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

NCT04953871 | Completed Phase 4 FDA Drug

• 1 other identifier: 89403766-604.01.02-147611
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spondyloarthritis; Enthesitis; Anti-Tumor Necrosis Factor Drugs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from disease activity

  before and 3 months after anti-TNF treatment

• Change from disease activity

  before and 3 months after anti-TNF treatment

• Change from quality of life

  before and 3 months after anti-TNF treatment

• Change from Functionality

  before and 3 months after anti-TNF treatment

Study Arms (1)

Spondyloarthritis

EXPERIMENTAL

Spondyloarthritis patients who was initiated TNF alfa blocker

Drug: TNF Inhibitor

Interventions

TNF Inhibitor DRUG

TNF inhibitors are widely used in patients with spondyloarthritis

Spondyloarthritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spondyloarthritis patients were diagnosed according to 2009 Assessment of Spondyloarthritis International Society (ASAS) criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Gunay ER: lead

MeSH Terms

Conditions

Spondylarthritis

Interventions

Tumor Necrosis Factor Inhibitors

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Anti-Inflammatory Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: All patients were evaluated by the researcher who had a 10-year experience of musculoskeletal ultrasonography and is blind to clinical evaluation.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 8, 2021
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 8, 2021

Record last verified: 2021-07