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Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Primary Purpose

Systemic 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 Systemic Juvenile Idiopathic Arthritis

Eligibility Criteria

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

Inclusion criteria Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997) Patients aged at least 2 years old and less than 20. Patients aged less than 16 years old at time of onset Exclusion criteria Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    MRA(Tocilizumab)

    Outcomes

    Primary Outcome Measures

    Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
    Safety:Incidence and severity of adverse events and adverse drug reactions
    Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for 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 evaluation endpoint in the JIA core set, CRP, pain up to LOBS

    Full Information

    First Posted
    September 2, 2005
    Last Updated
    July 29, 2008
    Sponsor
    Chugai Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00144664
    Brief Title
    Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
    Official Title
    An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    April 2005 (Actual)
    Study Completion Date
    October 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chugai Pharmaceutical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic 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
    Arm Description
    MRA(Tocilizumab)
    Intervention Type
    Drug
    Intervention Name(s)
    MRA(Tocilizumab)
    Primary Outcome Measure Information:
    Title
    Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
    Time Frame
    whole period
    Title
    Safety:Incidence and severity of adverse events and adverse drug reactions
    Time Frame
    whole period
    Title
    Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for 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 evaluation endpoint in the JIA core set, CRP, pain up to LOBS
    Time Frame
    whole period

    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 Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997) Patients aged at least 2 years old and less than 20. Patients aged less than 16 years old at time of onset Exclusion criteria Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product
    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

    Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

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