Observational Prospective Turkish Inception Cohort of Uveitis and Spondyloarthritis

NCT06720376 | Recruiting DMC

• 1 other identifier: OPTICUS.001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spondylarthritis; Uveitis, Anterior

Keywords

Spondylarthritis, Acute Anterior Uveitis, Inflammatory Back Pain, HLA-B27

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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.

Study Arms (1)

main cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Turkish population

You may qualify if:

• patients with uveitis

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Maltepe, 34854, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

As the first stage, blood samples will be collected in EDTA tubes, subsequently will be isolated with commercial kits. DNA samples will be stored at -80 fridge.

MeSH Terms

Conditions

Spondylarthritis; Uveitis, Anterior

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Central Study Contacts

Mehmet P ATAGUNDUZ, MD

CONTACT

+90(530) 939 45 94; pamiratagunduz@marmara.edu.tr

Şeyma ÇOLAKOĞLU-ÖZKAYA, PhD

CONTACT

+90(536) 519 88 60; seymacolakoglu5@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 15, 2023
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2030
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)