Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

This study is currently recruiting participants.

Verified by Wyeth, July 2007

First Received: July 16, 2007 No Changes Posted

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00503139

Purpose

The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives:1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors.2. To confirm the efficacy of Enbrel in the long-term use.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Enbrel (etanercept)	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Convenience Sample, Prospective Study
Official Title:	Long Term Safety and Efficacy From Special Surveillance for Etanercept in Japan

Further study details as provided by Wyeth:

Study Start Date:	June 2007
Estimated Study Completion Date:	March 2008

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria Patients with rheumatoid arthritis(RA) who fulfill all of the following

Patients who are refractory to the treatment.
Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
Patients without a history of or concurrent malignant tumors.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503139

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Japan
	Recruiting
Multiple Cities, Japan

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0881A1-4426
Study First Received:	July 16, 2007
Last Updated:	July 16, 2007
ClinicalTrials.gov Identifier:	NCT00503139 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

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