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Trial record 43 of 2721 for:    Rheumatoid Arthritis

Ultrasonography as a Biomarker in Early Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00781989
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : July 8, 2019
Medical Research Council
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualification of Ultrasonography as a Biomarker of Prognosis and Response to Treatment in Early Rheumatoid Arthritis
Study Start Date : September 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Rheumatoid Arthritis patients
Patients with seropositive Rheumatoid Arthritis with symptom onset of less than three years

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
whole blood / serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospital Rheumatology outpatient departments

Inclusion Criteria:

  1. Male and female adults aged 18 years or greater.
  2. 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.
  3. The patient is seropositive for rheumatoid factor (IgM RF measured by agglutination assay) and / or anti−cyclic citrullinated peptides (measured by ELISA).
  4. The subject has provided signed and dated written informed consent prior to admission to the study
  5. The subject is able to understand and comply with protocol requirements, instructions and restrictions.

Exclusion Criteria:

  1. 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.
  2. Current or prior use of biologic drugs ( anti− tumour necrosis factor alpha drugs or rituximab)
  3. As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the subject unfit for the study.
  4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00781989

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United Kingdom
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Medical Research Council
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Principal Investigator: P C Taylor, MA, PhD Imperial College London

Publications of Results:
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Responsible Party: Imperial College London Identifier: NCT00781989     History of Changes
Other Study ID Numbers: CRO1089
Sponsers number: TAYP2013
Funder's number: G0601962
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
early rheumatoid arthritis

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases