NCT02962271

Brief 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. 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.

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
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

November 3, 2016

Last Update Submit

November 9, 2016

Conditions

Keywords

Musculoskeletal UltrasoundPsoriatic ArthritisEnthesopathy

Outcome Measures

Primary Outcomes (1)

  • The rate of enthesopathy comparison between psoriatic arthritis(PsA) and psoriasis(Ps) as assessed by SPSS v17.0

    up to 10 months

Secondary Outcomes (1)

  • The potential risk factors of Ps for PsA as assessed by SPSS v17.0

    up to 10 months

Study Arms (2)

Psoriatic Arthritis

Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed

Device: Musculoskeletal Ultrasound

Psoriasis

Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed

Device: Musculoskeletal Ultrasound

Interventions

Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed

PsoriasisPsoriatic Arthritis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Other systemic rheumatic diseases or malignant neoplasms.
  • Peripheral neuropathy of lower extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

EnthesopathyArthritis, Psoriatic

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jian Zhu

    Department of Rheumatology,PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 11, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

November 11, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

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

Locations