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PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

NCT ID: NCT00380601

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-02-28

Brief Summary

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An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

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

* Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
* Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
* Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

Exclusion Criteria

* Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug
* Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
* Subjected to any of the following within 4 weeks before administration of the study drug:

1. Surgical treatment (operations,etc.).
2. Plasma exchange method
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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Chugai Pharmaceutical Co.,Ltd.

Principal Investigators

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Yuji Kimura

Role: STUDY_DIRECTOR

Chugai Pharmaceutical Co., Ltd. Research Dept.1

Locations

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Chugoku region

Chugoku, , Japan

Site Status

Chukyo region

Chukyo, , Japan

Site Status

Hokkaido region

Hokkaido, , Japan

Site Status

Hokuriku region

Hokuriku, , Japan

Site Status

Kansai region

Kansai, , Japan

Site Status

Kanto region

Kanto, , Japan

Site Status

Kousinetsu region

Kousinetsu, , Japan

Site Status

Kyushu region

Kyushu, , Japan

Site Status

Sikoku region

Sikoku, , Japan

Site Status

Tohoku region

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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MRA225JP

Identifier Type: -

Identifier Source: org_study_id