NCT02339636

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 15, 2015

Status Verified

August 1, 2013

Enrollment Period

1.5 years

First QC Date

January 13, 2015

Last Update Submit

January 14, 2015

Conditions

Vulgaris Psoriasis

Keywords

subclinical, enthesitis, synovitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of subclinical enthesitis and synovitis

    To investigate the incidence of subclinical enthesitis and synovitis in patients with vulgaris

    one and a half year

Secondary Outcomes (1)

  • Number of participants with Risk factors of subclinical enthesitis and synovitis

    one and a half year

Study Arms (2)

case group

100 patients with vulgaris psoriasi without arthritis

Other: PDUS examination

control group

100 age-matched patients with other skin diseases without arthritis

Other: PDUS examination

Interventions

PDUS examinationOTHER
case groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both patients with psoriasis and patients with other skin diseases

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

306 Hospital of PLA

Beijing, 100101, China

Location

MeSH Terms

Conditions

Synovitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Jianjun Liu, M.D.

    The 306 Hospital of People's Liberation Army

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 15, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

January 15, 2015

Record last verified: 2013-08

Locations

CN(1)