search
Back to results

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)
placebo
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 diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997) Patients between 2 and 19 years of age Patients who are under 16 years of age at onset Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions Exclusion criteria Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product Patients who have received the following treatments within 4 weeks before treatment with the investigational product Surgical treatment (e.g., operation) Plasma exchange therapy"

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
    Efficacy:Percentage of patients in whom effects were maintained
    Safety:Incidence and severity of adverse events and adverse drug reactions
    Pharmacokinetics:The time course of the trough serum MRA concentration

    Secondary Outcome Measures

    Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score
    Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS

    Full Information

    First Posted
    September 2, 2005
    Last Updated
    July 29, 2008
    Sponsor
    Chugai Pharmaceutical
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00144599
    Brief Title
    Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
    Official Title
    A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    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 a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

    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
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MRA(Tocilizumab)
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
    Time Frame
    open-label period
    Title
    Efficacy:Percentage of patients in whom effects were maintained
    Time Frame
    Blind period
    Title
    Safety:Incidence and severity of adverse events and adverse drug reactions
    Time Frame
    whole period
    Title
    Pharmacokinetics:The time course of the trough serum MRA concentration
    Time Frame
    whole period
    Secondary Outcome Measure Information:
    Title
    Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score
    Time Frame
    Open-label period
    Title
    Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS
    Time Frame
    Blind 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 diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997) Patients between 2 and 19 years of age Patients who are under 16 years of age at onset Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions Exclusion criteria Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product Patients who have received the following treatments within 4 weeks before treatment with the investigational product Surgical treatment (e.g., operation) Plasma exchange therapy"
    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

    Learn more about this trial

    Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

    We'll reach out to this number within 24 hrs