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
Summary
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
Eligibility
Minimum age: 4 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Inclusion in this study will be as per the approved indications in the package
insert.
- 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
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