Distal Erosions and Nail Psoriasis

Psoriatic Arthritis Clinical Trial

— PSUPSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02813720
• Other study ID #: 69HCL16_0202
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2016
• Last updated: June 24, 2016
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: Cyrille Confavreux, MD PHD
• Phone: (0)4 72 11 74 79
• Email: cyrille.confavreux[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 exclusion criteria for PsO, onycholysis and control patients.

• Pregnant women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Radiation:
• HR-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.

Locations

Country	Name	City	State
France	Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	distal phalangeal bone erosion of the 2 index fingers of the hand	assessment by HR-pQCT	at baseline and after 4 years of follow-up	No
Secondary	enthesopathy of the 2 index fingers of the hand	assessment by ultrasonography	at baseline and after 4 years of follow-up	No
Secondary	Rheumatoid factors		Biomarkers are assessed at baseline	No