NCT03668925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 7, 2018

Last Update Submit

September 12, 2018

Conditions

Keywords

spondyloarthritishidrosadenitis suppurativainflammationmagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • spondyloarthritis

    spondyloarthritis was diagnosed by a rheumatologist using the Assessment of SpondyloArthritis international Society (ASAS) criteria

    Day 0

Study Arms (2)

Group "Case"

EXPERIMENTAL

patient diagnosed with hidrosadenitis suppurativa

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

Radiation: magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement

Interventions

magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement

Group "Case"Group "control"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • for case and control: age \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

  • 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.

    PMID: 28965938BACKGROUND

MeSH Terms

Conditions

Hidradenitis SuppurativaSpondylarthritisInflammation

Interventions

Magnetic Resonance SpectroscopyWeights and Measures

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland DiseasesSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

September 13, 2018

Study Start

May 1, 2013

Primary Completion

April 1, 2014

Study Completion

September 1, 2015

Last Updated

September 13, 2018

Record last verified: 2018-08

Locations