Psoriatic ArthritisPSUPSONCT02813720
Distal Erosions and Nail Psoriasis
An observational study of Psoriatic Arthritis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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]). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- HR-pQCT High resolution peripheral quantitative CT-scan
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- adults over 18 years and until 65 years
- both gender
- covered by the French National Insurance
- subjects entering one of the 4 groups.
Who cannot join
- Treatment by biological agents are an exclusion criteria for PsO, onycholysis and control patients.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Céline Coutisson, clinical research assistant contact
France1 site, 1 recruiting
- Recruiting
Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval
Lyon, 69003
Cyrille Confavreux, MD PHD, (0)4 72 11 74 79 ext. +33, cyrille.confavreux@chu-lyon.fr
Céline Coutisson, clinical research assistant, (0)4 72 11 74 46 ext. +33, centre.prevention@wanadoo.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Psoriatic Arthritis
- Being tested
- HR-pQCT High resolution peripheral quantitative CT-scan
- Keywords
- Erosions, Onycholysis, HR-pQCT, Psoriatic arthritis
- Medical subject headings
- Arthritis, Psoriatic, Onycholysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCT High resolution peripheral quantitative CT-scanRadiation
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 group | Role | What they receive |
|---|---|---|
| Patients with peripheral PsA | Not described Receives: Radiation: HR-pQCT High resolution peripheral quantitative CT-scan | |
| Patients with psoriatic nail onycholysis | Not described Receives: Radiation: HR-pQCT High resolution peripheral quantitative CT-scan | |
| Patients with PsO only | Not described Receives: Radiation: HR-pQCT High resolution peripheral quantitative CT-scan | |
| Healthy match control subjects | Not described Receives: Radiation: HR-pQCT High resolution peripheral quantitative CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
distal phalangeal bone erosion of the 2 index fingers of the hand
assessment by HR-pQCT
Measured: at baseline and after 4 years of follow-up
Secondary outcomes (2)
enthesopathy of the 2 index fingers of the hand
assessment by ultrasonography
Measured: at baseline and after 4 years of follow-up
Rheumatoid factors
Measured: Biomarkers are assessed at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startNov 2013
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrille Confavreux, MD PHD, Principal investigator, Hospices Civils de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813720
- Sponsor's protocol ID
- 69HCL16_0202
- Acronym
- PSUPSO
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
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). 2021 Mar 2;60(3):1176-1184. doi: 10.1093/rheumatology/keaa415.
PubMed 32885241
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis
- ClinicalTrials.gov ID
- NCT02813720
- Acronym / sponsor ID
- PSUPSO / 69HCL16_0202
- Conditions
- Psoriatic Arthritis
- Keywords
- Erosions, Onycholysis, HR-pQCT, Psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral PsA | – | Radiation: HR-pQCT High resolution peripheral quantitative CT-scan |
| Patients with psoriatic nail onycholysis | – | Radiation: HR-pQCT High resolution peripheral quantitative CT-scan |
| Patients with PsO only | – | Radiation: HR-pQCT High resolution peripheral quantitative CT-scan |
| Healthy match control subjects | – | Radiation: HR-pQCT High resolution peripheral quantitative CT-scan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- adults over 18 years and until 65 years
- both gender
- covered by the French National Insurance
- subjects entering one of the 4 groups.
Key exclusion criteria (2 listed)
- Treatment by biological agents are an exclusion criteria for PsO, onycholysis and control patients.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR-pQCT High resolution peripheral quantitative CT-scanHR-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. | Radiation | Healthy match control subjects, Patients with PsO only, Patients with peripheral PsA, Patients with psoriatic nail onycholysis |
Primary outcome
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
2 secondary outcomes
enthesopathy of the 2 index fingers of the hand
Time frame: at baseline and after 4 years of follow-up
Rheumatoid factors
Time frame: Biomarkers are assessed at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Derived from this study: PubMed 32885241Villani 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). 2021 Mar 2;60(3):1176-1184. doi: 10.1093/rheumatology/keaa415.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline Coutisson, clinical research assistant contact
Cyrille Confavreux, MD PHD principal investigator
Hospices Civils de Lyon, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cyrille Confavreux, MD PHD ((0)4 72 11 74 79 ext. +33, cyrille.confavreux@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distal phalangeal bone erosion of the 2 index fingers of the hand (time frame: at baseline and after 4 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.