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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001115
Other study ID # P16-052
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
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Completed NCT02896920 - Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
Completed NCT01468233 - Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa Phase 3
Completed NCT01468207 - Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa Phase 3
Completed NCT03894956 - Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
Not yet recruiting NCT05723757 - Autophagy Dysfunction in Hidradenitis Suppurativa N/A
Completed NCT02808975 - Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically Phase 4
Completed NCT04430855 - A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms Phase 2
Recruiting NCT06212999 - A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Active, not recruiting NCT04354012 - Hidradenitis Suppurativa Wound Care Phase 2
Completed NCT03487276 - Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Recruiting NCT05620836 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 3
Not yet recruiting NCT05735925 - The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis N/A
Recruiting NCT05620823 - A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa Phase 3
Recruiting NCT06241573 - A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab Phase 2/Phase 3
Available NCT05583604 - Secukinumab Global MAP Cohort for Adult Patients With Hidradenitis Suppurativa (HS)

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