Axial SpondyloarthritisNCT05914532
New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI
An observational study of Axial Spondyloarthritis, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA). 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
- What is being tested?
- lab testing
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2023to 10 Aug 2023
- Phase
- Observational
- 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
Study population: Group 1:healthy controls working in our hospital, Group 2: SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
Who may be able to join
- SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
- 51 healthy controls working in our hospital,
Who cannot join
- infections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Resarch Hospital
Istanbul
About this study
Official title: In Patients With Axial Spondyloarthropathy; Evaluation of the Relationship Between the Systemic Immune Inflammation Index and the Systemic Inflammatory Response Index With Disease Activity and Function
investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).
Read the detailed description
The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system. Then, the new biomarkers SIRI and SII values were calculated. SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count. Then, SIRI and SII values were compared between groups. The relationship between disease activity and SIRI and SII values in the patient group was examined.
- Conditions
- Axial Spondyloarthritis
- Being tested
- lab testing
- Keywords
- Axial Spondyloarthritis, Systemic Immune Inflammation Index, Systemic Inflammation Response Index
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lab testingOther
Complete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | healthy controls Receives: Other: lab testing | |
| group 2 | axial spondyloarthropathy Receives: Other: lab testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SIRI and SII between Patient and Healthy Control
SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count.
Measured: Baseline
Secondary outcomes (1)
Correlation analysis of SIRI and SII with scales and laboratory findings
SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start22 Jun 2023
- Primary completion10 Jul 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Tayyip Dede, Istanbul Training and Research Hospital
- Investigators
- Burak Tayyip DEDE, MD, Principal investigator, İstanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914532
- Sponsor's protocol ID
- 19/08/2022, 2011-KAEK-50: 262
- Status last verified
- Aug 2023
- First submitted
- 10 Jun 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21.
PubMed 34418163
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Patients With Axial Spondyloarthropathy; Evaluation of the Relationship Between the Systemic Immune Inflammation Index and the Systemic Inflammatory Response Index With Disease Activity and Function
- ClinicalTrials.gov ID
- NCT05914532
- Acronym / sponsor ID
- 19/08/2022, 2011-KAEK-50: 262
- Conditions
- Axial Spondyloarthritis
- Keywords
- Axial Spondyloarthritis, Systemic Immune Inflammation Index, Systemic Inflammation Response Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 22 Jun 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.
investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).
Detailed description
The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system. Then, the new biomarkers SIRI and SII values were calculated. SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count. Then, SIRI and SII values were compared between groups. The relationship between disease activity and SIRI and SII values in the patient group was examined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: lab testinghealthy controls |
| group 2 | – | Other: lab testingaxial spondyloarthropathy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1:healthy controls working in our hospital, Group 2: SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
Key inclusion criteria (2 listed)
- SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
- 51 healthy controls working in our hospital,
Key exclusion criteria (1 listed)
- infections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women
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 |
|---|---|---|
| lab testingComplete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test. | Other | group 1, group 2 |
Primary outcome
Comparison of SIRI and SII between Patient and Healthy Control
Time frame: Baseline
SIRI= neutrophil count*monocyte count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count.
1 secondary outcome
Correlation analysis of SIRI and SII with scales and laboratory findings
Time frame: Baseline
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 23 Aug 2023.
- Background: PubMed 34418163Wu J, Yan L, Chai K. Systemic immune-inflammation index is associated with disease activity in patients with ankylosing spondylitis. J Clin Lab Anal. 2021 Sep;35(9):e23964. doi: 10.1002/jcla.23964. Epub 2021 Aug 21.
- 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.
Burak Tayyip DEDE, MD principal investigator
İstanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis, run by Istanbul Training and Research Hospital 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 2 inclusion and 1 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 23 Aug 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. 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?
Comparison of SIRI and SII between Patient and Healthy Control (time frame: Baseline). 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 NCT05914532, which also lists 1 linked publication.
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 23 Aug 2023.