Hidradenitis Suppurativa (HS)NCT03894956
Observational Study Evaluating Long-Term Safety and Effectiveness of Humira in Patients With Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa (HS), run by AbbVie at 37 sites in Japan.
Trial summary
The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- How many people
- 46 participants
- Where
- 37 sitesJapan
- Study dates
- 2 May 2019to 10 Nov 2021
- 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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hidradenitis Suppurativa (HS)
Who may be able to join
- Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS.
Who cannot join
- Participants previously treated with Humira.
- Participants who do not provide consent.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Japan37 sites
Anjou Kousei Hospital /ID# 216741
Anjo-shi, Aichi-ken, 446-8602
Kyushu University Hospital /ID# 214092
Fukuoka, Fukuoka, 812-8582
JA Shizuoka Kohseiren Ensh Hospital /ID# 218160
Hamamatsu, Shizuoka, 430-0929
JA Hiroshima General Hospital /ID# 213472
Hatsukaichi-shi, Hiroshima, 738-8503
Japanese Red Cross Kitami Hospital /ID# 214085
Hokkaido, 078-8510
Ichinomiya Municipal Hospital /ID# 214086
Ichinomiya-shi, Aichi-ken, 491-8558
Nara Hospital Kinki University Faculty of Medicine, /ID# 218640
Ikoma-shi, Nara, 630-0227
Saitama Medical University Hospital /ID# 215599
Iruma-gun, Saitama, 350-0495
Saitama Medical Center /ID# 218639
Kawagoe-shi, Saitama, 350-8550
Kimitsu Chuo Hospital /ID# 214733
Kisarazu-shi, Chiba, 292-8535
Kishiwada City Hospital /ID# 213471
Kishiwada-shi, Osaka, 596-8501
Hospital of the University of Occupational and Environmental Health, Japan /ID# 214137
Kitakyushu-shi, Fukuoka, 807-8556
Kobe University Hospital /ID# 215642
Kobe, Hyōgo, 650-0017
Bito Dermatology Clinic /ID# 215316
Kobe, Hyōgo, 651-0095
Kyoto University Hospital /ID# 215315
Kyoto, Kyoto, 606-8507
Toranomon Hospital /ID# 213470
Minato-ku, Tokyo, 105-8470
Mito Kyodo General Hospital /ID# 214089
Mito, Ibaraki, 310-0015
Aichi Medical University Hospital /ID# 215312
Nagakute-shi, Aichi-ken, 480-1195
NHO Nagoya Medical Center /ID# 214406
Nagoya, Aichi-ken, 460-0001
Nagoya University Hospital /ID# 214135
Nagoya, Aichi-ken, 4668560
University of the Ryukyus Hospital /ID# 214136
Nakagami-gun, Okinawa, 903-0215
Kochi Medical School Hospital /ID# 214091
Nankoku-shi, Kochi, 783-8505
Okayama University Hospital /ID# 215317
Okayama, Okayama-ken, 700-8558
Kindai University Hospital /ID# 217831
Osakasayama-shi, Osaka, 589-8511
Sapporo Higashi Tokushukai Hospital /ID# 213865
Sapporo, Hokkaido, 065-0033
Tohoku University Hospital /ID# 217830
Sendai, Miyagi, 9808574
Tohoku Rosai Hospital /ID# 214084
Sendai, Miyagi, 981-8563
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 214134
Shinjuku-ku, Tokyo, 169-0073
Shizuoka City Shizuoka Hospital /ID# 217292
Shizuoka, Shizuoka, 420-0853
Osaka University Hospital /ID# 215314
Suita-shi, Osaka, 565-0871
Takarazuka City Hospital /ID# 214088
Takarazuka-shi, Hyōgo, 665-0827
Osaka Medical and Pharmaceutical University Hospital /ID# 214087
Takatsuki-shi, Osaka, 569-8686
Ehime University Hospital /ID# 214090
Toon-shi, Ehime, 791-0295
Toyama University Hospital /ID# 214407
Toyama, Toyama, 930-0194
Yokkaichi Municipal Hospital /ID# 215641
Yokkaichi-shi, Mie-ken, 510-0822
Yokohama City University Medical Center /ID# 216740
Yokohama, Kanagawa, 232-0024
Yokosuka Kyosai Hospital /ID# 215310
Yokosuka-shi, Kanagawa, 238-8558
About this study
Official title: Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa
The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Hidradenitis Suppurativa (HS), Humira, Adalimumab
- 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 who along with their treating physician have elected for treatment with Humira as per routine clinical practice for the treatment of HS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who reported any serious infections during the study
Percentage of participants with incidence of serious infections are reported.
