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

Spondyloarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953871
• Other study ID #: 89403766-604.01.02-147611
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Enthesitis
• Enthesopathy
• Necrosis
• Spondylarthritis
• Spondyloarthritis

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