RAFTLIN-1 Levels in Axial Spondyloarthritis and Psoriatic Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2023-07-09

Brief Summary

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Unlike other rheumatic diseases, acute phase reactants such as C-reactive protein and erythrocyte sedimentation rate are not diagnostic for patients with Spondyloarthropathies (SpA). Also, it is not possible to monitor disease activity with these tests. On the other hand, HLA-B27 positivity varies between races, and 8% of the normal population is HLA-B27 positive. In this manner, new biomarkers for endorsing the diagnosis and monitoring the disease activity are necessary.

Acute phase reactants are not sensitive for diagnosing and assessing disease activity. This may lead to a diagnostic delay of up to 9 years. The investigators hypothesize that Raftlin-1, thought to have a regulatory role in TH17 function and IL-17-mediated immunity, may be a novel biomarker for showing inflammation-related clinical features.

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Detailed Description

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Unlike other rheumatic diseases, acute phase reactants such as C-reactive protein and erythrocyte sedimentation rate are not diagnostic for patients with Spondyloarthropathies (SpA). Also, it is not possible to monitor disease activity with these tests. On the other hand, HLA-B27 positivity varies between races, and 8% of the normal population is HLA-B27 positive. In this manner, new biomarkers for endorsing the diagnosis and monitoring the disease activity are necessary.

In recent years Raftlin, a significant lipid raft protein responsible for transmembrane signal transmission, was found. It has been discovered that the Raftlin protein has two subtypes (Raftlin-1 and Raftlin-2), and in transgenic mice without RAFTLIN genes, T-cell-dependent immunity has been altered.

Cytokine production, especially IL-17, is diminished in T cells with the lack of Raftlin protein, while it is increased in T cells, including transgenic Raftlin. This condition is associated with TCR-related signaling pathways. Particularly, Lck protein occurrence in lipid raft is increased with Raftlin overexpression, while it is diminished with absence. Regarding this, Raftlin is thought to modulate TCR signaling, thus altering the T-cell mediated immunity.

Acute phase reactants are not sensitive for diagnosing and assessing disease activity. This may lead to a diagnostic delay of up to 9 years. The investigators hypothesize that Raftlin-1, thought to have a regulatory role in TH17 function and IL-17-mediated immunity, may be a novel biomarker for showing inflammation-related clinical features.

Conditions

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Axial Spondyloarthritis Psoriatic Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Psoriatic arthritis

Patients meeting the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria

Group Type ACTIVE_COMPARATOR

serum raftlin-1 protein levels

Intervention Type DIAGNOSTIC_TEST

Lipid raft linker 1 (Raftlin-1) is a protein which enables double-stranded RNA binding activity. It is involved in T cell receptor signaling pathway; membrane raft assembly; and positive regulation of growth rate. It acts upstream of or within dsRNA transport; response to exogenous dsRNA; and toll-like receptor signaling pathway. Located in endosome; membrane raft; and plasma membrane.

Axial spondyloarthritis

Patients meeting the ASAS classification criteria for axial spondyloarthritis

Group Type ACTIVE_COMPARATOR

serum raftlin-1 protein levels

Intervention Type DIAGNOSTIC_TEST

Lipid raft linker 1 (Raftlin-1) is a protein which enables double-stranded RNA binding activity. It is involved in T cell receptor signaling pathway; membrane raft assembly; and positive regulation of growth rate. It acts upstream of or within dsRNA transport; response to exogenous dsRNA; and toll-like receptor signaling pathway. Located in endosome; membrane raft; and plasma membrane.

Healthy controls

Healthy people who do not have inflammatory conditions.

Group Type PLACEBO_COMPARATOR

serum raftlin-1 protein levels

Intervention Type DIAGNOSTIC_TEST

Lipid raft linker 1 (Raftlin-1) is a protein which enables double-stranded RNA binding activity. It is involved in T cell receptor signaling pathway; membrane raft assembly; and positive regulation of growth rate. It acts upstream of or within dsRNA transport; response to exogenous dsRNA; and toll-like receptor signaling pathway. Located in endosome; membrane raft; and plasma membrane.

Interventions

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serum raftlin-1 protein levels

Lipid raft linker 1 (Raftlin-1) is a protein which enables double-stranded RNA binding activity. It is involved in T cell receptor signaling pathway; membrane raft assembly; and positive regulation of growth rate. It acts upstream of or within dsRNA transport; response to exogenous dsRNA; and toll-like receptor signaling pathway. Located in endosome; membrane raft; and plasma membrane.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Being aged 18 to 65
* Meeting ASAS axial spondyloarthritis classification criteria
* Meeting The CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria

Exclusion Criteria

* Having a burn or a wound
* Active infection
* systemic inflammatory disease (Type 1 DM, autoimmune thyroiditis, other inflammatory rheumatic conditions etc.)
* Pregnancy
* Malignancy
* severe cognitive function disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes