Axial SpondyloarthritisNCT05942976
Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy
An observational study of Axial Spondyloarthritis and Rheumatoid Arthritis, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the sonographic differences in entheses in patients with Rheumatoid arthritis and Axial Spondyloarthropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis, Rheumatoid Arthritis, Enthesitis
- What is being tested?
- ULTRASOUND
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2023to 15 Aug 2023
- How long will I take part?
- 2 Months
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria, axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria and healthy controls with no history of rheumatic diseases.
Who may be able to join
- Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria,
- axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria
- healthy controls with no history of rheumatic diseases.
Who cannot join
- history of limb trauma and surgery in the last 3 months,
- metabolic disease (diabetes mellitus, hypothyroidism),
- malignant neoplasm,
- limitation of range of motion in the extremity,
- those who have received corticosteroid injections in the last 3 months,
- uncontrollable fibromyalgia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Resarch Hospital
Istanbul
About this study
Official title: Ultrasonographic Differences in Entheses in Rheumatoid Arthritis and Axial Spondyloarthropathy Patients
The aim of this study is to investigate the sonographic differences in entheses in patients with Rheumatoid arthritis and Axial Spondyloarthropathy.
Read the detailed description
After recording the demographic data of the patients; 5 enthesis regions 5 enthesis sites were evaluated bilaterally as ''tricipital tendon (TT), quadricipital tendon (QT), proximal patellar tendon (PPT), distal patellar tendon (DPT), achilles tendon (AT)'' will be sonographically evaluated and the presence of hypoechogenicity , tendon thickness increase, power Doppler activity, erosion, presence of entezophyte/calcification will be investigated. The differences between the groups will then be compared.
- Being tested
- ULTRASOUND
- Keywords
- Axial Spondyloarthritis,, Rheumatoid Arthritis, Enthesitis, Ultrasound
- Medical subject headings
- Axial Spondyloarthritis, Arthritis, Rheumatoid, Enthesopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASOUNDOther
10 enthesis areas will be evaluated in 20 minutes with ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| group 1: axial spondyloarthritis | SpA patients identified according to the Assessment of Spondyloarthritis classification criteria Receives: Other: ULTRASOUND | |
| group 2: Rheumatoid arthritis | RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria Receives: Other: ULTRASOUND | |
| group:3 Healthy Control | healthy controls with no history of rheumatic diseases Receives: Other: ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound enthesis differences between the groups
triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores differences between the groups
Measured: 2 months
The relationship between ultrasound findings and disease parameters
The relationship between triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores and Clinical disease activity index and BASDAI
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start16 Jun 2023
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Tayyip Dede, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942976
- Sponsor's protocol ID
- 16/09/2022; 2011-KAEK-50;288
- Status last verified
- Sep 2023
- First submitted
- 27 Jun 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Differences in Entheses in Rheumatoid Arthritis and Axial Spondyloarthropathy Patients
- ClinicalTrials.gov ID
- NCT05942976
- Acronym / sponsor ID
- 16/09/2022; 2011-KAEK-50;288
- Keywords
- Axial Spondyloarthritis,, Rheumatoid Arthritis, Enthesitis, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 12 Jul 2023 (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 this study is to investigate the sonographic differences in entheses in patients with Rheumatoid arthritis and Axial Spondyloarthropathy.
Detailed description
After recording the demographic data of the patients; 5 enthesis regions 5 enthesis sites were evaluated bilaterally as ''tricipital tendon (TT), quadricipital tendon (QT), proximal patellar tendon (PPT), distal patellar tendon (DPT), achilles tendon (AT)'' will be sonographically evaluated and the presence of hypoechogenicity , tendon thickness increase, power Doppler activity, erosion, presence of entezophyte/calcification will be investigated. The differences between the groups will then be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1: axial spondyloarthritis | – | Other: ULTRASOUNDSpA patients identified according to the Assessment of Spondyloarthritis classification criteria |
| group 2: Rheumatoid arthritis | – | Other: ULTRASOUNDRA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria |
| group:3 Healthy Control | – | Other: ULTRASOUNDhealthy controls with no history of rheumatic diseases |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria, axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria and healthy controls with no history of rheumatic diseases.
Key inclusion criteria (3 listed)
- Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria,
- axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria
- healthy controls with no history of rheumatic diseases.
Key exclusion criteria (6 listed)
- history of limb trauma and surgery in the last 3 months,
- metabolic disease (diabetes mellitus, hypothyroidism),
- malignant neoplasm,
- limitation of range of motion in the extremity,
- those who have received corticosteroid injections in the last 3 months,
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 |
|---|---|---|
| ULTRASOUND10 enthesis areas will be evaluated in 20 minutes with ultrasound. | Other | group 1: axial spondyloarthritis, group 2: Rheumatoid arthritis, group:3 Healthy Control |
Primary outcome
Ultrasound enthesis differences between the groups
Time frame: 2 months
triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores differences between the groups
The relationship between ultrasound findings and disease parameters
Time frame: 2 months
The relationship between triceps tendon, quadriceps tendon, proximal patellar tendon, distal patellar tendon and achilles tendons enthesitis scores and Clinical disease activity index and BASDAI
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 6 Sep 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis and Rheumatoid Arthritis, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Ultrasound enthesis differences between the groups (time frame: 2 months). The study lists 2 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 6 Sep 2023.