Clinical trial NCT05915676: Role of LILRA3 in Ankylosing Spondylitis and Axial Psoriatic Patients
Official title: Frequency Assessment of Leukocyte Immunoglobulin-like Receptors A3 In Ankylosing Spondylitis And Axial Psoriatic Arthritis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian population

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:Adult AS and axPsA patients \<18 years Who fulfilled the Assessment of SpondyloArthritis international Society (ASAS) criteria for axSpA.

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Exclusion Criteria:1-patients less than 18 years old

2-Individuals with other autoimmune diseases

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Primary outcomes:
measure: LILRA3 in AS and Axial psoriatic arthritis patients.
timeFrame: Baseline
Secondary outcomes:
measure: Assosciation of LILRA3 with disease severity
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Zahraa Abou eleyoun, PHD
role: STUDY_CHAIR
References:
citation: 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.
citation: Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.
citation: Poddubnyy D. Axial spondyloarthritis: is there a treatment of choice? Ther Adv Musculoskelet Dis. 2013 Feb;5(1):45-54. doi: 10.1177/1759720X12468658.
citation: Norman 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.