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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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rheumatoid arthritis juvenile rheumatoid arthritis

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Enbrel (Etanercept)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0881A-101511

Identifier Type: -

Identifier Source: org_study_id