Distal Erosions and Nail Psoriasis

• Conditions: Psoriatic Arthritis
• Interventions: Radiation: HR-pQCT High resolution peripheral quantitative CT-scan

• Registration Number: NCT02813720
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11
• Status Verified: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Last Update Submitted: 2016-06-24
• Study First Posted: 2016-06-27
• Last Update Posted: 2016-06-28
• Primary Completion: 2016-08
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

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Exclusion Criteria

• Treatment by biological agents are an exclusion criteria for PsO, onycholysis and control patients.
• Pregnant women

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with peripheral PsA	HR-pQCT High resolution peripheral quantitative CT-scan	-
Patients with psoriatic nail onycholysis	HR-pQCT High resolution peripheral quantitative CT-scan	-
Patients with PsO only	HR-pQCT High resolution peripheral quantitative CT-scan	-
Healthy match control subjects	HR-pQCT High resolution peripheral quantitative CT-scan	-

Primary Outcome Measures

Name	Time	Method
distal phalangeal bone erosion of the 2 index fingers of the hand	at baseline and after 4 years of follow-up	assessment by HR-pQCT

Secondary Outcome Measures

Name	Time	Method
enthesopathy of the 2 index fingers of the hand	at baseline and after 4 years of follow-up	assessment by ultrasonography
Rheumatoid factors	Biomarkers are assessed at baseline

Trial Locations

Locations (1)

Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval; 🇫🇷 Lyon, France