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Study of MRA in Patients With Rheumatoid Arthritis (RA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
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 administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety. Patients confirmed to have shown the safety in the preceding study. Exclusion Criteria: Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug Patients who received any of the following treatments between the start of preceding study and the registration of this study. Plasma exchange therapy Surgical treatment (e.g., operation)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    ACR 20% responder rate compared to the pre-treatment in the preceding study
    Frequency and severity of adverse events and adverse drug reactions

    Secondary Outcome Measures

    Time course of DAS28,compared to the pre-treatment in the preceding study
    Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
    ACR N AUC compared to the pre-treatment in the preceding study
    Time course of the ACR core set variables compared to the pre-treatment in the preceding study

    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
    NCT00144651
    Brief Title
    Study of MRA in Patients With Rheumatoid Arthritis (RA)
    Official Title
    An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2001 (undefined)
    Primary Completion Date
    June 2009 (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 II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

    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 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    135 (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 for 1 year
    Primary Outcome Measure Information:
    Title
    ACR 20% responder rate compared to the pre-treatment in the preceding study
    Time Frame
    throughout study
    Title
    Frequency and severity of adverse events and adverse drug reactions
    Time Frame
    week0,week4,week8,week12,and LOBS
    Secondary Outcome Measure Information:
    Title
    Time course of DAS28,compared to the pre-treatment in the preceding study
    Time Frame
    week 0,week 4,week 8,week 12, LOBS
    Title
    Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
    Time Frame
    week 0,week 4,week 8,week 12, LOBS
    Title
    ACR N AUC compared to the pre-treatment in the preceding study
    Time Frame
    week 0,week 4,week 8,week 12, LOBS
    Title
    Time course of the ACR core set variables compared to the pre-treatment in the preceding study
    Time Frame
    week 0,week 4,week 8,week 12, LOBS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety. Patients confirmed to have shown the safety in the preceding study. Exclusion Criteria: Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug Patients who received any of the following treatments between the start of preceding study and the registration of this study. Plasma exchange therapy Surgical treatment (e.g., operation)
    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 in Patients With Rheumatoid Arthritis (RA)

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