Status:
COMPLETED
Ultrasonography as a Biomarker in Early Rheumatoid Arthritis
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Medical Research Council
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00781989
Start Date
September 1 2008
End Date
April 1 2011
Last Update
July 8 2019
Active Locations (1)
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1
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, United Kingdom, W6 8RF