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

Imperial College London1 site in 1 country101 target enrollmentSeptember 2008

ConditionsRheumatoid Arthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Imperial College London
Enrollment: 101
Locations: 1
Primary Endpoint: Correlation between Power Doppler Ultrasound (PDUS)score at baseline and progression of erosions at one year, as assessed by xray and high frequency ultrasound.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

April 2011

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Imperial College London

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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