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

NCT ID: NCT00195403

Last Updated: 2013-08-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1014 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-02-29

Brief Summary

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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.

1. Unknown adverse reactions, especially serious adverse reactions
2. Incidences of adverse reactions under routine drug uses
3. Factors that may affect the safety of the drug
4. Factors that may affect the efficacy of the drug

This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403, 0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have been combined into this record.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Etanercept

Intervention Type DRUG

Etanercept 25mg Injection, 2 times/week

Interventions

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Etanercept

Etanercept 25mg Injection, 2 times/week

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Kyunggi-do, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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0881A-101575

Identifier Type: -

Identifier Source: org_study_id