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Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy

NCT01219257 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-08-02

No results posted yet for this study

Summary

Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it is necessary to have a sensitive method for assessing the response to treatment. Ultrasonography (US) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response.

The present study will include patients with SpA starting on anti-TNF alpha treatment (as first biologic medication or when switching to a new biologic treatment). The study is an extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). The patients will be examined by use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.

The objectives are to explore US as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the US pathology with clinical and laboratory findings.

Conditions

  • Spondyloarthritis
  • Ultrasonography

Interventions

BIOLOGICAL

Anti-TNF alpha therapy

All medical treatment will be standardizes following good medical practice

Sponsors & Collaborators

  • Diakonhjemmet Hospital

    lead OTHER

Principal Investigators

  • Hilde B Hammer, MD, PhD · Diakonhjemmet Hospital

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219257 on ClinicalTrials.gov