Observational Trial With Enbrel
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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 |
- Proportion of patients achieving functional remission determined by FFbH (Funktionsfragebogen Hannover) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Incidences of adverse events in usual care setting [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Differences in adverse event rates between patients with concomitant MTX therapy or specific co-morbidities [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Proportions of patients achieve low disease activity and remission determined by DAS 28 (Disease Activity Score 28) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Physician`s global assessment of disease activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Patient`s global assessment of disease activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 4882 |
| 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 |
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
Inclusion Criteria:
- Clinical diagnosis of rheumatoid arthritis
Exclusion Criteria:
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitivity against Etanercept
Contacts and Locations 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 |
| Last Updated: | May 30, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013