Distal Erosions and Nail Psoriasis (PSUPSO)

• ClinicalTrials.gov Identifier: NCT02813720
• Recruitment Status: Unknown
• First Posted: June 27, 2016
• Last Update Posted: June 28, 2016
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Tracking Information

• First Submitted Date: June 22, 2016
• First Posted Date: June 27, 2016
• Last Update Posted Date: June 28, 2016
• Study Start Date: November 2013
• Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 22, 2016)

distal phalangeal bone erosion of the 2 index fingers of the hand [ Time Frame: at baseline and after 4 years of follow-up ]

assessment by HR-pQCT

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 22, 2016)

• 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Urine Serum and plasma Whole blood

• 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.
• Condition: 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.

Study Groups/Cohorts

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

• Publications *: 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). 2020 Sep 4. pii: keaa415. doi: 10.1093/rheumatology/keaa415. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 22, 2016): 104
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2016
• Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02813720
• Other Study ID Numbers: 69HCL16_0202
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hospices Civils de Lyon
• Study Sponsor: Hospices Civils de Lyon
• Collaborators: Not Provided

Investigators

• Principal Investigator: Cyrille Confavreux, MD PHD; Hospices Civils de Lyon, France

• PRS Account: Hospices Civils de Lyon
• Verification Date: June 2016