We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00245934
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : December 14, 2007
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences in injection site reactions based on whether health care professionals or patients administer Enbrel will be assessed and evaluated.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Enbrel

Study Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Time Perspective: Prospective
Official Title: Observational Study With Enbrel in Patients With Rheumatoid Arthritis
Study Start Date : June 2003
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Proven diagnosis of rheumatoid arthritis

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the following points will prevent or restrict participation:

    • Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®
    • Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localized infections
    • Patients with sepsis or risk of sepsis should not be treated
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245934

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedinfoDEU@wyeth.com
More Information

ClinicalTrials.gov Identifier: NCT00245934     History of Changes
Other Study ID Numbers: 101354
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Rheumatoid Arthritis

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