Clinical trial NCT02813720: Distal Erosions and Nail Psoriasis
Official title: Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriatic Arthritis
Keywords: Erosions
Onycholysis
HR-pQCT
Psoriatic arthritis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PSUPSO is a prospective study. Diagnosis of PsA is based on the CASPAR criteria (Taylor 2006). PASI, NAPSI and NAPSI target are recorded. PsO patients are gender and age matched with onycholysis patients patients.

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.


Eligibility criteria: 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

Primary outcomes:
measure: distal phalangeal bone erosion of the 2 index fingers of the hand
timeFrame: at baseline and after 4 years of follow-up
Secondary outcomes:
measure: enthesopathy of the 2 index fingers of the hand
timeFrame: at baseline and after 4 years of follow-up
measure: Rheumatoid factors
timeFrame: Biomarkers are assessed at baseline
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval
Study officials:
affiliation: Hospices Civils de Lyon, France
name: Cyrille Confavreux, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villani AP, Boutroy S, Coutisson C, Carlier MC, Barets L, Marotte H, Richert B, Chapurlat RD, Jullien D, Confavreux CB. Distal phalangeal bone erosions observed by HR-pQCT in patients with psoriatic onycholysis. Rheumatology (Oxford). 2021 Mar 2;60(3):1176-1184. doi: 10.1093/rheumatology/keaa415.