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

NCT ID: NCT04953871

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spondyloarthritis Enthesitis Anti-Tumor Necrosis Factor Drugs

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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

Study Groups

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Spondyloarthritis

Spondyloarthritis patients who was initiated TNF alfa blocker

Group Type EXPERIMENTAL

TNF Inhibitor

Intervention Type DRUG

TNF inhibitors are widely used in patients with spondyloarthritis

Interventions

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TNF Inhibitor

TNF inhibitors are widely used in patients with spondyloarthritis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gunay ER

OTHER

Sponsor Role lead

Responsible Party

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Gunay ER

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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89403766-604.01.02-147611

Identifier Type: -

Identifier Source: org_study_id

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