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Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

NCT ID: NCT00144664

Last Updated: 2008-07-30

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

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-10-31

Brief Summary

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This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

Detailed Description

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Conditions

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Systemic Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MRA(Tocilizumab)

Group Type EXPERIMENTAL

MRA(Tocilizumab)

Intervention Type DRUG

Interventions

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MRA(Tocilizumab)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
* Patients aged at least 2 years old and less than 20.
* Patients aged less than 16 years old at time of onset

Exclusion Criteria

* Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product
* Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product
Minimum Eligible Age

2 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Chugai Pharmaceutical

Principal Investigators

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Takahiro Kakehi

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Other Identifiers

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MRA318JP

Identifier Type: -

Identifier Source: org_study_id