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

August 6, 2013 updated by: Chugai Pharmaceutical

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: MRA(Tocilizumab)
8mg/kg(i.v.)/4weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
0W,4W,8W,12W,LOBS

Secondary Outcome Measures

Outcome Measure
Time Frame
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
0W,4W,8W,12W,LOBS
Frequency, severity, and seriousness of adverse events and adverse drug reactions
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRA214JP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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