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RecruitingNCT06720376OPTICUSUpdated Dec 6, 2024

Observational Prospective Turkish Inception Cohort of Uveitis and Spondyloarthritis

An observational study in Spondylarthritis and Uveitis, Anterior, sponsored by Marmara University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by Marmara University · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Spondylarthritis
  • Uveitis, Anterior

Keywords

  • Spondylarthritis, Acute Anterior Uveitis, Inflammatory Back Pain, HLA-B27
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In context

Spondylarthritis

202 studies on the registry are indexed under Spondylarthritis; 51 are open to participants now.

This study's planned enrollment of 100 is below the median of 240 across 93 observational studies indexed under Spondylarthritis.

Browse Spondylarthritis studies →

Lead sponsor

Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Turkish population

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with uveitis

Exclusion criteria

Exclusion Criteria:

  • patients diagnosed spondyloarthiritis before from the uveitis attack
  • patients with infectious uveitis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • main cohort
06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

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.

    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.

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06720376
Lead sponsor
Marmara University
Responsible party
Mehmet Pamir Atagunduz (Professor, Marmara University) — Principal investigator
First posted
Dec 6, 2024
Start date
Jan 15, 2023
Primary completion
Jan 15, 2028 (estimated)
Completion
Jan 15, 2030 (estimated)
Last update
Dec 6, 2024

Study contacts

Mehmet P ATAGUNDUZ, MD
Contact
pamiratagunduz@marmara.edu.tr
+90(530) 939 45 94
Şeyma ÇOLAKOĞLU-ÖZKAYA, PhD
Contact
seymacolakoglu5@gmail.com
+90(536) 519 88 60

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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