Clinical Trial: Distal Erosions and Nail Psoriasis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis
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:
- Patients with peripheral PsA,
- Patients with psoriatic nail onycholysis,
- Patients with PsO only
- 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 Summary:
Sponsor: Hospices Civils de Lyon
Current Primary Outcome: distal phalangeal bone erosion of the 2 index fingers of the hand [ Time Frame: at baseline and after 4 years of follow-up ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- enthesopathy of the 2 index fingers of the hand [ Time Frame: at baseline and after 4 years of follow-up ]assessment by ultrasonography
- Rheumatoid factors [ Time Frame: Biomarkers are assessed at baseline ]
Original Secondary Outcome: Same as current
Information By: Hospices Civils de Lyon
Dates:
Date Received: June 22, 2016
Date Started: November 2013
Date Completion: September 2016
Last Updated: June 24, 2016
Last Verified: June 2016
