Back to resultsEnthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis
Primary Purpose
Spondyloarthritis, Enthesitis, Anti-Tumor Necrosis Factor Drugs
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TNF Inhibitor
Sponsored by
About this trial
This is an interventional screening trial for Spondyloarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spondyloarthritis
Arm Description
Spondyloarthritis patients who was initiated TNF alfa blocker
Outcomes
Primary Outcome Measures
change from ultrasonographic entesitis score at 3 months
Madrid Sonographic Enthesitis Index was used to screen etheseal sites
Secondary Outcome Measures
Change from disease activity
Bath Ankylosing Spondylitis Disease Activity Index was used
Change from disease activity
Ankylosing Spondylitis Disease Activity Score was used
Change from quality of life
Ankylosing Spondylitis Quality of Life was used
Change from Functionality
Bath Ankylosing Spondylitis Functionality Index was used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04953871
Brief Title
Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis
Official Title
Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gunay ER
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis, Enthesitis, Anti-Tumor Necrosis Factor Drugs
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All patients were evaluated by the researcher who had a 10-year experience of musculoskeletal ultrasonography and is blind to clinical evaluation.
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spondyloarthritis
Arm Type
Experimental
Arm Description
Spondyloarthritis patients who was initiated TNF alfa blocker
Intervention Type
Drug
Intervention Name(s)
TNF Inhibitor
Intervention Description
TNF inhibitors are widely used in patients with spondyloarthritis
Primary Outcome Measure Information:
Title
change from ultrasonographic entesitis score at 3 months
Description
Madrid Sonographic Enthesitis Index was used to screen etheseal sites
Time Frame
before and 3 months after anti-TNF treatment
Secondary Outcome Measure Information:
Title
Change from disease activity
Description
Bath Ankylosing Spondylitis Disease Activity Index was used
Time Frame
before and 3 months after anti-TNF treatment
Title
Change from disease activity
Description
Ankylosing Spondylitis Disease Activity Score was used
Time Frame
before and 3 months after anti-TNF treatment
Title
Change from quality of life
Description
Ankylosing Spondylitis Quality of Life was used
Time Frame
before and 3 months after anti-TNF treatment
Title
Change from Functionality
Description
Bath Ankylosing Spondylitis Functionality Index was used
Time Frame
before and 3 months after anti-TNF treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis
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