SpondyloarthritisNCT04946539
Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis
An observational study of Spondyloarthritis and Enthesitis, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
Trial summary
The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spondyloarthritis, Enthesitis
- What is being tested?
- Ultrasonography
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2017
- 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 to 60 years
- All sexes
- Adult
Study population: Spondyloarthritis
Who may be able to join
- Spondyloarthritis patients that fulfill 2009 ASAS criteria
Who cannot join
- 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
About this study
The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.
- Conditions
- Spondyloarthritis, Enthesitis
- Being tested
- Ultrasonography
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Enthesitis assessment via ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Spondyloarthritis | Not described Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity,
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), minimum value 0, maximum value 10, higher scores mean a worse outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: between November 2016 and January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study startNov 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies 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
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunay ER, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946539
- Sponsor's protocol ID
- 83045809-604.01.02
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis
- ClinicalTrials.gov ID
- NCT04946539
- Acronym / sponsor ID
- 83045809-604.01.02
- Conditions
- Spondyloarthritis, Enthesitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 Jul 2021 (actual)
- 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.
The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spondyloarthritis | – | Diagnostic Test: Ultrasonography |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Spondyloarthritis
Key inclusion criteria (1 listed)
- Spondyloarthritis patients that fulfill 2009 ASAS criteria
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| UltrasonographyEnthesitis assessment via ultrasonography | Diagnostic test | Spondyloarthritis |
Primary outcome
Disease activity,
Time frame: between November 2016 and January 2017
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), minimum value 0, maximum value 10, higher scores mean a worse outcome
Disease activity,
Time frame: between November 2016 and January 2017
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
functionality
Time frame: between November 2016 and January 2017
Bath Ankylosing Spondylitis Functionality Index (BASFI). Minimal values 0, maximum value 100. Higher scores mean a worse outcome
to measure quality of life
Time frame: between November 2016 and January 2017
Short Form - 12 (SF-12). minimum value 0 maximum value 100. higher scores mean a worse outcome
to measure quality of life
Time frame: between November 2016 and January 2017
Ankylosing Spondylitis Quality of Life (ASQoL). minimum value 0 maximum value 18. Higher scores mean a worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis and Enthesitis, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity, (time frame: between November 2016 and January 2017). The study lists 5 primary outcomes in all. 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 1 Jul 2021.