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

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.

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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