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Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

NCT ID: NCT00144625

Last Updated: 2009-12-23

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

2005-02-28

Study Completion Date

2009-06-30

Brief Summary

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This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

Detailed Description

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Conditions

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Polyarticular 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

Group Type EXPERIMENTAL

MRA(Tocilizumab)

Intervention Type DRUG

8mg/kg/4weeks

Interventions

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MRA(Tocilizumab)

8mg/kg/4weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
* the patients who did not have problems with safety in the previous study"

Exclusion Criteria

* Patients who were not enrolled by 3 months after completion of the previous study
* Patients who received any of the following since completion of the previous study until initiation of treatment in the present study

1. DMARDs or immunosuppressants
2. Intravenous and intramuscular injection of corticosteroids
3. Plasma exchange therapy
4. Other drugs and therapies that may affect evaluation of drug efficacy
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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MRA319JP

Identifier Type: -

Identifier Source: org_study_id