EnthesopathyNCT02962271
Comparation of Ultrasonic Imaging of Enthesopathy in Patients With Psoriatic Arthritis and Psoriasis
An observational study of Enthesopathy, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked with rash of psoriasis, but there's still great controversy regarding the exact relationship between them. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Enthesopathy
- What is being tested?
- Musculoskeletal Ultrasound
- Type of treatment
- Medical device
- How many people
- 187 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 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: A series of 44 patients with PsA, 44 age- and sex-matched patients of Ps and 44 HCs consecutively admitted from the outpatients clinic and ward from January 2016 to September 2016.
Who may be able to join
- Clinical diagnosis of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis or osteoarthritis.
- Body Mass Index (BMI)<30 kg/m2.
- Absence of local glucocorticoid or other drugs injection or surgical treatment for entheses scanned in the previous 6 weeks prior to clinical and musculoskeletal ultrasound (MSUS) evaluation.
Who cannot join
- Other systemic rheumatic diseases or malignant neoplasms.
- Peripheral neuropathy of lower extremity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100000
Feng Huang, 8610-55499114, frankfhuang@126.com
About this study
Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked with rash of psoriasis, but there's still great controversy regarding the exact relationship between them. Our study is to investigate the characteristics and differences of the ultrasonic imaging of enthesopathy in the lower extremity in patients with PsA and Ps, to explore the risk factors of Ps developing into PsA in the long term course.
Read the detailed description
As one of the most common chronic inflammatory skin diseases, psoriasis(Ps) can be intimately associated to psoriatic arthritis (PsA), affecting approximately 1% to 2% of the world's population. About 30% of them will develop into PsA with serious impact on their health-related quality of life.
PsA, characterised by different subsets with varying degree of severity, is a chronic, complicated inflammatory disease.Enthesitis is the prevalent and distinctive feature of PsA.
Musculoskeletal Ultrasound (MSUS) is a valid noninvasive modality, essential to evaluate entheses thickness, enthesophytes, bursitis and bone erosions as well as to disclose vascularisation on tendons through power doppler (PD) assessment. In recent years, more and more attention has been paid to the diagnosis and management of Ps and PsA, owing to its discrimination of identifying subclinical entheses and joint changes.
- Conditions
- Enthesopathy
- Being tested
- Musculoskeletal Ultrasound
- Keywords
- Musculoskeletal Ultrasound, Psoriatic Arthritis, Enthesopathy
- Medical subject headings
- Enthesopathy, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal UltrasoundDevice
Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Arthritis | Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed Receives: Device: Musculoskeletal Ultrasound | |
| Psoriasis | Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed Receives: Device: Musculoskeletal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of enthesopathy comparison between psoriatic arthritis(PsA) and psoriasis(Ps) as assessed by SPSS v17.0
Measured: up to 10 months
Secondary outcomes (1)
The potential risk factors of Ps for PsA as assessed by SPSS v17.0
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnthesopathyStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhu, Chinese PLA General Hospital
- Investigators
- Jian Zhu, Principal investigator, Department of Rheumatology,PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962271
- Sponsor's protocol ID
- ChinaPLAGH-PsA
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All individual participant data (IPD) are to be shared with other researchers, whenever it will be available, and it may be obtained by requesting from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparation of Ultrasonic Imaging of Enthesopathy in Patients With Psoriatic Arthritis and Psoriasis
- ClinicalTrials.gov ID
- NCT02962271
- Acronym / sponsor ID
- ChinaPLAGH-PsA
- Conditions
- Enthesopathy
- Keywords
- Musculoskeletal Ultrasound, Psoriatic Arthritis, Enthesopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Nov 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.
Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked with rash of psoriasis, but there's still great controversy regarding the exact relationship between them. Our study is to investigate the characteristics and differences of the ultrasonic imaging of enthesopathy in the lower extremity in patients with PsA and Ps, to explore the risk factors of Ps developing into PsA in the long term course.
Detailed description
As one of the most common chronic inflammatory skin diseases, psoriasis(Ps) can be intimately associated to psoriatic arthritis (PsA), affecting approximately 1% to 2% of the world's population. About 30% of them will develop into PsA with serious impact on their health-related quality of life.
PsA, characterised by different subsets with varying degree of severity, is a chronic, complicated inflammatory disease.Enthesitis is the prevalent and distinctive feature of PsA.
Musculoskeletal Ultrasound (MSUS) is a valid noninvasive modality, essential to evaluate entheses thickness, enthesophytes, bursitis and bone erosions as well as to disclose vascularisation on tendons through power doppler (PD) assessment. In recent years, more and more attention has been paid to the diagnosis and management of Ps and PsA, owing to its discrimination of identifying subclinical entheses and joint changes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis | – | Device: Musculoskeletal UltrasoundMusculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed |
| Psoriasis | – | Device: Musculoskeletal UltrasoundMusculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A series of 44 patients with PsA, 44 age- and sex-matched patients of Ps and 44 HCs consecutively admitted from the outpatients clinic and ward from January 2016 to September 2016.
Key inclusion criteria (3 listed)
- Clinical diagnosis of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis or osteoarthritis.
- Body Mass Index (BMI)<30 kg/m2.
- Absence of local glucocorticoid or other drugs injection or surgical treatment for entheses scanned in the previous 6 weeks prior to clinical and musculoskeletal ultrasound (MSUS) evaluation.
Key exclusion criteria (2 listed)
- Other systemic rheumatic diseases or malignant neoplasms.
- Peripheral neuropathy of lower extremity.
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 |
|---|---|---|
| Musculoskeletal UltrasoundMusculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed | Device | Psoriasis, Psoriatic Arthritis |
Primary outcome
The rate of enthesopathy comparison between psoriatic arthritis(PsA) and psoriasis(Ps) as assessed by SPSS v17.0
Time frame: up to 10 months
1 secondary outcome
The potential risk factors of Ps for PsA as assessed by SPSS v17.0
Time frame: up to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) are to be shared with other researchers, whenever it will be available, and it may be obtained by requesting from the principal investigator
Related trials for Enthesopathy
RecruitingObservational study
Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO)
Hypophosphatasia
Recruiting
Hyaluronic Acid Versus Platelet-Rich Plasma for Chronic Tendinopathy and Enthesopathy
Tendinopathy, Enthesopathy
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.
Jian Zhu principal investigator
Department of Rheumatology,PLA General Hospital
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 Enthesopathy, run by Chinese PLA General Hospital at 1 site in China.
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 3 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 11 Nov 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 China. 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 Fei Sun (86-01-55499314, sunfeighy8911@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of enthesopathy comparison between psoriatic arthritis(PsA) and psoriasis(Ps) as assessed by SPSS v17.0 (time frame: up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2016.