Rheumatoid Arthritis Clinical Trial
Official 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.
PURPOSE 1 − to determine whether it is possible to achieve better control of inflammatory
joint disease activity in early rheumatoid arthritis by using musculoskeletal ultrasound,
instead of clinical examination, to identify the presence, or absence, of synovitis
NULL HYPOTHESIS 1 − using musculoskeletal ultrasound to confirm / refute the presence of
ongoing synovitis will NOT allow better control of early rheumatoid arthritis nor prevent
progression of destructive joint disease despite patients receiving more intensive disease
modifying therapy regimens
PURPOSE 2 − to determine whether baseline measures of certain biochemical and pathological
factors, associated with the development of inflammatory synovitis, are predictive of
response to therapy in early rheumatoid arthritis and short term outcome measures of
inflammatory joint disease activity, functional ability and quality of life
NULL HYPOTHESIS 2 − serial measures of biochemical and pathological factors, associated with
the development of inflammatory synovitis, will NOT correlate with short term outcome
measures of disease activity and therefore cannot be used to predict a patient's prognosis
nor identify those at risk of progressive, destructive joint disease
TRIAL DESIGN − randomised, prospective single blinded trial of treatment strategy with a
nested study correlating baseline measures and 18 month outcomes
Investigators will not be blinded to treatment group. Treatment decisions and escalation of
therapy will be dictated by a standardised protocol. The sequence of therapy escalation will
be identical for both groups. The groups will differ on the threshold needed to progress to
the next treatment step
Assessors of disease activity, radiological and pathological outcomes will be blinded to
treatment group and their findings will form the basis of each groups final outcome measures
TREATMENT PROTOCOL − the sequence of therapy escalation will be the same for each group. The
groups differ by the 'trigger' required to progress to the next treatment step. Therapy will
escalated in each group if the measured disease activity exceeds that groups threshold
trigger. Changes in DMARD therapy doses and/or combinations take three months to reach
maximum effect; therefore, at least a three month gap will be left between each treatment
escalation
PRIMARY OUTCOME MEASURE
1. Magnetic Resonance Imaging of Dominant Wrist − baseline and 18 months. Images will be
scored using the OMERACT RAMRIS(Rheumatoid Arthritis Magnetic Resonance Imaging Score)
atlas. The change in each patient's synovitis and erosion scores will be pooled and
compared for each intervention group
2. 44 joint Disease Activity Score - Mean change of DAS44 with time will represent the
rate of response to treatment. Mean area under curve DAS44 will represent overall level
of disease activity throughout the study period
SECONDARY OUTCOME MEASURES
1. European League Against Rheumatism Response Rates − A EULAR Good response is defined as
a greater than 1.2 change in DAS44 and a final DAS44 less than 2.4. Disease remission
is defined as DAS44 less than 1.6
2. Functional Measures − Health Assessment Questionnaire and EuroQoL−5D questionnaires at
enrollment and then every 3 months.
3. Plain Xrays − plain xrays of hands, wrists and feet at baseline and 18 months. Change
in Sharp score between baseline and 18 month films will be reported
4. Biomarker analysis − analyses will include specific genetic factors(genomic DNA), gene
expression (RNA analysis), novel autoantibody assays, cytokine / emerging inflammatory
protein profiling, lipid / lipoprotein based markers, metabolic assays and assessment
of bone and cartilage turnover markers.
Samples will be collected at baseline, 3 months and 12 months (if not commenced on
etanercept), immediately before commencing etanercept, 3 months and 6 months after
commencing etanercept and 3 months after cessation. Final disease outcome measures for each
patient will be correlated with baseline biomarker values to determine if any predictive
relationships exist.
All values will be entered into a logistical regression analysis to try and create a
statistical predictive model. Serial biomarker analyses will demonstrate how the different
components of the pathogenetic process respond to the different stages of DMARD therapy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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