Observational Trial With Enbrel

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 18, 2007
Last updated: May 30, 2013
Last verified: May 2013

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:
  • Proportion of patients achieving functional remission determined by FFbH (Funktionsfragebogen Hannover) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


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


Inclusion Criteria:

  • Clinical diagnosis of rheumatoid arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitivity against Etanercept
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488475

Pfizer Investigational Site
Muenster, NRW, Germany, 48149
Sponsors and Collaborators
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
Last Updated: May 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
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
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 April 17, 2014