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Distal Erosions and Nail Psoriasis

Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02813720
Acronym
PSUPSO
Enrollment
104
Registered
2016-06-27
Start date
2013-11-30
Completion date
2016-09-30
Last updated
2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Keywords

Erosions, Onycholysis, HR-pQCT, Psoriatic arthritis

Brief summary

Nearly 30% of patients with cutaneous psoriasis (PsO) developed psoriatic arthritis (PsA). Among these patients 20 % will have severe destructive arthritis. The risk of developing PsA is significantly higher in patients with nail involvement (OR = 2.24; 95% CI \[1.26-3.98\]). The risk is particularly high for the peripheral form of PsA and onycholysis (OR=2.80; 95% CI \[1.34-5.85\]). Thus the investigators wanted to test the hypothesis that onycholysis, in patients without PsA, is a potential clinical marker of subclinical distal enthesopathy and, by extension, of bone micro-structural alterations. Patients and Methods The investigators will recruit 4 groups of subjects: 1. Patients with peripheral PsA, 2. Patients with psoriatic nail onycholysis, 3. Patients with PsO only 4. Healthy match control subjects. The investigators will assess the presence of enthesopathy by ultrasonography and bone structural damages (by HR-pQCT) in all subjects at baseline and 4 years.

Interventions

RADIATIONHR-pQCT High resolution peripheral quantitative CT-scan

HR-pQCT is a powerful device providing low dose irradiation already used in bone field. It is a high resolution tool (voxel size=82µm) that the investigators adapted to look after the distal joint involved by onycholysis. An anteroposterior scout view is used to define the region of interest (ROI), which spanned from the top of the distal phalange to the distal part of the intermediate phalange in order to contain the distal joint of the target finger. Images are then analysed for erosions, osteophytes and volumetric bone mineral density.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* adults over 18 years and until 65 years * both gender * covered by the French National Insurance * subjects entering one of the 4 groups.

Exclusion criteria

* Treatment by biological agents are an

Design outcomes

Primary

MeasureTime frameDescription
distal phalangeal bone erosion of the 2 index fingers of the handat baseline and after 4 years of follow-upassessment by HR-pQCT

Secondary

MeasureTime frameDescription
enthesopathy of the 2 index fingers of the handat baseline and after 4 years of follow-upassessment by ultrasonography
Rheumatoid factorsBiomarkers are assessed at baseline

Countries

France

Contacts

Primary ContactCyrille Confavreux, MD PHD
cyrille.confavreux@chu-lyon.fr(0)4 72 11 74 79
Backup ContactCéline Coutisson, clinical research assistant
centre.prevention@wanadoo.fr(0)4 72 11 74 46

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026