Ultrasonography as a Biomarker in Early Rheumatoid Arthritis

NCT ID: NCT00781989

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rheumatoid Arthritis patients

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

P C Taylor, MA, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 26316580 (View on PubMed)

Other Identifiers

Sponsers number: TAYP2013

Identifier Type: -

Identifier Source: secondary_id

Funder's number: G0601962

Identifier Type: -

Identifier Source: secondary_id

CRO1089

Identifier Type: -

Identifier Source: org_study_id