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
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualification of Ultrasonography as a Biomarker of Prognosis and Response to Treatment in Early Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

whole blood / serum


Enrollment: 101
Study Start Date: September 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid Arthritis patients
Patients with seropositive Rheumatoid Arthritis with symptom onset of less than three years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospital Rheumatology outpatient departments

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781989

Locations
United Kingdom
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Medical Research Council
Investigators
Principal Investigator: P C Taylor, MA, PhD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00781989     History of Changes
Other Study ID Numbers: CRO1089, Sponsers number: TAYP2013, Funder's number: G0601962
Study First Received: October 28, 2008
Last Updated: September 29, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
early rheumatoid arthritis
biomarkers
ultrasound

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014