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NCT Number: NCT00781989

Ultrasonography as a Biomarker in Early Rheumatoid Arthritis

This is a prospective, observational study designed to look at ultrasound images of the joint at baseline and over time, and investigate whether there is a correlation between ultrasound images and progression of disease. The researchers wish also to see if ultrasound can be used as a tool to predict progression of Rheumatoid Arthritis in patients with early disease who have not taken biologics therapy. In addition, the researchers wish to investigate whether peripheral blood "biomarkers"can be identified that predict the progression of erosive disease in early rheumatoid arthritis, with the intention of testing the most promising biomarkers in future clinical trials.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital

London, W6 8RF, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female adults aged 18 years or greater.
  • The subject has a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR) with onset of symptomatology of less than 3 years.
  • The patient is seropositive for rheumatoid factor (IgM RF measured by agglutination assay) and / or anti-cyclic citrullinated peptides (measured by ELISA).
  • The subject has provided signed and dated written informed consent prior to admission to the study
  • The subject is able to understand and comply with protocol requirements, instructions and restrictions.

Exclusion criteria

  • Past or present disease, which as judged by the investigator, may affect both the subject's participation in the study or outcome of the study. These diseases include but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease.
  • Current or prior use of biologic drugs ( anti- tumour necrosis factor alpha drugs or rituximab)
  • As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the subject unfit for the study.
  • The subject's RA does not have a clearly recordable time of onset (within a 6 month period) as determined by either the notes or from the history taken from the patient by the physician responsible

Treatment and study plan

Primary outcomes

  1. Correlation between Power Doppler Ultrasound (PDUS)score at baseline and progression of erosions at one year, as assessed by xray and high frequency ultrasound.

    Time frame: one year

Secondary outcomes

  1. Correlation between average Power Doppler Ultrasound (PDUS) score (at 0,6 and 12 months) and progression of erosions at one year,as assessed by xray and high frequency ultrasound.

    Time frame: one year

  2. Correlation between CRP level at baseline and progression of erosions at one year,as assessed by xray and high frequency ultrasound.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

Qualification of Ultrasonography as a Biomarker of Prognosis and Response to Treatment in Early Rheumatoid Arthritis

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2008
Registry last updated
Jul 8, 2019

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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