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

December 21, 2009 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 MRA213JP

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
8mg/kg/4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
Time Frame: throughout study
throughout study
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
Time Frame: throughout study
throughout study
Pharmacokinetics of the serum MRA concentration
Time Frame: 0W,4W,8W,12W,LOBS
0W,4W,8W,12W,LOBS

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: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

Collaborators and Investigators

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

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

June 1, 2004

Primary Completion (Actual)

August 1, 2005

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)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 21, 2009

Last Verified

December 1, 2009

More Information

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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