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

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

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.

Study Overview

• Status: Completed
• Conditions: Spondyloarthritis; Enthesitis; Anti-Tumor Necrosis Factor Drugs
• Intervention / Treatment: Drug: TNF Inhibitor

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spondyloarthritis; Spondyloarthritis patients who was initiated TNF alfa blocker	Drug: TNF Inhibitor; TNF inhibitors are widely used in patients with spondyloarthritis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gunay ER

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthritis; Muscular Diseases; Tendon Injuries; Spinal Diseases; Bone Diseases; Tendinopathy; Bone Diseases, Infectious; Necrosis; Enthesopathy; Spondylitis; Spondylarthritis; Anti-Inflammatory Agents; Tumor Necrosis Factor Inhibitors
• Other Study ID Numbers: 89403766-604.01.02-147611

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes