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

Chugai Pharmaceutical241 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

241

Conditions

Rheumatoid Arthritis

Interventions

MRA(Tocilizumab)DRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)

Time frame: 0W,4W,8W,12W,LOBS

Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria

Time frame: 0W,4W,8W,12W,LOBS

Secondary Outcomes

Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set

Time frame: 0W,4W,8W,12W,LOBS

Frequency, severity, and seriousness of adverse events and adverse drug reactions

Time frame: Throughout study

Data from ClinicalTrials.gov

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