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Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

NCT ID: NCT00144534

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

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

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 MRA213JP.

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/4 weeks

Interventions

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MRA (Tocilizumab)

8mg/kg/4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
* In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion Criteria

* Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
* Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
* Have not been registered by 3 months after the full code-breaking of the preceding study
* Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
* Treated surgically (except for local surgery) within 4 weeks before administration of the study drug
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 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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MRA215JP

Identifier Type: -

Identifier Source: org_study_id