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Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Enbrel (Etanercept) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth


This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.

Clinical Details

Official title: A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).

Study design: Prospective


Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Inclusion in this study will be as per the approved indications in the package


- Patients with moderately to severely active RA.

- Children with JRA who have had an inadequate response to one or more DMARDs.

Exclusion Criteria:

- Known hypersensitivity to etanercept or any of its components.

- Known significant concurrent medical disease, including:

- Congestive heart failure, uncontrolled angina pectoris, recent history of

myocardial infarction

- Cancer or history of cancer

- Active infection

- Sepsis or risk of sepsis

- Active tuberculosis or a past history of tuberculosis

- Pancytopenia

- Females who are pregnant, breast feeding or at risk of pregnancy and not using a

medically acceptable form of contraception.

- Patients who are planning to undergo elective surgery during the study period.

Locations and Contacts

Additional Information

Starting date: March 2004
Ending date: February 2006
Last updated: December 11, 2007

Page last updated: June 20, 2008

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