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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04953871
Other study ID # 89403766-604.01.02-147611
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2017
Est. completion date January 2018

Study information

Verified date July 2021
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date January 2018
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

Drug:
TNF Inhibitor
TNF inhibitors are widely used in patients with spondyloarthritis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gunay ER

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from disease activity Bath Ankylosing Spondylitis Disease Activity Index was used before and 3 months after anti-TNF treatment
Secondary Change from disease activity Ankylosing Spondylitis Disease Activity Score was used before and 3 months after anti-TNF treatment
Secondary Change from quality of life Ankylosing Spondylitis Quality of Life was used before and 3 months after anti-TNF treatment
Secondary Change from Functionality Bath Ankylosing Spondylitis Functionality Index was used before and 3 months after anti-TNF treatment
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