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Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

NCT ID: NCT00144547

Last Updated: 2013-08-09

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

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

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 and efficacy of MRA in patients with RA who participated in Study MRA012JP.

Detailed Description

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Conditions

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Rheumatoid 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(i.v.)/4weeks

Interventions

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MRA(Tocilizumab)

8mg/kg(i.v.)/4weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must suffer from RA, and must have participated in the preceding study.
* Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion Criteria

* Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
* Patients who have not been registered by 3 months after week 52 of the preceding study
Minimum Eligible Age

20 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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Responsibility Role SPONSOR

Principal Investigators

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Takahiro Kakehi

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Other Identifiers

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MRA214JP

Identifier Type: -

Identifier Source: org_study_id