Hidradenitis Suppurativa (HS)HS rPMSNCT03001115
Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
An observational study of Hidradenitis Suppurativa (HS), run by AbbVie at 19 sites in South Korea.
Trial summary
The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- How many people
- 17 participants
- Where
- 19 sitesSouth Korea
- Study dates
- 10 Mar 2017to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hidradenitis suppurativa (HS) participants who have been prescribed Adalimumab by the treating investigator as per approved label in Korea will be enrolled.
Who may be able to join
- 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.
Who cannot join
- Participant who are contraindications to adalimumab as listed on the approved Korean label.
- Participant who is participating on other clinical trials.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
South Korea19 sites
Dong-A University Hospital /ID# 162931
Busan, 49201
Kyungpook National Univ Hosp /ID# 162930
Daegu, Daegu Gwang Yeogsi, 41944
Chonnam National University Hospital /ID# 162932
Gwangju, Jeonranamdo, 61469
Yonsei University Health System, Severance Hospital /ID# 162933
Seodaemun-gu, Seoul Teugbyeolsi, 03722
Seoul National Univ Bundang ho /ID# 202254
Seongnam, Gyeonggido, 13620
CHA Bundang Medical center, CHA University /ID# 203364
Seongnam-si, Gyeonggido, 13496
Seoul SongDo Hospital /ID# 202597
Seoul, Seoul Teugbyeolsi, 04597
Gangnam Severance Hospital /ID# 162924
Seoul, Seoul Teugbyeolsi, 06273
Samsung Medical Center /ID# 162934
Seoul, Seoul Teugbyeolsi, 06351
St. Mary's Hospital of the Cat /ID# 162923
Seoul, Seoul Teugbyeolsi, 06591
Korea University Anam Hospital /ID# 162922
Seoul, 02841
Seoul National University Hospital /ID# 162935
Seoul, 03080
Hangyang University Medical Ce /ID# 162929
Seoul, 04763
Konkuk University Medical Cent /ID# 162927
Seoul, 05030
Asan Medical Center /ID# 162925
Seoul, 05505
Hallym University Kangnam Sacred Heart Hospital /ID# 162926
Seoul, 07441
Ewha Womans University Mokdong /ID# 162928
Seoul, 07985
National Medical Center /ID# 162936
Seoul, 100-799
Ajou University Hospital /ID# 163243
Suwon, Gyeonggido, 16499
About this study
Official title: Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the "New-Drug Re-examination
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
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Hidradenitis suppurativa (HS) | Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing adverse events
Adverse event information is collected to assess prevalence of safety.
Measured: Up to 70 days following the last administration of Humira®
Secondary outcomes (2)
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).
Measured: Week 0 (baseline), Week 12, and Week 24
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.
Measured: Week 0 (baseline), Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start10 Mar 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001115
- Sponsor's protocol ID
- P16-052
- Acronym
- HS rPMS
- Status last verified
- Jun 2020
- First submitted
- 20 Dec 2016
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the "New-Drug Re-examination
- ClinicalTrials.gov ID
- NCT03001115
- Acronym / sponsor ID
- HS rPMS / P16-052
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Adalimumab, Safety, Hidradenitis Suppurativa, Korean participants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Hidradenitis suppurativa (HS) | – | –Participants with HS treated with adalimumab (HUMIRA®) in routine clinical practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hidradenitis suppurativa (HS) participants who have been prescribed Adalimumab by the treating investigator as per approved label in Korea will be enrolled.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Participant who are contraindications to adalimumab as listed on the approved Korean label.
- Participant who is participating on other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Change from baseline in Dermatology Life Quality Index (DLQI)
Time frame: Week 0 (baseline), Week 12, and Week 24
Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: Week 0 (baseline), Week 12, and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Hidradenitis Suppurativa (HS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa (HS), run by AbbVie at 19 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing adverse events (time frame: Up to 70 days following the last administration of Humira®). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.