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Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

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 (MRA011JP patients) Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients) Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period Exclusion criteria Patients who were not enrolled by 3 months after completion of the previous study Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

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 compared with before the first infusion of the investigational product (including the previous study)
    Safety:Incidence and severity of adverse events and adverse reactions
    Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks

    Secondary Outcome Measures

    Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks

    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
    NCT00144612
    Brief Title
    Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
    Official Title
    An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chugai Pharmaceutical

    4. Oversight

    5. Study Description

    Brief Summary
    An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

    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
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    MRA(Tocilizumab)
    Intervention Description
    8mg/kg/2weeks
    Primary Outcome Measure Information:
    Title
    Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study)
    Time Frame
    whole period
    Title
    Safety:Incidence and severity of adverse events and adverse reactions
    Time Frame
    whole period
    Title
    Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks
    Time Frame
    0 week and every 2 weeks
    Secondary Outcome Measure Information:
    Title
    Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks
    Time Frame
    0 week and every 2 weeks

    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 (MRA011JP patients) Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients) Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period Exclusion criteria Patients who were not enrolled by 3 months after completion of the previous study Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study
    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

    Citations:
    PubMed Identifier
    24786929
    Citation
    Aoki C, Inaba Y, Choe H, Kaneko U, Hara R, Miyamae T, Imagawa T, Mori M, Oba MS, Yokota S, Saito T. Discrepancy between clinical and radiological responses to tocilizumab treatment in patients with systemic-onset juvenile idiopathic arthritis. J Rheumatol. 2014 Jun;41(6):1171-7. doi: 10.3899/jrheum.130924. Epub 2014 May 1. Erratum In: J Rheumatol. 2014 Jul;41(7):1567.
    Results Reference
    derived
    PubMed Identifier
    24634205
    Citation
    Yokota S, Imagawa T, Mori M, Miyamae T, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Longterm safety and effectiveness of the anti-interleukin 6 receptor monoclonal antibody tocilizumab in patients with systemic juvenile idiopathic arthritis in Japan. J Rheumatol. 2014 Apr;41(4):759-67. doi: 10.3899/jrheum.130690. Epub 2014 Mar 15.
    Results Reference
    derived
    PubMed Identifier
    18358927
    Citation
    Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 Mar 22;371(9617):998-1006. doi: 10.1016/S0140-6736(08)60454-7.
    Results Reference
    derived

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    Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

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