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Study of MRA in Patients With Rheumatoid Arthritis (RA)

NCT ID: NCT00144651

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

PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2009-06-30

Brief Summary

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This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

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 for 1 year

Interventions

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MRA(Tocilizumab)

8mg/kg/4 weeks for 1 year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
* Patients confirmed to have shown the safety in the preceding study.

Exclusion Criteria

* Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
* Patients who received any of the following treatments between the start of preceding study and the registration of this study.

1. Plasma exchange therapy
2. Surgical treatment (e.g., operation)
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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MRA010JP

Identifier Type: -

Identifier Source: org_study_id