A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis

Vulgaris Psoriasis Clinical Trial

Official title:

A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02339636
• Other study ID #: 306PLA-002
• Status: Not yet recruiting
• Phase: N/A
• First received: January 13, 2015
• Last updated: January 14, 2015
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2013
• Source: The 306 Hospital of People's Liberation Army
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psoriasis
• Synovitis
• Vulgaris Psoriasis

Intervention

Other:
• PDUS examination

Locations

Country	Name	City	State
China	306 Hospital of PLA	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The 306 Hospital of People's Liberation Army

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of subclinical enthesitis and synovitis	To investigate the incidence of subclinical enthesitis and synovitis in patients with vulgaris	one and a half year	No
Secondary	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	one and a half year	No