Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis

Study Overview
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Brief Summary
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Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.

Official Title
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Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis

Conditions
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Spondyloarthritis, Enthesitis, Anti-Tumor Necrosis Factor Drugs

Intervention / Treatment
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* Drug: TNF Inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spondyloarthritis patients were diagnosed according to 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria Exclusion Criteria: Severe cardiovascular and respiratory diseases, Severe liver and kidney failure, Pregnancy and lactation, Active infection, Malignancy, Demyelinating diseases, Systemic lupus erythematosus, History of knee, elbow, foot and ankle surgery, Fluoroquinolone, retinoid and fluoride use, Local corticosteroid injection at the examination sites within the six weeks before evaluation Peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spondyloarthritis<br>Spondyloarthritis patients who was initiated TNF alfa blocker | Drug: TNF Inhibitor<br>* TNF inhibitors are widely used in patients with spondyloarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from ultrasonographic entesitis score at 3 months | Madrid Sonographic Enthesitis Index was used to screen etheseal sites | before and 3 months after anti-TNF treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from disease activity | Bath Ankylosing Spondylitis Disease Activity Index was used | before and 3 months after anti-TNF treatment | 
| Change from disease activity | Ankylosing Spondylitis Disease Activity Score was used | before and 3 months after anti-TNF treatment | 
| Change from quality of life | Ankylosing Spondylitis Quality of Life was used | before and 3 months after anti-TNF treatment | 
| Change from Functionality | Bath Ankylosing Spondylitis Functionality Index was used | before and 3 months after anti-TNF treatment |