Clinical trial NCT05771389: RAFTLIN-1 Levels in Axial Spondyloarthritis and Psoriatic Arthritis
Official title: Correlation of RAFTLIN-1 Levels and Clinical Parameters in Axial Spondyloarthritis and Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Axial Spondyloarthritis
Psoriatic Arthritis
Keywords: Axial Spondyloarthritis
Psoriatic Arthritis
Raftlin-1
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)
timeFrame: 1 day
measure: Bath Ankylosing Spondylitis Disease Activity Index(BASFI)
timeFrame: 1 day
measure: The Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 1 day
measure: Bath Ankylosing Spondylitis Metrology Index(BASMI)
timeFrame: 1 day
measure: Disease Activity Index for Psoriatic Arthritis (DAPSA)
timeFrame: 1 day
measure: Spondyloarthritis Research Consortium of Canada Enthesitis Index(SPARCC Enthesitis Index)
timeFrame: 1 day
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 1 day
measure: numeric rating scale (rest, movement)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
Study officials:
affiliation: Bezmialem University
name: Ozan Volkan Yurdakul, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem University
name: Mert Kara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem University
name: Ömer Faruk Özer, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudwaleit M, Haibel H, Baraliakos X, Listing J, Marker-Hermann E, Zeidler H, Braun J, Sieper J. The early disease stage in axial spondylarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Rheum. 2009 Mar;60(3):717-27. doi: 10.1002/art.24483.
citation: Saeki K, Miura Y, Aki D, Kurosaki T, Yoshimura A. The B cell-specific major raft protein, Raftlin, is necessary for the integrity of lipid raft and BCR signal transduction. EMBO J. 2003 Jun 16;22(12):3015-26. doi: 10.1093/emboj/cdg293.
citation: Saeki K, Fukuyama S, Ayada T, Nakaya M, Aki D, Takaesu G, Hanada T, Matsumura Y, Kobayashi T, Nakagawa R, Yoshimura A. A major lipid raft protein raftlin modulates T cell receptor signaling and enhances th17-mediated autoimmune responses. J Immunol. 2009 May 15;182(10):5929-37. doi: 10.4049/jimmunol.0802672.