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Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

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

Inclusion criteria RA patients who participated in the previous studies Patients who completed the last observation in the previous studies Patients who were confirmed to have no problems with safety in the previous studies. Exclusion criteria Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product Patients who were not enrolled by 3 months after the last observation day of the previous study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.

    Secondary Outcome Measures

    Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.

    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
    NCT00144586
    Brief Title
    Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP
    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 MRA220JP or MRA221JP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (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

    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 MRA220JP or MRA221JP.

    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
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    MRA(Tocilizumab)
    Intervention Description
    8mg/kg/4 weeks
    Primary Outcome Measure Information:
    Title
    20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.
    Time Frame
    throughout study
    Secondary Outcome Measure Information:
    Title
    Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
    Time Frame
    Week 0, then every 4 Week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria RA patients who participated in the previous studies Patients who completed the last observation in the previous studies Patients who were confirmed to have no problems with safety in the previous studies. Exclusion criteria Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product Patients who were not enrolled by 3 months after the last observation day of the previous study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuji Kimura
    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 MRA220JP or MRA221JP

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