N/A
N=4,945
Observational Trial With Enbrel
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00488475 ↗Enrolled (actual)
4,945
Serious AEs
13.3%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 — 36.4 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 |
36.4 | — |
| PRIMARY Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52 |
41.5 | — |
| SECONDARY Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
53.1; 66.5; 70.0 | — |
| SECONDARY Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) |
0.579; 0.748; 0.782 | — |
| SECONDARY Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) |
22.5; 49.5; 54.1; 60.7; 9.4; 31.1 | — |
| SECONDARY Healthcare Resource Utilization |
7.4; 6.0; 3.1; 0.9; 0.4; 0.1 | — |
| SECONDARY Duration of Healthcare Resources Utilization |
4.0; 4.0; 2.0; 7.0; 0.0; 0.0 | — |
| SECONDARY Duration of Working Disability |
0.0; 0.0; 0.0 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count (DAS28) |
5.4; 4.2; 3.9; 3.7; 3.6; 3.4 | — |
| SECONDARY Swollen Joints Count (SJC) |
7.0; 4.5; 3.4; 3.0; 2.6; 2.4 | — |
| SECONDARY Tender Joints Count (TJC) |
9.7; 6.5; 5.0; 4.4; 3.9; 3.5 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
32.3; 24.4; 24.0; 24.0; 23.6; 23.1 | — |
| SECONDARY Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28) |
15.1; 20.8; 24.9; 28.3; 32.3; 35.2 | — |
| SECONDARY Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28) |
60.7; 69.7; 72.9; 77.1; 78.2; 81.7 | — |
| SECONDARY Duration of Morning Stiffness |
60.0; 30.0; 20.0; 15.0; 15.0; 10.0 | — |
| SECONDARY Patient Global Assessment of Arthritis Pain |
64.6; 45.2; 39.2; 36.9; 35.3; 33.2 | — |
| SECONDARY Physician Global Assessment of Disease Activity |
61.7; 43.6; 35.6; 31.8; 30.1; 27.1 | — |
| SECONDARY Patient Global Assessment of Disease Activity |
64.0; 46.6; 39.9; 37.0; 34.9; 32.6 | — |
| SECONDARY C-Reactive Protein (CRP) |
2.1; 1.2; 1.3; 1.2; 1.2; 1.2 | — |
| SECONDARY Fatigue Visual Analog Scale (VAS) |
59.8; 36.0; 32.3 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of rheumatoid arthritis
Exclusion Criteria
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitivity against Etanercept
Data sourced from ClinicalTrials.gov (NCT00488475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.