Measured: Up to Week 52
Percentage of participants who reported any adverse drug reactions (ADRs) during the study
ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Measured: Up to Week 52
Percentage of participants who reported any infections during the study
Percentage of participants with incidence of infections are reported.
Measured: Up to Week 52
Secondary outcomes (5)
Percentage of participants achieving "Improved" of overall improvement by physician
Percentage of participants achieving overall improvement (improved, unchanged, impossible to evaluate) is assessed by physician.
Measured: Up to Week 52
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
HiSCR is defined as at least 50% reduction in the number of abscesses and inflammatory nodules and no increase in abscess count and no increase in draining fistula count relative to baseline.
Measured: Up to week 52
Change in C-Reactive Protein (CRP)
CRP values are measured as an inflammatory parameter. Low CRP values mean less inflammation.
Measured: From Baseline to Week 52
Change in Patient's global assessment of skin pain
Patient's global assessment of skin pain is evaluated on a 11-point scale with 0 for "no pain" and 10 for "worst skin pain imaginable."
Measured: From Baseline to Week 52
Change in Dermatology Life Quality Index (DLQI)
DLQI is a 10-question validated dermatologic disease questionnaire to measure quality of life.
Measured: From Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start2 May 2019
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 46 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
- NCT03894956
- Sponsor's protocol ID
- P18-835
- Status last verified
- Nov 2022
- First submitted
- 27 Mar 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. J Dermatol. 2023 Aug;50(8):1034-1044. doi: 10.1111/1346-8138.16835. Epub 2023 Jun 2.
PubMed 37264993Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan. J Dermatol. 2022 Apr;49(4):411-421. doi: 10.1111/1346-8138.16297. Epub 2022 Jan 17.
PubMed 35040156
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03894956
- Acronym / sponsor ID
- P18-835
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Hidradenitis Suppurativa (HS), Humira, Adalimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 29 Mar 2019 (actual)
- 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 long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Hidradenitis Suppurativa (HS) | – | –Participants who along with their treating physician have elected for treatment with Humira as per routine clinical practice for the treatment of HS |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hidradenitis Suppurativa (HS)
Key inclusion criteria (1 listed)
- Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS.
Key exclusion criteria (2 listed)
- Participants previously treated with Humira.
- Participants who do not provide consent.
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
Percentage of participants who reported any serious infections during the study
Time frame: Up to Week 52
Percentage of participants with incidence of serious infections are reported.
Percentage of participants who reported any adverse drug reactions (ADRs) during the study
Time frame: Up to Week 52
ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Percentage of participants who reported any infections during the study
Time frame: Up to Week 52
Percentage of participants with incidence of infections are reported.
5 secondary outcomes
Percentage of participants achieving "Improved" of overall improvement by physician
Time frame: Up to Week 52
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: Up to week 52
Change in C-Reactive Protein (CRP)
Time frame: From Baseline to Week 52
Change in Patient's global assessment of skin pain
Time frame: From Baseline to Week 52
Change in Dermatology Life Quality Index (DLQI)
Time frame: From Baseline to Week 52
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 3 Nov 2022.
- Derived from this study: PubMed 37264993Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: A 52-week analysis of a postmarketing surveillance study in Japan. J Dermatol. 2023 Aug;50(8):1034-1044. doi: 10.1111/1346-8138.16835. Epub 2023 Jun 2.
- Derived from this study: PubMed 35040156Hayashi N, Hayama K, Takahashi K, Kurokawa I, Okazaki M, Kashiwagi T, Iwashita E, Terui T. Real-world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12-week interim analysis of post-marketing surveillance in Japan. J Dermatol. 2022 Apr;49(4):411-421. doi: 10.1111/1346-8138.16297. Epub 2022 Jan 17.
- Individual participant dataSharing planned: Undecided
Related trials for Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.
Hidradenitis Suppurativa
Not yet recruitingObservational study
A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients
Hidradenitis Suppurativa
Active, not recruitingPhase 2
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study With CIT-013 in HS Patients
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
A Study of SPY072 in Adults With Moderate to Severe Hidradenitis Suppurativa (The SKYLIGHT Trial)
Hidradenitis Suppurativa (HS)
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
37 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 37 sites in Japan.
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 1 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Japan. 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?
Percentage of participants who reported any serious infections during the study (time frame: Up to Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894956, which also lists 2 linked publications.
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 3 Nov 2022.