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

Primary Purpose

Polyarticular Juvenile Idiopathic Arthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MRA(Tocilizumab)
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyarticular Juvenile Idiopathic Arthritis

Eligibility Criteria

2 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 2, 2005
    Last Updated
    December 21, 2009
    Sponsor
    Chugai Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00144625
    Brief Title
    Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    July 2005 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chugai Pharmaceutical

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polyarticular Juvenile Idiopathic Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    MRA(Tocilizumab)
    Intervention Description
    8mg/kg/4weeks
    Primary Outcome Measure Information:
    Title
    Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
    Time Frame
    every 3 months
    Title
    Safety:Incidence and severity of adverse events and adverse drug reactions
    Time Frame
    whole period
    Title
    Pharmacokinetics:The time course of the trough values for the serum MRA concentration
    Time Frame
    whole period
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 DMARDs or immunosuppressants Intravenous and intramuscular injection of corticosteroids Plasma exchange therapy Other drugs and therapies that may affect evaluation of drug efficacy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Takahiro Kakehi
    Organizational Affiliation
    Chugai Pharmaceutical
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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