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Distal Erosions and Nail Psoriasis (PSUPSO)

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ClinicalTrials.gov Identifier: NCT02813720
Recruitment Status : Unknown
Verified June 2016 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : June 27, 2016
Last Update Posted : June 28, 2016
Sponsor:
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
Change History
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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