- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00488475
Observational Trial With Enbrel
July 25, 2014 updated by: Pfizer
A 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness Evaluation
The diagnosis, evaluation and treatment of rheumatoid arthritis (RA) continue to undergo rapid change.
Randomized controlled trials such as the TEMPO study have demonstrated the efficacy and safety of the combination of etanercept and methotrexate.
Importantly, the TEMPO study showed that patients treated with etanercept and methotrexate could reach the newer therapeutic goals of low disease activity and remission, and that the physicians, patients, and payers are no longer prepared to accept the goal of "Reduction of symptoms".
RCT are important and powerful tools in assessing efficacy and safety but have their limitations in terms of generalisability.
In order to assess health economics, clinical effectiveness and safety of etanercept, they need to be measured by performing observational studies of unselected patients.
This study aims to provide a holistic assessment of patients receiving etanercept in a real world setting.
This will include centers that would not normally take part in RCT.
The study will assess treatment with etanercept with descriptive statistics of the following parameters: Health economic, Safety, Effectiveness.
In addition, there was a previous study of similar design, but of only 3 months duration (101354), which will allow comparison with historical data.
Since previous study, there have been a number of significant changes: Introduction of a new formulation for etanercept (Enbrel® 50mg · once weekly), Definition of early RA has been modified to short disease duration (from 3 months to 1 year).
Study Overview
Detailed Description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study Type
Observational
Enrollment (Actual)
4945
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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NRW
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Muenster, NRW, Germany, 48149
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial.
These patients must have a proven diagnosis of Rheumatoid Arthritis
Description
Inclusion Criteria:
- Clinical diagnosis of rheumatoid arthritis
Exclusion Criteria:
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitivity against Etanercept
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with Rheumatoid Arthritis
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The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany.
The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26
Time Frame: Week 26
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Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days.
Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0).
Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranging between 0-100; higher score indicates better daily activities.
FFbH functional remission is defined as FFbH functional capacity of >= 83%.
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Week 26
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Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52
Time Frame: Week 52
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Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days.
Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0).
Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100%) / (2 * number of answered questions), ranging between 0-100; higher score indicates better daily activities.
FFbH functional remission is defined as FFbH functional capacity of >= 83%.
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Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
Time Frame: Baseline, Week 26, Week 52
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value.
The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
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Baseline, Week 26, Week 52
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Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)
Time Frame: Baseline, Week 26, Week 52
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed).
Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile.
EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state.
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Baseline, Week 26, Week 52
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Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)
Time Frame: Baseline, Week 26, Week 52
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WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit.
It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment).
These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
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Baseline, Week 26, Week 52
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Healthcare Resource Utilization
Time Frame: Baseline, Week 26, Week 52
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Participants' utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations.
At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented.
After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation.
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Baseline, Week 26, Week 52
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Duration of Healthcare Resources Utilization
Time Frame: Baseline, Week 26, Week 52
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Participants' duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations.
At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented.
After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation.
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Baseline, Week 26, Week 52
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Duration of Working Disability
Time Frame: Baseline, Week 26, Week 52
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Duration of working disability was assessed as number of days a participant was disable to work.
Duration of work disability was considered as "0" if participant was not disable to work during period of assessment.
At baseline, participants' duration of working disability during last 12 months before enrollment into the study was documented.
After enrollment, participants' duration of working disability was documented for last 6 months after previous documentation.
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Baseline, Week 26, Week 52
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Disease Activity Score Based on 28-Joints Count (DAS28)
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]).
Total score range: 0 to 10, higher score indicated more disease activity.
DAS28 less than (<) 2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than or equal to (>=) 3.2 to <=5.1 = moderate disease activity, DAS28 greater than (>) 5.1 = high disease activity.
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Baseline, Week 2, 6, 12, 26, 38, 52
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Swollen Joints Count (SJC)
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.
The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
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Baseline, Week 2, 6, 12, 26, 38, 52
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Tender Joints Count (TJC)
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.
The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
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Baseline, Week 2, 6, 12, 26, 38, 52
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Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hour.
A higher rate is consistent with inflammation.
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Baseline, Week 2, 6, 12, 26, 38, 52
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Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)
Time Frame: Week 2, 6, 12, 26, 38, 52
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DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]).
Total score range: 0 to 10, higher score indicated more disease activity.
DAS28 defined remission was classified as a score of <2.6.
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Week 2, 6, 12, 26, 38, 52
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Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)
Time Frame: Week 2, 6, 12, 26, 38, 52
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The DAS28-based European League Against Rheumatism (EULAR) response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached (final values).
Good responders: change from baseline >1.2 with DAS28 final value <=3.2; moderate responders: change from baseline >1.2 with DAS28 final values >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values <=3.2 and >3.2 to <=5.1; non-responders: change from baseline <=0.6 with DAS28 final values <=3.2, >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values >5.1.
Good and moderate responders were considered to have DAS28 response.
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Week 2, 6, 12, 26, 38, 52
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Duration of Morning Stiffness
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If stiffness persisted the entire day, 999 minutes was recorded [largest value possible to document] which may also include values up to 1440 minutes [= complete day]).
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Baseline, Week 2, 6, 12, 26, 38, 52
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Patient Global Assessment of Arthritis Pain
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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Participants assessed arthritis pain using a 0 mm - 100 mm Visual Analog Scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
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Baseline, Week 2, 6, 12, 26, 38, 52
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Physician Global Assessment of Disease Activity
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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Physician global assessment of disease activity was measured on a 0 mm to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100mm = maximum possible disease activity.
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Baseline, Week 2, 6, 12, 26, 38, 52
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Patient Global Assessment of Disease Activity
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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Patient global assessment of disease activity was measured using a 100 mm Visual Analog Scale (VAS) ranging from 0 mm= very good to 100 mm = very bad.
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Baseline, Week 2, 6, 12, 26, 38, 52
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C-Reactive Protein (CRP)
Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Baseline, Week 2, 6, 12, 26, 38, 52
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Fatigue Visual Analog Scale (VAS)
Time Frame: Baseline, Week 26, 52
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Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
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Baseline, Week 26, 52
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28)
Time Frame: Week 2, 6, 12, 26, 38, 52
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DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]).
Total score range: 0 to 10, higher score indicated more disease activity.
DAS28 defined low disease activity was classified as a score of <=3.2.
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Week 2, 6, 12, 26, 38, 52
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Week 2 up to Week 52
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs included SAEs as well as non-serious AEs which occurred during the study.
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Week 2 up to Week 52
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy
Time Frame: Week 2 up to Week 52
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Participants with or without concomitant methotrexate (MTX) treatment were reported for AEs or SAEs.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Week 2 up to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (ACTUAL)
April 1, 2013
Study Completion (ACTUAL)
April 1, 2013
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 19, 2007
First Posted (ESTIMATE)
June 20, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
August 1, 2014
Last Update Submitted That Met QC Criteria
July 25, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- 0881A1-102335
- B1801121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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