RAFTLIN-1 Levels in Axial Spondyloarthritis and Psoriatic Arthritis

Bezmialem Vakif University

Status: Completed

Conditions: Psoriatic Arthritis; Axial Spondyloarthritis

Treatments: Diagnostic Test: serum raftlin-1 protein levels

Study type: Interventional

Funder types: Other

Identifiers

NCT05771389

17.11.2021-E.40188

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 3 patient groups, including a placebo group

Psoriatic arthritis

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: serum raftlin-1 protein levels

Axial spondyloarthritis

Active Comparator group

Description:

Patients meeting the ASAS classification criteria for axial spondyloarthritis

Treatment:

Diagnostic Test: serum raftlin-1 protein levels

Healthy controls

Placebo Comparator group

Description:

Healthy people who do not have inflammatory conditions.

Treatment:

Diagnostic Test: serum raftlin-1 protein levels