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NCT Number: NCT04953871

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

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Key information

Conditions

Spondyloarthritis Anti-Tumor Necrosis Factor Drugs Arthritis Bone Diseases Enthesitis Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNF Inhibitor

Drug

TNF inhibitors are widely used in patients with spondyloarthritis

Primary outcomes

  1. change from ultrasonographic entesitis score at 3 months

    Time frame: before and 3 months after anti-TNF treatment

    Madrid Sonographic Enthesitis Index was used to screen etheseal sites

Secondary outcomes

  1. Change from disease activity

    Time frame: before and 3 months after anti-TNF treatment

    Bath Ankylosing Spondylitis Disease Activity Index was used

  2. Change from disease activity

    Time frame: before and 3 months after anti-TNF treatment

    Ankylosing Spondylitis Disease Activity Score was used

  3. Change from quality of life

    Time frame: before and 3 months after anti-TNF treatment

    Ankylosing Spondylitis Quality of Life was used

  4. Change from Functionality

    Time frame: before and 3 months after anti-TNF treatment

    Bath Ankylosing Spondylitis Functionality Index was used

Sponsors and collaborators

Lead sponsor

Gunay ER

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 8, 2021
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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