Standard Disease Activity Parameters and Step Activity in Patients With Rheumatoid Arthritis Receiving Etanercept

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01388608
First received: June 28, 2011
Last updated: August 20, 2013
Last verified: July 2011
  Purpose

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).


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Changes from baseline in the step counts during a therapy with etanercept in patients with active rheumatoid arthritis [ Time Frame: at baseline, after 4, and after 12 weeks for ] [ Designated as safety issue: No ]
    During the therapy with etanercept steps will be counted by the Step watch monitor (SAM) for 7 days before therapy(baseline), after 4 weeks, and after 12 weeks.


Secondary Outcome Measures:
  • Correlation of the step counts with the health-assessment-questionnaire and the disease activity measured by DAS28 during a therapy with etanercept [ Time Frame: Baseline, week 4 and week 12 ] [ Designated as safety issue: No ]

    The results of the step watch monitor will be correlated to the results of the the health-assessment-questionnaire (HAQ) and DAS28 under the therapy with etanercept.

    We will measure the step activity by SAM at basline, week 4 and week 12 after initiation of etanercept. At the same time we will will measure the health-assessment-questionnaire (HAQ)and the disease activity score (DAS28).



Enrollment: 28
Study Start Date: June 2009
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA patients receiving etanercept
Patients with active rheumatoid arthritis (RA) who are eligible to a treatment with etanercept.

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

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388608

Locations
Germany
University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Peter Willeke, MD University Hospital Muenster, Department of Medicine D, Section for rheumatology
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01388608     History of Changes
Other Study ID Numbers: StepcountETN
Study First Received: June 28, 2011
Last Updated: August 20, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
rheumatoid arthritis
etanercept
step activity measure

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014