Observational Trial With Enbrel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00488475
First received: June 18, 2007
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Rheumatoid Arthritis
Drug: etanercept

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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%.

  • Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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%.


Secondary Outcome Measures:
  • Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Healthcare Resource Utilization [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Duration of Healthcare Resources Utilization [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Duration of Working Disability [ Time Frame: Baseline, Week 26, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score Based on 28-Joints Count (DAS28) [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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.

  • Swollen Joints Count (SJC) [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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.

  • Tender Joints Count (TJC) [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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.

  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Duration of Morning Stiffness [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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]).

  • Patient Global Assessment of Arthritis Pain [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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).

  • Physician Global Assessment of Disease Activity [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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.

  • Patient Global Assessment of Disease Activity [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: No ]
    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.

  • C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 2, 6, 12, 26, 38, 52 ] [ Designated as safety issue: Yes ]
    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.

  • Fatigue Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 26, 52 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Week 2 up to Week 52 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 4945
Study Start Date: September 2006
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Rheumatoid Arthritis Drug: etanercept
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 Name: Enbrel

Detailed Description:

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Clinical diagnosis of rheumatoid arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitivity against Etanercept
  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: NCT00488475

Locations
Germany
Pfizer Investigational Site
Muenster, NRW, Germany, 48149
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00488475     History of Changes
Other Study ID Numbers: 0881A1-102335, B1801121
Study First Received: June 18, 2007
Results First Received: April 16, 2014
Last Updated: July 25, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 23, 2014