SpondylarthritisOPTICUSNCT06720376
Observational Prospective Turkish Inception Cohort of Uveitis and Spondyloarthritis
An observational study of Spondylarthritis and Uveitis, Anterior, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Spondyloarthritis (SpA) encompasses a group of inflammatory rheumatic diseases characterized by axial and/or peripheral arthritis, along with extra-articular manifestations such as enthesitis, dactylitis, uveitis, and skin lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spondylarthritis, Uveitis, Anterior
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Turkish population
Who may be able to join
- patients with uveitis
Who cannot join
- patients diagnosed spondyloarthiritis before from the uveitis attack
- patients with infectious uveitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine
Istanbul, Maltepe, 34854
Mehmet P ATAGUNDUZ, MD, +90(530) 939 45 94, pamiratagunduz@marmara.edu.tr
Şeyma ÇOLAKOĞLU-ÖZKAYA, PhD, +90(536) 519 88 60, seymacolakoglu5@gmail.com
About this study
Official title: Assessment of Spondyloarthritis in an Acute Anterior Uveitis Inception Cohort: a Cross Sectional and Prospective Comparative Study of HLA-B27-positive and -negative Cases
Spondyloarthritis (SpA) encompasses a group of inflammatory rheumatic diseases characterized by axial and/or peripheral arthritis, along with extra-articular manifestations such as enthesitis, dactylitis, uveitis, and skin lesions. Axial spondyloarthritis (axSpA), the hallmark of which is chronic sacroiliitis, can progress to vertebral fusion ("bamboo spine") in advanced cases. The prevalence of axSpA varies globally, ranging from 0.1% to 1.4%, with a higher incidence in men and a typical onset in the second or third decades of life. Diagnostic approaches include imaging techniques such as sacroiliac MRI and radiographs, alongside clinical criteria like inflammatory back pain, NSAID responsiveness, peripheral arthritis, and HLA-B27 positivity. Disease management primarily involves NSAIDs, with biologics used for refractory cases, and disease activity is monitored using indices such as BASDAI and ASDAS.
Acute anterior uveitis (AAU) is the most common extra-articular manifestation of SpA, particularly associated with HLA-B27 positivity. It often presents unilaterally with redness, pain, and photophobia but can lead to severe complications if inadequately treated. Around 50% of patients with HLA-B27-positive AAU have underlying SpA, and the prevalence of uveitis increases with longer disease duration. While the link between SpA and AAU is well-established, further research is needed to determine optimal systemic treatment and follow-up protocols. This study aims to assess the prevalence and clinical characteristics of SpA in patients presenting with AAU at ophthalmology clinics.
- Conditions
- Spondylarthritis, Uveitis, Anterior
- Keywords
- Spondylarthritis, Acute Anterior Uveitis, Inflammatory Back Pain, HLA-B27
- Medical subject headings
- Spondylarthritis, Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| main cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesing the Prevalance of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis.
Presence of undiagnosed or known Spondyloarthritis will be assessed in a cross-sectional manner at time of acute anterior uveitis.
Measured: Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
Assesing the Incidence of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis after first diagnosis.
Development of an full-blown Spondyloarthritis will be assessed long-term in a prospective manner.
Measured: Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the fifth year after the inclusion of the last patient with acute anterior uveits.
Secondary outcomes (1)
Comparison of the HLA-B27 status among acute anterior uveitis patients with and without spondyloarthritis.
HLA-B27 status will be assessed in patints with idiopathic acute- and spondyloarthritis associated anterior uveitis will be assessed.
Measured: Cross-sectional anaylsis of the first two hundered patients for the prevalance of HLA-B27 is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Jan 2023
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Pamir Atagunduz, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720376
- Sponsor's protocol ID
- OPTICUS.001
- Acronym
- OPTICUS
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Spondyloarthritis in an Acute Anterior Uveitis Inception Cohort: a Cross Sectional and Prospective Comparative Study of HLA-B27-positive and -negative Cases
- ClinicalTrials.gov ID
- NCT06720376
- Acronym / sponsor ID
- OPTICUS / OPTICUS.001
- Conditions
- Spondylarthritis, Uveitis, Anterior
- Keywords
- Spondylarthritis, Acute Anterior Uveitis, Inflammatory Back Pain, HLA-B27
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 6 Dec 2024 (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.
Spondyloarthritis (SpA) encompasses a group of inflammatory rheumatic diseases characterized by axial and/or peripheral arthritis, along with extra-articular manifestations such as enthesitis, dactylitis, uveitis, and skin lesions. Axial spondyloarthritis (axSpA), the hallmark of which is chronic sacroiliitis, can progress to vertebral fusion ("bamboo spine") in advanced cases. The prevalence of axSpA varies globally, ranging from 0.1% to 1.4%, with a higher incidence in men and a typical onset in the second or third decades of life. Diagnostic approaches include imaging techniques such as sacroiliac MRI and radiographs, alongside clinical criteria like inflammatory back pain, NSAID responsiveness, peripheral arthritis, and HLA-B27 positivity. Disease management primarily involves NSAIDs, with biologics used for refractory cases, and disease activity is monitored using indices such as BASDAI and ASDAS.
Acute anterior uveitis (AAU) is the most common extra-articular manifestation of SpA, particularly associated with HLA-B27 positivity. It often presents unilaterally with redness, pain, and photophobia but can lead to severe complications if inadequately treated. Around 50% of patients with HLA-B27-positive AAU have underlying SpA, and the prevalence of uveitis increases with longer disease duration. While the link between SpA and AAU is well-established, further research is needed to determine optimal systemic treatment and follow-up protocols. This study aims to assess the prevalence and clinical characteristics of SpA in patients presenting with AAU at ophthalmology clinics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main cohort | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish population
Key inclusion criteria (1 listed)
- patients with uveitis
Key exclusion criteria (2 listed)
- patients diagnosed spondyloarthiritis before from the uveitis attack
- patients with infectious uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assesing the Prevalance of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis.
Time frame: Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
Presence of undiagnosed or known Spondyloarthritis will be assessed in a cross-sectional manner at time of acute anterior uveitis.
Assesing the Incidence of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis after first diagnosis.
Time frame: Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the fifth year after the inclusion of the last patient with acute anterior uveits.
Development of an full-blown Spondyloarthritis will be assessed long-term in a prospective manner.
1 secondary outcome
Comparison of the HLA-B27 status among acute anterior uveitis patients with and without spondyloarthritis.
Time frame: Cross-sectional anaylsis of the first two hundered patients for the prevalance of HLA-B27 is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
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 Spondylarthritis and Uveitis, Anterior, run by Marmara 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet P ATAGUNDUZ, MD (+90(530) 939 45 94, pamiratagunduz@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesing the Prevalance of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis. (time frame: Cross-sectional anaylsis of the first two hundered patients for the prevalance of Spondyloarthritis is anticipated to be analyzed at the end of the second year after the inclusion of the first patient with acute anterior uveits.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2024.