Hidradenitis SuppurativaVESPANCT03668925
Association Between Hidradenitis Suppurativa and Spondyloarthritis
A study testing magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement in people with Hidradenitis Suppurativa, run by CHU de Reims at 1 site in France.
Trial summary
Hidradenitis suppurativa is a chronic dermatosis, characterized by an inflammation of the follicular epithelium in the apocrine glands. The hypothesis of a link between hidradenitis suppurativa and inflammatory rheumatism has been widely considered, with evidence in support of this theory accumulating from several… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2013to 1 Sep 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- for case: patients with diagnosis of hidrosadenitis suppurativa in the Department of Dermatology of the University Hospital of Reims, regardless of the stage of severity and duration of their disease
- for control: patients without diagnosis of hidrosadenitis suppurativa matched to cases for age (±5 years) and sex
- for case and control: have accepted to take part in the research
Who cannot join
- for case and control: age <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Hidradenitis suppurativa is a chronic dermatosis, characterized by an inflammation of the follicular epithelium in the apocrine glands.
The hypothesis of a link between hidradenitis suppurativa and inflammatory rheumatism has been widely considered, with evidence in support of this theory accumulating from several case reports and small series. The most frequently cited rheumatismal disease thought to be associated with Hidradenitis suppurativa is spondyloarthritis.
Taken together, these data suggest that there may a link between hidradenitis suppurativa and spondyloarthritis, but literature data are sparse, and to date, no study has investigated or demonstrated such a relation. Indeed, existing studies to date were observational, descriptive, and retrospective, and did not use modern diagnostic approaches for documenting spondyloarthritis, such as magnetic resonance imaging (MRI) or the recent classification of spondyloarthritis.
Read the detailed description
The aim of the study was to test the hypothesis that the risk of spondyloarthritis is increased in patients with hidradenitis suppurativa.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
- Keywords
- spondyloarthritis, hidrosadenitis suppurativa, inflammation, magnetic resonance imaging
- Medical subject headings
- Hidradenitis Suppurativa, Spondylarthritis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurementRadiation
magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
| Study group | Role | What they receive |
|---|---|---|
| Group "Case" | Experimental | patient diagnosed with hidrosadenitis suppurativa Receives: Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement |
| Group "control" | Active comparator | patient without hidrosadenitis suppurativa Receives: Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
spondyloarthritis
spondyloarthritis was diagnosed by a rheumatologist using the Assessment of SpondyloArthritis international Society (ASAS) criteria
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 May 2013
- Primary completion1 Apr 2014
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668925
- Sponsor's protocol ID
- PJ12076
- Acronym
- VESPA
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fauconier M, Reguiai Z, Barbe C, Colosio A, Eschard JP, Salmon JH, Direz G. Association between hidradenitis suppurativa and spondyloarthritis. Joint Bone Spine. 2018 Oct;85(5):593-597. doi: 10.1016/j.jbspin.2017.09.005. Epub 2017 Sep 28.
PubMed 28965938
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Hidradenitis Suppurativa and Spondyloarthritis
- ClinicalTrials.gov ID
- NCT03668925
- Acronym / sponsor ID
- VESPA / PJ12076
- Conditions
- Hidradenitis Suppurativa
- Keywords
- spondyloarthritis, hidrosadenitis suppurativa, inflammation, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 13 Sep 2018 (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.
Hidradenitis suppurativa is a chronic dermatosis, characterized by an inflammation of the follicular epithelium in the apocrine glands.
The hypothesis of a link between hidradenitis suppurativa and inflammatory rheumatism has been widely considered, with evidence in support of this theory accumulating from several case reports and small series. The most frequently cited rheumatismal disease thought to be associated with Hidradenitis suppurativa is spondyloarthritis.
Taken together, these data suggest that there may a link between hidradenitis suppurativa and spondyloarthritis, but literature data are sparse, and to date, no study has investigated or demonstrated such a relation. Indeed, existing studies to date were observational, descriptive, and retrospective, and did not use modern diagnostic approaches for documenting spondyloarthritis, such as magnetic resonance imaging (MRI) or the recent classification of spondyloarthritis.
Detailed description
The aim of the study was to test the hypothesis that the risk of spondyloarthritis is increased in patients with hidradenitis suppurativa.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "Case" | Experimental | Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurementpatient diagnosed with hidrosadenitis suppurativa |
| Group "control" | Active comparator | Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurementpatient without hidrosadenitis suppurativa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- for case: patients with diagnosis of hidrosadenitis suppurativa in the Department of Dermatology of the University Hospital of Reims, regardless of the stage of severity and duration of their disease
- for control: patients without diagnosis of hidrosadenitis suppurativa matched to cases for age (±5 years) and sex
- for case and control: have accepted to take part in the research
Key exclusion criteria (1 listed)
- for case and control: age <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurementmagnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement | Radiation | Group "Case", Group "control" |
Primary outcome
spondyloarthritis
Time frame: Day 0
spondyloarthritis was diagnosed by a rheumatologist using the Assessment of SpondyloArthritis international Society (ASAS) criteria
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 13 Sep 2018.
- Background: PubMed 28965938Fauconier M, Reguiai Z, Barbe C, Colosio A, Eschard JP, Salmon JH, Direz G. Association between hidradenitis suppurativa and spondyloarthritis. Joint Bone Spine. 2018 Oct;85(5):593-597. doi: 10.1016/j.jbspin.2017.09.005. Epub 2017 Sep 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement in people with Hidradenitis Suppurativa, run by CHU de Reims at 1 site in France.
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 3 inclusion and 1 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
spondyloarthritis (time frame: Day 0). 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 NCT03668925, which also lists 1 linked publication.
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 13 Sep 2018.