Ultrasonography as a Biomarker in Early Rheumatoid Arthritis

NCT00781989 | Completed

• 3 other identifiers: CRO1089Sponsers number: TAYP2013Funder's number: G0601962
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

early rheumatoid arthritis; biomarkers; ultrasound

Outcome Measures

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.

  one year

Secondary Outcomes (2)

• 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

Study Arms (1)

Rheumatoid Arthritis patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital Rheumatology outpatient departments

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator

Study Sites (1)

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

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• Sreerangaiah D, Grayer M, Fisher BA, Ho M, Abraham S, Taylor PC. Quantitative power Doppler ultrasound measures of peripheral joint synovitis in poor prognosis early rheumatoid arthritis predict radiographic progression. Rheumatology (Oxford). 2016 Jan;55(1):89-93. doi: 10.1093/rheumatology/kev305. Epub 2015 Aug 27.

  PMID: 26316580 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood / serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• P C Taylor, MA, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)