- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02813720
Distal Erosions and Nail Psoriasis (PSUPSO)
Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69003
- Recruiting
- Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval
-
Contact:
- Cyrille Confavreux, MD PHD
- Phone Number: +33 (0)4 72 11 74 79
- Email: cyrille.confavreux@chu-lyon.fr
-
Contact:
- Céline Coutisson, clinical research assistant
- Phone Number: +33 (0)4 72 11 74 46
- Email: centre.prevention@wanadoo.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with peripheral PsA
|
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
|
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
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at baseline and after 4 years of follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
enthesopathy of the 2 index fingers of the hand
Time Frame: at baseline and after 4 years of follow-up
|
assessment by ultrasonography
|
at baseline and after 4 years of follow-up
|
Rheumatoid factors
Time Frame: Biomarkers are assessed at baseline
|
Biomarkers are assessed at baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cyrille Confavreux, MD PHD, Hospices Civils de Lyon, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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