
Korea University Anam Hospital /ID# 162922
Seoul, Korea, Republic of, 02841
Seoul National University Hospital /ID# 162935
Seoul, Korea, Republic of, 03080
Hangyang University Medical Ce /ID# 162929
Seoul, Korea, Republic of, 04763
Konkuk University Medical Cent /ID# 162927
Seoul, Korea, Republic of, 05030
Asan Medical Center /ID# 162925
Seoul, Korea, Republic of, 05505
Hallym University Kangnam Sacred Heart Hospital /ID# 162926
Seoul, Korea, Republic of, 07441
Ewha Womans University Mokdong /ID# 162928
Seoul, Korea, Republic of, 07985
National Medical Center /ID# 162936
Seoul, Korea, Republic of, 100-799
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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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: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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