A Drug Use Investigation of ENBREL for Post-Marketing Surveillance (PMS) for RA and PsA

This study is currently recruiting participants.

Verified by Wyeth, December 2007

First Received: September 12, 2005 Last Updated: December 21, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195403

Purpose

The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulation.

Unknown adverse reactions, especially serious adverse reactions
Incidences of adverse reactions under routine drug uses
Factors that may affect the safety of the drug
Factors that may affect the efficacy of the drug

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Etanercept	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Drug Use Investigation of Enbrel for Post-Marketing Surveillance

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	May 2004
Estimated Study Completion Date:	October 2009

Groups/Cohorts	Assigned Interventions
1	Drug: Etanercept Etanercept 25mg Injection, 2 times/week

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary care clinic, secondary and tertiary medical centers

Criteria

Inclusion Criteria

Rheumatoid Arthritis

Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate
Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX

Psoriatic Arthritis

Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs

Exclusion Criteria

Patients to whom Enbrel is contraindicated as per the local labeling
Patients with known hypersensitivity to Enbrel or any component of the product
Patients with sepsis or risk of sepsis
Patients with active infections including chronic or localized infections such as tuberculosis. (Treatment of Enbrel should not be initiated.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195403

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Korea, Republic of
	Recruiting
Seoul, Korea, Republic of, 137-807
	Recruiting
Seoul, Korea, Republic of, 133-792
	Recruiting
Seoul, Korea, Republic of, 120-752
	Recruiting
Kyunggi-do, Korea, Republic of, 463-712

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A-101575
Study First Received:	September 12, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00195403 History of Changes
Health Authority:	Korea: Food and Drug Administration

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 06, 2009