Rheumatoid Arthritis Clinical Trial
— TaSEROfficial title:
Targeting Synovitis in Early Rheumatoid Arthritis (TaSER). Intensive Management of Early Rheumatoid Arthritis Using Either Clinical or Musculoskeletal Ultrasound Assessment of Synovitis − a Randomised Study With Blinded Outcome Assessments
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients attending Early RA clinics with newly diagnosed RA or anti-CCP +ve Undifferentiated Arthritis (UA) 2. Active disease (DAS28 > 3.2) 3. DMARD naïve or DMARD monotherapy for less than 6 weeks 4. Aged 18 or more Exclusion Criteria: 1. Significant liver disease and/or abnormality of liver function tests 2. AST / ALT > x2 normal, Alkaline Phosphatase > x2.5 normal 3. Renal impairment - serum creatinine > 200 µmol/l, eGFR < 30 4. Cytopenias - white cell count < 4.0, haemoglobin < 10, platelet < 150 5. Pregnancy or planned pregnancy 6. Contraindication to MRI 7. Other co-morbid condition that in the opinion of the investigator would preclude the use of sequential or combination DMARD therapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Rheumatic Diseases, Glasgow Royal Infirmary | Glasgow | |
United Kingdom | Department of Rheumatology, Gartnavel General Hospital | Glasgow | |
United Kingdom | Department of Rheumatology, Stobhill Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde | Chief Scientist Office of the Scottish Government, Translational Medicine Research Collaboration, University of Glasgow, Wyeth is now a wholly owned subsidiary of Pfizer |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI RAMRIS Erosion Score | Baseline and 18 months | No | |
Primary | 44 Joint Disease Activity Score | Baseline, 3, 6, 9, 12, 15 and 18 months | No | |
Secondary | Plain Xray - Hands and Feet - modified Sharp score | Baseline and 18 months | No | |
Secondary | Health Assessment Questionnaire | Baseline, 3, 6, 9, 12, 15 and 18 months | No | |
Secondary | Euro-Qol 5D | Baseline, 3, 6, 9, 12, 15 and 18 months | No | |
Secondary | EULAR response and remission rates | Baseline and 18 months | No | |
Secondary | Biomarker analysis - correlation between baseline values and 18 month radiological outcomes | Baseline | No | |
Secondary | Adverse event rates | Throughout period of study | Yes |
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