NCT04946539

Brief Summary

The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Status
completed

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

November 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 22, 2021

Last Update Submit

June 29, 2021

Conditions

SpondyloarthritisEnthesitis

Outcome Measures

Primary Outcomes (5)

  • Disease activity,

    BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), minimum value 0, maximum value 10, higher scores mean a worse outcome

    between November 2016 and January 2017

  • Disease activity,

    Ankylosing Spondylitis Disease Activity Score (ASDAS). It is calculated by adding CRP (ASDAS-CRP) or ESR (ASDAS-ESR). there is no spesific minimal and maximum value because it depends on CRP or ESR value. Higher scores mean a worse outcome

    between November 2016 and January 2017

  • functionality

    Bath Ankylosing Spondylitis Functionality Index (BASFI). Minimal values 0, maximum value 100. Higher scores mean a worse outcome

    between November 2016 and January 2017

  • to measure quality of life

    Short Form - 12 (SF-12). minimum value 0 maximum value 100. higher scores mean a worse outcome

    between November 2016 and January 2017

  • to measure quality of life

    Ankylosing Spondylitis Quality of Life (ASQoL). minimum value 0 maximum value 18. Higher scores mean a worse outcome

    between November 2016 and January 2017

Study Arms (1)

Spondyloarthritis

Diagnostic Test: Ultrasonography

Interventions

UltrasonographyDIAGNOSTIC_TEST

Enthesitis assessment via ultrasonography

Spondyloarthritis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Spondyloarthritis

You may qualify if:

  • Spondyloarthritis patients that fulfill 2009 ASAS criteria

You may not qualify if:

  • history of elbow, ankle or knee surgery, local injection at the examination sites within the six weeks, peripheral neuropathy, infection and wound at examination site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylarthritis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

June 22, 2021

First Posted

July 1, 2021

Study Start

November 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

July 1, 2021

Record last verified: 2021-06