Autoimmune DiseasesNCT05915676
Role of LILRA3 in Ankylosing Spondylitis and Axial Psoriatic Patients
An observational study of Autoimmune Diseases, run by Assiut University.
Trial summary
1. To evaluate the frequency of LILRA3 in Ankylosing spondylitis and Axial psoriatic arthritis patients. 2. To investigate the association of LILRA3 with Ankylosing spondylitis and Axial psoriatic arthritis disease activity and severity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Leukocyte Immunoglobulin-like receptors A3
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Jul 2024
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Egyptian population
Who may be able to join
None listed.
Who cannot join
- 2-Individuals with other autoimmune diseases
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frequency Assessment of Leukocyte Immunoglobulin-like Receptors A3 In Ankylosing Spondylitis And Axial Psoriatic Arthritis Patients
- To evaluate the frequency of LILRA3 in Ankylosing spondylitis and Axial psoriatic arthritis patients.
- To investigate the association of LILRA3 with Ankylosing spondylitis and Axial psoriatic arthritis disease activity and severity.
Read the detailed description
Axial spondyloarthritis (axSpA) is a complex inflammatory condition that affects the axial skeleton including the sacroiliac joints and the spine (1). It also affects peripheral joints and can be associated with extra-musculoskeletal manifestations including uveitis, psoriasis, and inflammatory bowel disease (1).
Axial spondyloarthritis include ankylosing spondylitis (AS), certain forms of psoriatic arthritis (PsA), reactive arthritis with axial involvement, and arthritis associated with inflammatory bowel disease (2).
The diagnosis of axSpA remains very challenging with years of delays attributed to several different factors. There is also a strong need to identify new serological biomarkers that can aid clinicians for diagnosis of axSpA.
Leucocyte immunoglobulin-like receptor A3 (LILRA3) belongs to a family of leucocyte receptors produced as a soluble molecule by monocytes and macrophages. (3) The function of LILRA3 remains obscure, but LILRA3 could bind to HLA class I molecules HLA-G and HLA- C (4) and may act as an antagonist on other LILRs or a soluble ligand to other receptors(5) Growing evidence shows that (LILRA3) is associated with many autoimmune disorders.(6) (7) The functional LILRA3 is a susceptibility factor for AS and axial psoriatic arthritis (axPsA) has not been investigated.
- Conditions
- Autoimmune Diseases
- Being tested
- Leukocyte Immunoglobulin-like receptors A3
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte Immunoglobulin-like receptors A3Diagnostic test
Leucocyte immunoglobulin-like receptor A3 (LILRA3) belongs to a family of leucocyte receptors produced as a soluble molecule by monocytes and macrophages. (3) The function of LILRA3 remains obscure, but LILRA3 could bind to HLA class I molecules HLA-G and HLA- C (4) and may act as an antagonist on other LILRs or a soluble ligand to other receptors(5) Growing evidence shows that (LILRA3) is associated with many autoimmune disorders.(6) (7) The functional LILRA3 is a susceptibility factor for AS and axial psoriatic arthritis (axPsA) has not been investigated.
What is being measured
The primary outcome is the main question the study is designed to answer.
LILRA3 in AS and Axial psoriatic arthritis patients.
To evaluate the frequency of LILRA3 in Ankylosing spondylitis and Axial psoriatic arthritis patients.
Measured: Baseline
Secondary outcomes (1)
Assosciation of LILRA3 with disease severity
To investigate the association of LILRA3 with Ankylosing spondylitis and Axial psoriatic arthritis disease activity and severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Adel Abdelmoez, Assiut University
- Investigators
- Zahraa Abou eleyoun, PHD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915676
- Sponsor's protocol ID
- LILRA3 in AS, Axial psoriasis
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ryu M, Chen Y, Qi J, Liu J, Fan Z, Nam G, Shi Y, Cheng H, Gao GF. LILRA3 binds both classical and non-classical HLA class I molecules but with reduced affinities compared to LILRB1/LILRB2: structural evidence. PLoS One. 2011 Apr 29;6(4):e19245. doi: 10.1371/journal.pone.0019245.
PubMed 21559424Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.
PubMed 29227352Poddubnyy D. Axial spondyloarthritis: is there a treatment of choice? Ther Adv Musculoskelet Dis. 2013 Feb;5(1):45-54. doi: 10.1177/1759720X12468658.
