Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

NCT ID: NCT01145352

Last Updated: 2014-09-04

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

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-10-31

Brief Summary

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This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.

1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events
2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

Detailed Description

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All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Etanercept (genetical recombination)

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).

Etanercept (genetical recombination)

Intervention Type DRUG

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).

Interventions

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Etanercept (genetical recombination)

All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).

Intervention Type DRUG

Other Intervention Names

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Enbrel

Eligibility Criteria

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Inclusion Criteria

* Patients in active polyarticular JIA (restricted to the case of lack of effect by other treatment) during enrollment period (2.5years).
* Patients receiving Enbrel for JIA as diagnosed by a qualified physician.
* Age 5 - 16 years

Exclusion Criteria

* Patients not administered ENBREL
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 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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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Yokohama City University School of

Tokyo, Japan, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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B1801130

Identifier Type: -

Identifier Source: secondary_id

0881Y1-4689

Identifier Type: -

Identifier Source: org_study_id

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