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Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

Primary Purpose

Rheumatoid 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 Rheumatoid Arthritis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Patients must suffer from RA, and must have participated in the preceding study. Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography. Exclusion criteria Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug Patients who have not been registered by 3 months after week 52 of the preceding study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)
    Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria

    Secondary Outcome Measures

    Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
    Frequency, severity, and seriousness of adverse events and adverse drug reactions

    Full Information

    First Posted
    September 2, 2005
    Last Updated
    August 6, 2013
    Sponsor
    Chugai Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00144547
    Brief Title
    Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP
    Official Title
    An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chugai Pharmaceutical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA012JP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid 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
    241 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    MRA(Tocilizumab)
    Intervention Description
    8mg/kg(i.v.)/4weeks
    Primary Outcome Measure Information:
    Title
    Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)
    Time Frame
    0W,4W,8W,12W,LOBS
    Title
    Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria
    Time Frame
    0W,4W,8W,12W,LOBS
    Secondary Outcome Measure Information:
    Title
    Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
    Time Frame
    0W,4W,8W,12W,LOBS
    Title
    Frequency, severity, and seriousness of adverse events and adverse drug reactions
    Time Frame
    Throughout study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria Patients must suffer from RA, and must have participated in the preceding study. Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography. Exclusion criteria Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug Patients who have not been registered by 3 months after week 52 of the preceding 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

    Learn more about this trial

    Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

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