Text Size

Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00245934
First received: October 26, 2005
Last updated: December 12, 2007
Last verified: December 2007
History of Changes
  Purpose

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 Intervention
Rheumatoid Arthritis
 Drug: Enbrel

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study With Enbrel in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

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

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 1500
Study Start Date: June 2003
Study Completion Date: July 2005
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245934

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

No publications provided

ClinicalTrials.gov Identifier: NCT00245934     History of Changes
Other Study ID Numbers: 101354
Study First Received: October 26, 2005
Last Updated: December 12, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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 May 21, 2013