Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

This study has been completed.

First Received: October 26, 2005 Last Updated: December 12, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00245934

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

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

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

Further study details as provided by Wyeth:

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

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany, MedinfoDEU@wyeth.com

More Information

No publications provided

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

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009