Clinical trial NCT01388608: Standard Disease Activity Parameters and Step Activity in Patients With Rheumatoid Arthritis Receiving Etanercept
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
etanercept
step activity measure
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with active rheumatoid arthritis (Disease activity score -DAS28 \> 3.2) who are eligible to a treatment with etanercept.
* Age 18 and older
* Male or female

Exclusion Criteria:

* Contraindications against a therapy with etanercept
* Patients not able to comply with the requirements of the protocol

Primary outcomes:
measure: Changes from baseline in the step counts during a therapy with etanercept in patients with active rheumatoid arthritis
timeFrame: at baseline, after 4, and after 12 weeks for
Secondary outcomes:
measure: Correlation of the step counts with the health-assessment-questionnaire and the disease activity measured by DAS28 during a therapy with etanercept
timeFrame: Baseline, week 4 and week 12
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster, Department of Medicine D, Section for rheumatology
name: Peter Willeke, MD
role: PRINCIPAL_INVESTIGATOR
References: