Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

December 21, 2009 updated by: Chugai Pharmaceutical

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP

This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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

2 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
  • the patients who did not have problems with safety in the previous study"

Exclusion criteria

  • Patients who were not enrolled by 3 months after completion of the previous study

  • Patients who received any of the following since completion of the previous study until initiation of treatment in the present study

    1. DMARDs or immunosuppressants
    2. Intravenous and intramuscular injection of corticosteroids
    3. Plasma exchange therapy
    4. Other drugs and therapies that may affect evaluation of drug efficacy

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/4weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
Time Frame: every 3 months
every 3 months
Safety:Incidence and severity of adverse events and adverse drug reactions
Time Frame: whole period
whole period
Pharmacokinetics:The time course of the trough values for the serum MRA concentration
Time Frame: whole period
whole period

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each variable of the JIA core set, CRP, pain every 3M, LOBS
Time Frame: every 3 months
every 3 months

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

February 1, 2005

Primary Completion (Actual)

July 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

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRA319JP

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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