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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

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.

Condition or disease Intervention/treatment
Psoriatic Arthritis Radiation: HR-pQCT High resolution peripheral quantitative CT-scan

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis
Study Start Date : November 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016


Group/Cohort Intervention/treatment
Patients with peripheral PsA 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.


Patients with psoriatic nail onycholysis 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.


Patients with PsO only 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.


Healthy match control subjects 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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. enthesopathy of the 2 index fingers of the hand [ Time Frame: at baseline and after 4 years of follow-up ]
    assessment by ultrasonography

  2. Rheumatoid factors [ Time Frame: Biomarkers are assessed at baseline ]

Biospecimen Retention:   Samples With DNA
Urine Serum and plasma Whole blood


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813720


Contacts
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Contact: Cyrille Confavreux, MD PHD (0)4 72 11 74 79 ext +33 cyrille.confavreux@chu-lyon.fr
Contact: Céline Coutisson, clinical research assistant (0)4 72 11 74 46 ext +33 centre.prevention@wanadoo.fr

Locations
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France
Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval Recruiting
Lyon, France, 69003
Contact: Cyrille Confavreux, MD PHD    (0)4 72 11 74 79 ext +33    cyrille.confavreux@chu-lyon.fr   
Contact: Céline Coutisson, clinical research assistant    (0)4 72 11 74 46 ext +33    centre.prevention@wanadoo.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Cyrille Confavreux, MD PHD Hospices Civils de Lyon, France

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02813720     History of Changes
Other Study ID Numbers: 69HCL16_0202
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by Hospices Civils de Lyon:
Erosions
Onycholysis
HR-pQCT
Psoriatic arthritis

Additional relevant MeSH terms:
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Arthritis
Psoriasis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases