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

NCT01388608 | Completed

• 1 other identifier: StepcountETN
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; etanercept; step activity measure

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in the step counts during a therapy with etanercept in patients with active rheumatoid arthritis

  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.

  at baseline, after 4, and after 12 weeks for

Secondary Outcomes (1)

• Correlation of the step counts with the health-assessment-questionnaire and the disease activity measured by DAS28 during a therapy with etanercept

  Baseline, week 4 and week 12

Study Arms (1)

RA patients receiving etanercept

Patients with active rheumatoid arthritis (RA) who are eligible to a treatment with etanercept.

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Willeke, MD

  University Hospital Muenster, Department of Medicine D, Section for rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 6, 2011
• Study Start: June 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 21, 2013

Record last verified: 2011-07

Locations

DE (1)