Ultrasonography as a Biomarker in Early Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00781989
First received: October 28, 2008
Last updated: September 29, 2011
Last verified: September 2011

October 28, 2008
September 29, 2011
September 2008
April 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781989 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ultrasonography as a Biomarker in Early Rheumatoid Arthritis
Qualification of Ultrasonography as a Biomarker of Prognosis and Response to Treatment 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood / serum

Non-Probability Sample

hospital Rheumatology outpatient departments

Rheumatoid Arthritis
Not Provided
Rheumatoid Arthritis patients
Patients with seropositive Rheumatoid Arthritis with symptom onset of less than three years
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00781989
CRO1089, Sponsers number: TAYP2013, Funder's number: G0601962
No
Imperial College London
Imperial College London
Medical Research Council
Principal Investigator: P C Taylor, MA, PhD Imperial College London
Imperial College London
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP