Vulgaris PsoriasisNCT02339636
A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis
An observational study of Vulgaris Psoriasis, run by The 306 Hospital of People's Liberation Army at 1 site in China.
Trial summary
A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vulgaris Psoriasis
- What is being tested?
- PDUS examination
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both patients with psoriasis and patients with other skin diseases
Who may be able to join
- age≥18years
- patients with vulgaris psoriasis(dur
- patients with other skin diseases without musculoskeletal disorders
- no joint involvement and no clinical symptoms and signs of enthesitis and synovitis
Who cannot join
- BMI≥24
- have history of gout or arthritis or peripheral neurological disease of lower extremity or trauma
- have received any systemic therapy(i.e.NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
- pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
China1 site
306 Hospital of PLA
Beijing, 100101
jianjun liu, MD, liujianjun306@126.com
About this study
A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis
Read the detailed description
A total of 100 patients with vulgaris psoriasis and 100 age-matched controls with other skin diseases, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded PDUS evaluation. Clinical assessment included demographics, severity of psoriasis, musculoskeletal clinical examination and sport activities. PDUS evaluation consisted of the detection of grey scale (GS) synovitis and synovial PD signal in joints of extremities, GS enthesopathy and entheseal PD signal in entheses of lower limbs.
- Conditions
- Vulgaris Psoriasis
- Being tested
- PDUS examination
- Keywords
- subclinical, enthesitis, synovitis
- Medical subject headings
- Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDUS examinationOther
| Study group | Role | What they receive |
|---|---|---|
| case group | 100 patients with vulgaris psoriasi without arthritis Receives: Other: PDUS examination | |
| control group | 100 age-matched patients with other skin diseases without arthritis Receives: Other: PDUS examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subclinical enthesitis and synovitis
To investigate the incidence of subclinical enthesitis and synovitis in patients with vulgaris
Measured: one and a half year
Secondary outcomes (1)
Number of participants with Risk factors of subclinical enthesitis and synovitis
To find out predictor factors of subclinical enthesitis and synovitis in patients with vulgaris psoriasis
Measured: one and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionSep 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 Vulgaris PsoriasisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The 306 Hospital of People's Liberation Army
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianjun Liu, M.D., Principal investigator, The 306 Hospital of People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339636
- Sponsor's protocol ID
- 306PLA-002
- Status last verified
- Aug 2013
- First submitted
- 13 Jan 2015
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis
- ClinicalTrials.gov ID
- NCT02339636
- Acronym / sponsor ID
- 306PLA-002
- Conditions
- Vulgaris Psoriasis
- Keywords
- subclinical, enthesitis, synovitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The 306 Hospital of People's Liberation ArmyUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Jan 2015 (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.
A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis
Detailed description
A total of 100 patients with vulgaris psoriasis and 100 age-matched controls with other skin diseases, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded PDUS evaluation. Clinical assessment included demographics, severity of psoriasis, musculoskeletal clinical examination and sport activities. PDUS evaluation consisted of the detection of grey scale (GS) synovitis and synovial PD signal in joints of extremities, GS enthesopathy and entheseal PD signal in entheses of lower limbs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: PDUS examination100 patients with vulgaris psoriasi without arthritis |
| control group | – | Other: PDUS examination100 age-matched patients with other skin diseases without arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both patients with psoriasis and patients with other skin diseases
Key inclusion criteria (4 listed)
- age≥18years
- patients with vulgaris psoriasis(dur
- patients with other skin diseases without musculoskeletal disorders
- no joint involvement and no clinical symptoms and signs of enthesitis and synovitis
Key exclusion criteria (4 listed)
- BMI≥24
- have history of gout or arthritis or peripheral neurological disease of lower extremity or trauma
- have received any systemic therapy(i.e.NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
- pregnant or breast-feeding
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 |
|---|---|---|
| PDUS examination | Other | case group, control group |
Primary outcome
Incidence of subclinical enthesitis and synovitis
Time frame: one and a half year
To investigate the incidence of subclinical enthesitis and synovitis in patients with vulgaris
1 secondary outcome
Number of participants with Risk factors of subclinical enthesitis and synovitis
Time frame: one and a half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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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.
Jianjun Liu, M.D. principal investigator
The 306 Hospital of People's Liberation Army
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 Vulgaris Psoriasis, run by The 306 Hospital of People's Liberation Army 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 4 inclusion and 4 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 15 Jan 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of subclinical enthesitis and synovitis (time frame: one and a half year). 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 15 Jan 2015.