RAFTLIN-1 Levels in Axial Spondyloarthritis and Psoriatic Arthritis

NCT05771389 | Completed

• 1 other identifier: 17.11.2021-E.40188
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Axial Spondyloarthritis; Psoriatic Arthritis

Keywords

Axial Spondyloarthritis; Psoriatic Arthritis; Raftlin-1

Outcome Measures

Primary Outcomes (8)

• Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)

  This questionnaire evaluates the disease activity level in patients with AS. The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS. The final score varies between 0 and 10.

  1 day

• Bath Ankylosing Spondylitis Disease Activity Index(BASFI)

  This questionnaire evaluates the functionality in patients with AS. The ten questions that comprise the BASFI were chosen with input from patients with AS. The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease. The final 2 questions evaluate the patients' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible) is used to answer the questions on the test. The final score varies between 0 and 10.

  1 day

• The Ankylosing Spondylitis Disease Activity Score (ASDAS)

  AS Disease Activity Score has been developed by taking into account total back pain (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 2), patient global evaluation, peripheral joint pain or swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6), and C-reactive protein (CRP) (or erythrocyte sedimentation rate \[ESR\] if CRP is not available). The cutoffs between the disease activity states are inactive disease ≤1.3, moderate 1.3-2.0, high 2.1-3.5, and very high ≥3.5. The ASDAS cutoff for clinically important improvement between examinations is ≥1.1, and the cutoff for a major improvement is ≥2.0.

  1 day

• Bath Ankylosing Spondylitis Metrology Index(BASMI)

  Bath Ankylosing Spondylitis Metrology Index, a combined index to assess the spinal mobility. It evaluates the patients regarding cervical rotation, tragus-to-wall distance, lumbar flexion, lumbar lateral flexion and intermalleolar distance. The total score varies between 5 to 15 in patients with ankylosing spondylitis

  1 day

• Disease Activity Index for Psoriatic Arthritis (DAPSA)

  DAPSA includes a 68/66 joint count summed with a patient global, patient pain score, and C- reactive protein level. The DAPSA provides a continuous score of arthritis activity and has validated cut points for remission (\< 4) and low disease activity (\< 14).

  1 day

• Spondyloarthritis Research Consortium of Canada Enthesitis Index(SPARCC Enthesitis Index)

  The Spondyloarthritis Research Consortium of Canada (SPARCC) index, developed in Canada by Walter Maksymowych and others, was developed in patients with spondyloarthritis and includes assessment of 18 sites for tenderness. The total score is 16, because the distal patella and tibial tuberosity, in close proximity, are considered as one site. The core is between 0 and 16.

  1 day

• Health Assessment Questionnaire (HAQ)

  The Health assessment questionnaire (HAQ) is a questionnaire for the assessment of disability in an individual. The patients report the amount of difficulty they have in performing eight daily living activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The final score varies between 0 and 3.

  1 day

• numeric rating scale (rest, movement)

  Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.

  1 day

Study Arms (3)

Psoriatic arthritis

ACTIVE COMPARATOR

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

Diagnostic Test: serum raftlin-1 protein levels

Axial spondyloarthritis

ACTIVE COMPARATOR

Patients meeting the ASAS classification criteria for axial spondyloarthritis

Diagnostic Test: serum raftlin-1 protein levels

Healthy controls

PLACEBO COMPARATOR

Healthy people who do not have inflammatory conditions.

Diagnostic Test: serum raftlin-1 protein levels

Interventions

serum raftlin-1 protein levels 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; Healthy controls; Psoriatic arthritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 19248087 BACKGROUND

• 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.

  PMID: 12805216 BACKGROUND

• 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.

  PMID: 19414744 BACKGROUND

• Yurdakul OV, Kara M, Ince B, Yildiz C, Yildiz T, Kilicoglu MS, Aydin T, Ozer OF. Raftlin - a potential biomarker for axial spondyloarthritis and psoriatic arthritis: An observational study. Medicine (Baltimore). 2024 Jun 28;103(26):e38770. doi: 10.1097/MD.0000000000038770.

  PMID: 38941376 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ozan Volkan Yurdakul, Assoc. Prof.

  Bezmialem University

  PRINCIPAL INVESTIGATOR

• Mert Kara, MD

  Bezmialem University

  PRINCIPAL INVESTIGATOR

• Ömer Faruk Özer, Assoc. Prof.

  Bezmialem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: March 21, 2023
• Primary Completion: July 9, 2023
• Study Completion: July 9, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)