Axial SpondyloarthritisNCT05771389
RAFTLIN-1 Levels in Axial Spondyloarthritis and Psoriatic Arthritis
A study testing serum raftlin-1 protein levels in people with Axial Spondyloarthritis and Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis, Psoriatic Arthritis
- What is being tested?
- serum raftlin-1 protein levels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2023to 9 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being aged 18 to 65
- Meeting ASAS axial spondyloarthritis classification criteria
- Meeting The CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of RAFTLIN-1 Levels and Clinical Parameters in Axial Spondyloarthritis and Psoriatic Arthritis
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.
Read the 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.
- Conditions
- Axial Spondyloarthritis, Psoriatic Arthritis
- Being tested
- serum raftlin-1 protein levels
- Keywords
- Axial Spondyloarthritis, Psoriatic Arthritis, Raftlin-1
- Medical subject headings
- Axial Spondyloarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum raftlin-1 protein levelsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis | Active comparator | Patients meeting the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria Receives: Diagnostic Test: serum raftlin-1 protein levels |
| Axial spondyloarthritis | Active comparator | Patients meeting the ASAS classification criteria for axial spondyloarthritis Receives: Diagnostic Test: serum raftlin-1 protein levels |
| Healthy controls | Placebo comparator | Healthy people who do not have inflammatory conditions. Receives: Diagnostic Test: serum raftlin-1 protein levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1 day
numeric rating scale (rest, movement)
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start21 Mar 2023
- Primary completion9 Jul 2023
- Study completion9 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozan Volkan Yurdakul, Assoc. Prof., Principal investigator, Bezmialem UniversityMert Kara, MD, Principal investigator, Bezmialem UniversityÖmer Faruk Özer, Assoc. Prof., Principal investigator, Bezmialem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771389
- Sponsor's protocol ID
- 17.11.2021-E.40188
- Status last verified
- Jul 2023
- First submitted
- 5 Mar 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19248087Saeki 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.
PubMed 12805216Saeki 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.
PubMed 19414744Yurdakul 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.
PubMed 38941376
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of RAFTLIN-1 Levels and Clinical Parameters in Axial Spondyloarthritis and Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT05771389
- Acronym / sponsor ID
- 17.11.2021-E.40188
- Conditions
- Axial Spondyloarthritis, Psoriatic Arthritis
- Keywords
- Axial Spondyloarthritis, Psoriatic Arthritis, Raftlin-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 9 Jul 2023 (actual)
- Study completion
- 9 Jul 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis | Active comparator | Diagnostic Test: serum raftlin-1 protein levelsPatients meeting the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria |
| Axial spondyloarthritis | Active comparator | Diagnostic Test: serum raftlin-1 protein levelsPatients meeting the ASAS classification criteria for axial spondyloarthritis |
| Healthy controls | Placebo comparator | Diagnostic Test: serum raftlin-1 protein levelsHealthy people who do not have inflammatory conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being aged 18 to 65
- Meeting ASAS axial spondyloarthritis classification criteria
- Meeting The CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria
Key exclusion criteria (6 listed)
- Having a burn or a wound
- Active infection
- systemic inflammatory disease (Type 1 DM, autoimmune thyroiditis, other inflammatory rheumatic conditions etc.)
- Pregnancy
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum raftlin-1 protein levelsLipid 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. | Diagnostic test | Axial spondyloarthritis, Healthy controls, Psoriatic arthritis |
Primary outcome
Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)
Time frame: 1 day
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.
Bath Ankylosing Spondylitis Disease Activity Index(BASFI)
Time frame: 1 day
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.
The Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 1 day
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.
Bath Ankylosing Spondylitis Metrology Index(BASMI)
Time frame: 1 day
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
Disease Activity Index for Psoriatic Arthritis (DAPSA)
Time frame: 1 day
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).
Spondyloarthritis Research Consortium of Canada Enthesitis Index(SPARCC Enthesitis Index)
Time frame: 1 day
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.
Health Assessment Questionnaire (HAQ)
Time frame: 1 day
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.
numeric rating scale (rest, movement)
Time frame: 1 day
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 19248087Rudwaleit 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.
- Background: PubMed 12805216Saeki 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.
- Background: PubMed 19414744Saeki 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.
- Derived from this study: PubMed 38941376Yurdakul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozan Volkan Yurdakul, Assoc. Prof. principal investigator
Bezmialem University
Mert Kara, MD principal investigator
Bezmialem University
Ömer Faruk Özer, Assoc. Prof. principal investigator
Bezmialem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum raftlin-1 protein levels in people with Axial Spondyloarthritis and Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bath Ankylosing Spondylitis Disease Activity Index(BASDAI) (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05771389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.