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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04953871
Enrollment
31
Registered
2021-07-08
Start date
2017-01-31
Completion date
2018-01-31
Last updated
2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Tumor Necrosis Factor Drugs, Enthesitis, Spondyloarthritis

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.

Interventions

TNF inhibitors are widely used in patients with spondyloarthritis

Sponsors

Gunay ER
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Masking description

All patients were evaluated by the researcher who had a 10-year experience of musculoskeletal ultrasonography and is blind to clinical evaluation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change from ultrasonographic entesitis score at 3 monthsbefore and 3 months after anti-TNF treatmentMadrid Sonographic Enthesitis Index was used to screen etheseal sites

Secondary

MeasureTime frameDescription
Change from disease activitybefore and 3 months after anti-TNF treatmentBath Ankylosing Spondylitis Disease Activity Index was used
Change from quality of lifebefore and 3 months after anti-TNF treatmentAnkylosing Spondylitis Quality of Life was used
Change from Functionalitybefore and 3 months after anti-TNF treatmentBath Ankylosing Spondylitis Functionality Index was used

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026