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

Phase 4

Completed

• Conditions: Enthesitis; Spondyloarthritis; Anti-Tumor Necrosis Factor Drugs
• Interventions: Drug: TNF Inhibitor

• Registration Number: NCT04953871
• Lead Sponsor: Gunay ER

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-09
• Study Completion: 2018-01
• Study First Submitted: 2021-06-22
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spondyloarthritis	TNF Inhibitor	Spondyloarthritis patients who was initiated TNF alfa blocker

Primary Outcome Measures

Name	Time	Method
change from ultrasonographic entesitis score at 3 months	before and 3 months after anti-TNF treatment	Madrid Sonographic Enthesitis Index was used to screen etheseal sites

Secondary Outcome Measures

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