Rheumatoid Arthritis Clinical Trial
Official title:
Correlation of Standard Disease Activity Parameters in Rheumatoid Arthritis With Activities of Daily Living Measured With the Step Activity Monitor, Based on the Influence of Etanercept Therapy on the Disease Activity
Data on activities of daily living in patients with rheumatoid arthritis are assessed mainly be the health assessment questionnaire (HAQ). The HAQ generates data by subjective variables. It would be desirable and advantageous to add objective tools reflecting patients' activities to the outcome parameters in rheumatoid arthritis. The StepWatchâ„¢ activity monitor (SAM) in an ankle worn step counter and an accurate instrument to measure real world ambulatory activity. The investigators purpose was to investigate whether activities of daily living measured by SAM increase during a therapy with the TNF-alpha inhibitor etanercept in patients with active rheumatoid arthritis (RA).
In the past decade treatment strategies for rheumatoid arthritis (RA) have changed
dramatically. Today far more therapeutic options are available. Patients are being treated
earlier and more aggressive than in the past.
These processes have had an influence on the outcome of patients with RA and on the way they
are being evaluated.
Outcome variables are disease aspects or consequences that develop over the course of RA.
The HAQ score has been shown to be a good predictor of patients outcome in RA. However, the
HAQ ist a questionnaire and the score is influenced by subjective factors.
The Step Watch Activity monitor (SAM)is a highly accurate accelerometer-based step monitor.
The SAM provides a detailed profile of the number of steps taken by a subject. It is a small
unobtrusive device which is worn laterally at the right ankle. It weights only 65 grams and
uses 2D accelerometry.
The SAM can provide objective information about activities of daily living.
Etanercept is a recombinant fully human TNF-receptor p75-Fc fusion protein. Numerous studies
with etanercept have shown the clinical efficacy. This can be demonstrated by various
disease activity scores (e.g the DAS28). In addition there is strong evidence that
etanercept improves disability measured by the HAQ.
There are only few publications reporting about measuring physical activity in patients with
joint diseases; all of these include patients with osteoarthritis.
Our aim is to include patients with active RA who receive etanercept. These patients are
asked to wear the SAM for 7 days before treatment and 4 weeks and 12 weeks after initiation
of therapy with etanercept. The step activity measured by the SAM will be correlated with
the the clinical sore DAS28 and the HAQ.
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Observational Model: Cohort, Time Perspective: Prospective
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