Ankylosing SpondylitisNCT06564155
Inturlekin L33 in Ankylosing Spondylities Patients and Its Relation to Subclinical Atherosclerosis
An observational study of Ankylosing Spondylitis, run by Assiut University.
Trial summary
detect level of Inturlekin 33 in ankylosing spondyilits patient measure CIMT (carotid intima media thickness ) by carotid duplex to detect subclinical atherosclerosis in ankylosing spondyitis patients detect the relation between IL33 and subclinical atherosclerosis in Ankylosinig Spondylitis patients Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- carotid duplex
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * patient diagnosed as Ankylosing Spondylitis according to ASAS 2009 * Age (20-40)
Who may be able to join
- patient diagnosed as Ankylosing Spondylitis
- Age (20-40)
Who cannot join
- Patients with other rheumatic diseases/other SPA types
- Participants with history of CVD event in past or present
- Patient experiencing cardiovascular revascularization surgery or cerebrovascular disorder within past 6 months.
- Patient with other risk factor for atherosclerosis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Inturlekin 33 in Ankylosing Spondylitis Patients and Its Relationship to Subclinical Atherosclerosis
detect level of Inturlekin 33 in ankylosing spondyilits patient
measure CIMT (carotid intima media thickness ) by carotid duplex to detect subclinical atherosclerosis in ankylosing spondyitis patients
detect the relation between IL33 and subclinical atherosclerosis in Ankylosinig Spondylitis patients
Read the detailed description
Ankylosing spondylitis (AS), a type of SpA, is an autoimmune disease that mainly involves, sacroiliac joints (SIJs) and their adjacent soft tissues, such as tendons and ligaments. The main clinical manifestations include back pain and progressive spinal rigidity as well as inflammation of the hips, shoulders, peripheral joints and fingers/toes. In addition, there are extra-articular manifestations.
Cardiovascular disease has become the first cause of death for patients with ankylosing spondylitis (AS).
Patients with ankylosing spondylitis (AS) have an increased cardiovascular morbidity and mortality . Accelerated atherosclerosis caused by a systemic inflammatory response has been reported to be an important risk factor for increased cardiovascular risk for autoimmune diseases.
Interleukin (IL)-33 is a cytokine belonging to the IL-1 family and was recently identified as a ligand for ST2, .the serum levels of IL-33/sST2 were remarkably higher in the patients with AS than the healthy groups .
Pervious studies confirm the importance of IL-33/ST2 axis in the process of atherosclerosis, and indicate its ambiguous function in immune response, whether as proinflammatory cytokine in advanced atherosclerotic lesions, or as profibrotic, in early lesions.
Previous study shows increased CIMT in AS patients without traditional cardiovascular risk factors compared to healthy controls.
- Conditions
- Ankylosing Spondylitis
- Being tested
- carotid duplex
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid duplexDevice
measure Carotid intima media thickness
| Study group | Role | What they receive |
|---|---|---|
| ankylosing spondylities patients | detect level of IL33 in serum of AS patients
measure carotid intima media thickness by caroid dupex Receives: Device: carotid duplex | |
| control persons | detect level of IL33 in serum of normal control group
measure carotid intima media thickness by caroid dupex Receives: Device: carotid duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect level of IL33 in AS patients
measure level of IL33 in the serum of AS patients measure caroid intima media thickness CIMT in AS patients
Measured: 3 years
Secondary outcomes (1)
detect the reation between IL33 and subclinical atherosclerosis in AS patients
measure caroid intima media thickness CIMT in AS patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Hussein AbuAli, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564155
- Sponsor's protocol ID
- IL33 in Ankylosing spondylites
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li GX, Wang S, Duan ZH, Zeng Z, Pan FM. Serum levels of IL-33 and its receptor ST2 are elevated in patients with ankylosing spondylitis. Scand J Rheumatol. 2013;42(3):226-31. doi: 10.3109/03009742.2012.735700. Epub 2013 Feb 15.
PubMed 23409750
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inturlekin 33 in Ankylosing Spondylitis Patients and Its Relationship to Subclinical Atherosclerosis
- ClinicalTrials.gov ID
- NCT06564155
- Acronym / sponsor ID
- IL33 in Ankylosing spondylites
- Conditions
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2024 (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.
detect level of Inturlekin 33 in ankylosing spondyilits patient
measure CIMT (carotid intima media thickness ) by carotid duplex to detect subclinical atherosclerosis in ankylosing spondyitis patients
detect the relation between IL33 and subclinical atherosclerosis in Ankylosinig Spondylitis patients
Detailed description
Ankylosing spondylitis (AS), a type of SpA, is an autoimmune disease that mainly involves, sacroiliac joints (SIJs) and their adjacent soft tissues, such as tendons and ligaments. The main clinical manifestations include back pain and progressive spinal rigidity as well as inflammation of the hips, shoulders, peripheral joints and fingers/toes. In addition, there are extra-articular manifestations.
Cardiovascular disease has become the first cause of death for patients with ankylosing spondylitis (AS).
Patients with ankylosing spondylitis (AS) have an increased cardiovascular morbidity and mortality . Accelerated atherosclerosis caused by a systemic inflammatory response has been reported to be an important risk factor for increased cardiovascular risk for autoimmune diseases.
Interleukin (IL)-33 is a cytokine belonging to the IL-1 family and was recently identified as a ligand for ST2, .the serum levels of IL-33/sST2 were remarkably higher in the patients with AS than the healthy groups .
Pervious studies confirm the importance of IL-33/ST2 axis in the process of atherosclerosis, and indicate its ambiguous function in immune response, whether as proinflammatory cytokine in advanced atherosclerotic lesions, or as profibrotic, in early lesions.
Previous study shows increased CIMT in AS patients without traditional cardiovascular risk factors compared to healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ankylosing spondylities patients | – | Device: carotid duplexdetect level of IL33 in serum of AS patients measure carotid intima media thickness by caroid dupex |
| control persons | – | Device: carotid duplexdetect level of IL33 in serum of normal control group measure carotid intima media thickness by caroid dupex |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * patient diagnosed as Ankylosing Spondylitis according to ASAS 2009 * Age (20-40)
Key inclusion criteria (2 listed)
- patient diagnosed as Ankylosing Spondylitis
- Age (20-40)
Key exclusion criteria (4 listed)
- Patients with other rheumatic diseases/other SPA types
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 |
|---|---|---|
| carotid duplexmeasure Carotid intima media thickness | Device | ankylosing spondylities patients, control persons |
Primary outcome
detect level of IL33 in AS patients
Time frame: 3 years
measure level of IL33 in the serum of AS patients measure caroid intima media thickness CIMT in AS patients
1 secondary outcome
detect the reation between IL33 and subclinical atherosclerosis in AS patients
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Results publication: PubMed 23409750Li GX, Wang S, Duan ZH, Zeng Z, Pan FM. Serum levels of IL-33 and its receptor ST2 are elevated in patients with ankylosing spondylitis. Scand J Rheumatol. 2013;42(3):226-31. doi: 10.3109/03009742.2012.735700. Epub 2013 Feb 15.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Assiut University.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya AbuAli, master (01097833248, ayaa.m.abuali471@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detect level of IL33 in AS patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564155, which also lists 1 linked publication.
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 22 Aug 2024.