Back to resultsAssociation Between Hidradenitis Suppurativa and Spondyloarthritis (VESPA)
Primary Purpose
Hidradenitis Suppurativa
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
Sponsored by
About this trial
This is an interventional other trial for Hidradenitis Suppurativa focused on measuring spondyloarthritis, hidrosadenitis suppurativa, inflammation, magnetic resonance imaging
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- for case and control: age <18 years old
Sites / Locations
- Damien JOLLY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group "Case"
Group "control"
Arm Description
patient diagnosed with hidrosadenitis suppurativa
patient without hidrosadenitis suppurativa
Outcomes
Primary Outcome Measures
spondyloarthritis
spondyloarthritis was diagnosed by a rheumatologist using the Assessment of SpondyloArthritis international Society (ASAS) criteria
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03668925
Brief Title
Association Between Hidradenitis Suppurativa and Spondyloarthritis
Acronym
VESPA
Official Title
Association Between Hidradenitis Suppurativa and Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
April 1, 2014 (Actual)
Study Completion Date
September 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
spondyloarthritis, hidrosadenitis suppurativa, inflammation, magnetic resonance imaging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group "Case"
Arm Type
Experimental
Arm Description
patient diagnosed with hidrosadenitis suppurativa
Arm Title
Group "control"
Arm Type
Active Comparator
Arm Description
patient without hidrosadenitis suppurativa
Intervention Type
Radiation
Intervention Name(s)
magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
Intervention Description
magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
Primary Outcome Measure Information:
Title
spondyloarthritis
Description
spondyloarthritis was diagnosed by a rheumatologist using the Assessment of SpondyloArthritis international Society (ASAS) criteria
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
for case and control: age <18 years old
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28965938
Citation
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.
Results Reference
background
Learn more about this trial
Association Between Hidradenitis Suppurativa and Spondyloarthritis
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