Rheumatoid ArthritisNCT01388608
Standard Disease Activity Parameters and Step Activity in Patients With Rheumatoid Arthritis Receiving Etanercept
An observational study of Rheumatoid Arthritis, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with active rheumatoid arthritis, who are eligible to a treatment with etanercept according to the local german guidelines
Who may be able to join
- 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
Who cannot join
- Contraindications against a therapy with etanercept
- Patients not able to comply with the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
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 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).
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, etanercept, step activity measure
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RA patients receiving etanercept | Patients with active rheumatoid arthritis (RA) who are eligible to a treatment with etanercept. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Baseline, week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJun 2009
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Willeke, MD, Principal investigator, University Hospital Muenster, Department of Medicine D, Section for rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388608
- Sponsor's protocol ID
- StepcountETN
- Status last verified
- Jul 2011
- First submitted
- 28 Jun 2011
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01388608
- Acronym / sponsor ID
- StepcountETN
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, etanercept, step activity measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA patients receiving etanercept | – | –Patients with active rheumatoid arthritis (RA) who are eligible to a treatment with etanercept. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active rheumatoid arthritis, who are eligible to a treatment with etanercept according to the local german guidelines
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindications against a therapy with etanercept
- Patients not able to comply with the requirements of the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Willeke, MD principal investigator
University Hospital Muenster, Department of Medicine D, Section for rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.