PubMed 23514983Norman PJ, Carey BS, Stephens HAF, Vaughan RW. DNA sequence variation and molecular genotyping of natural killer leukocyte immunoglobulin-like receptor, LILRA3. Immunogenetics. 2003 Jun;55(3):165-171. doi: 10.1007/s00251-003-0561-1. Epub 2003 May 16.
PubMed 12750859
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency Assessment of Leukocyte Immunoglobulin-like Receptors A3 In Ankylosing Spondylitis And Axial Psoriatic Arthritis Patients
- ClinicalTrials.gov ID
- NCT05915676
- Acronym / sponsor ID
- LILRA3 in AS, Axial psoriasis
- Conditions
- Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 23 Jun 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.
- To evaluate the frequency of LILRA3 in Ankylosing spondylitis and Axial psoriatic arthritis patients.
- To investigate the association of LILRA3 with Ankylosing spondylitis and Axial psoriatic arthritis disease activity and severity.
Detailed description
Axial spondyloarthritis (axSpA) is a complex inflammatory condition that affects the axial skeleton including the sacroiliac joints and the spine (1). It also affects peripheral joints and can be associated with extra-musculoskeletal manifestations including uveitis, psoriasis, and inflammatory bowel disease (1).
Axial spondyloarthritis include ankylosing spondylitis (AS), certain forms of psoriatic arthritis (PsA), reactive arthritis with axial involvement, and arthritis associated with inflammatory bowel disease (2).
The diagnosis of axSpA remains very challenging with years of delays attributed to several different factors. There is also a strong need to identify new serological biomarkers that can aid clinicians for diagnosis of axSpA.
Leucocyte immunoglobulin-like receptor A3 (LILRA3) belongs to a family of leucocyte receptors produced as a soluble molecule by monocytes and macrophages. (3) The function of LILRA3 remains obscure, but LILRA3 could bind to HLA class I molecules HLA-G and HLA- C (4) and may act as an antagonist on other LILRs or a soluble ligand to other receptors(5) Growing evidence shows that (LILRA3) is associated with many autoimmune disorders.(6) (7) The functional LILRA3 is a susceptibility factor for AS and axial psoriatic arthritis (axPsA) has not been investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Egyptian population
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 2-Individuals with other autoimmune diseases
- -
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 |
|---|---|---|
| Leukocyte Immunoglobulin-like receptors A3Leucocyte immunoglobulin-like receptor A3 (LILRA3) belongs to a family of leucocyte receptors produced as a soluble molecule by monocytes and macrophages. (3) The function of LILRA3 remains obscure, but LILRA3 could bind to HLA class I molecules HLA-G and HLA- C (4) and may act as an antagonist on other LILRs or a soluble ligand to other receptors(5) Growing evidence shows that (LILRA3) is associated with many autoimmune disorders.(6) (7) The functional LILRA3 is a susceptibility factor for AS and axial psoriatic arthritis (axPsA) has not been investigated. | Diagnostic test | – |
Primary outcome
LILRA3 in AS and Axial psoriatic arthritis patients.
Time frame: Baseline
To evaluate the frequency of LILRA3 in Ankylosing spondylitis and Axial psoriatic arthritis patients.
1 secondary outcome
Assosciation of LILRA3 with disease severity
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 21559424Ryu M, Chen Y, Qi J, Liu J, Fan Z, Nam G, Shi Y, Cheng H, Gao GF. LILRA3 binds both classical and non-classical HLA class I molecules but with reduced affinities compared to LILRB1/LILRB2: structural evidence. PLoS One. 2011 Apr 29;6(4):e19245. doi: 10.1371/journal.pone.0019245.
- Results publication: PubMed 29227352Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.
- Results publication: PubMed 23514983Poddubnyy D. Axial spondyloarthritis: is there a treatment of choice? Ther Adv Musculoskelet Dis. 2013 Feb;5(1):45-54. doi: 10.1177/1759720X12468658.
- Results publication: PubMed 12750859Norman PJ, Carey BS, Stephens HAF, Vaughan RW. DNA sequence variation and molecular genotyping of natural killer leukocyte immunoglobulin-like receptor, LILRA3. Immunogenetics. 2003 Jun;55(3):165-171. doi: 10.1007/s00251-003-0561-1. Epub 2003 May 16.
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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.
Zahraa Abou eleyoun, PHD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases, 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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Adel (+201124098363, alaa.adel27@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LILRA3 in AS and Axial psoriatic arthritis patients. (time frame: Baseline). 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 NCT05915676, which also lists 4 linked publications.
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 23 Jun 2023.