Targeting Synovitis in Early Rheumatoid Arthritis

NCT00920478 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2009-09-10

No results posted yet for this study

Summary

Patients with rheumatoid arthritis are at risk of developing permanent joint damage and disability. This study hopes to identify the most effective way of using existing arthritis medication to minimise the chances of developing permanent disability. Patients will have their arthritis activity assessed using an ultrasound machine. If there is still evidence of active arthritis the participant's arthritis medication will be increased until the arthritis is in remission. The effectiveness of this approach will be compared to the traditional method of assessing arthritis using clinical examination.

Furthermore, it is extremely important to identify those patients most at risk of aggressive disease. The investigators hope to produce a more accurate measurement of disease prognosis by examining the relationship between a series of blood tests and how well controlled rheumatoid arthritis appears after 18 months of therapy. Some patients will also be asked to donate samples of joint fluid and joint lining for additional analysis.

Conditions

Interventions

OTHER

Musculoskeletal Ultrasound

Gray scale and power doppler - to identify the presence of synovitis

OTHER

28 Joint Disease Activity Score

Clinical assessment of synovitis - composite score incorporating 28 tender joint count, 28 swollen joint count, erythrocyte sedimentation rate and patient global VAS

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER
  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV
  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY
  • Translational Medicine Research Collaboration

    collaborator OTHER
  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Duncan R Porter, MBChB, MRCP · Gartnavel General Hospital, Glasgow

  • James E Dale, MBChB, MRCP · University of Glasgow

  • Iain B McInnes, PhD, FRCP · University of Glasgow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00920478 on ClinicalTrials.gov