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Association Between Hidradenitis Suppurativa and Spondyloarthritis (VESPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668925
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement Not Applicable

Detailed Description:
The aim of the study was to test the hypothesis that the risk of spondyloarthritis is increased in patients with hidradenitis suppurativa.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Association Between Hidradenitis Suppurativa and Spondyloarthritis
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : April 1, 2014
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group "Case"
patient diagnosed with hidrosadenitis suppurativa
Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement

Active Comparator: Group "control"
patient without hidrosadenitis suppurativa
Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement




Primary Outcome Measures :
  1. spondyloarthritis [ Time Frame: Day 0 ]
    spondyloarthritis was diagnosed by a rheumatologist using the Assessment of SpondyloArthritis international Society (ASAS) criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668925


Locations
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France
Damien JOLLY
Reims, France
Sponsors and Collaborators
CHU de Reims

Publications:
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03668925    
Other Study ID Numbers: PJ12076
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
spondyloarthritis
hidrosadenitis suppurativa
inflammation
magnetic resonance imaging
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration