Clinical trial NCT06720376: Observational Prospective Turkish Inception Cohort of Uveitis and Spondyloarthritis
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spondylarthritis
Uveitis, Anterior
Keywords: Spondylarthritis, Acute Anterior Uveitis, Inflammatory Back Pain, HLA-B27
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Turkish population

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.


Eligibility criteria: Inclusion Criteria:

* patients with uveitis

Exclusion Criteria:

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

Primary outcomes:
measure: Assesing the Prevalance of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis.
timeFrame: 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.
measure: Assesing the Incidence of Axial- and Peripheral Spondyloarthritis according to ASAS Classification Criteria among Patients with Acute Anterior Uveitis after first diagnosis.
timeFrame: 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:
measure: Comparison of the HLA-B27 status among acute anterior uveitis patients with and without spondyloarthritis.
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
state: Maltepe
Study officials:
References: