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
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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:
- Patients with peripheral PsA,
- Patients with psoriatic nail onycholysis,
- Patients with PsO only
- 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 |
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. |
- 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
- 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 ]
Biospecimen Retention: Samples With DNA

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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 |
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

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
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 |
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 |
Principal Investigator: | Cyrille Confavreux, MD PHD | Hospices Civils de Lyon, France |
Responsible Party: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT02813720 |
Other Study ID Numbers: |
69HCL16_0202 |
First Posted: | June 27, 2016 Key Record Dates |
Last Update Posted: | June 28, 2016 |
Last Verified: | June 2016 |
Erosions Onycholysis HR-pQCT Psoriatic arthritis |
Arthritis Arthritis, Psoriatic Psoriasis Joint Diseases Musculoskeletal Diseases Skin Diseases, Papulosquamous |
Skin Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases |