Standard Disease Activity Parameters and Step Activity in Patients With Rheumatoid Arthritis Receiving Etanercept
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      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 StepWatch™ 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).
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with active rheumatoid arthritis, who are eligible to a treatment with etanercept
        according to the local german guidelines
      
Keywords: rheumatoid arthritis; etanercept; step activity measure