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Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MRA (Tocilizumab)
current treatment
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 Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987. With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis. Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL. Exclusion criteria Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug. Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug. The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug. Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    1

    2

    Arm Description

    continue current treatment

    Outcomes

    Primary Outcome Measures

    Change in the erosion score, as determined by the modified Sharp method.
    Frequency and severity of adverse events and adverse drug reactions

    Secondary Outcome Measures

    Change in the erosion score
    Changes in the joint space narrowing score and total Sharp score

    Full Information

    First Posted
    September 2, 2005
    Last Updated
    January 30, 2009
    Sponsor
    Chugai Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00144508
    Brief Title
    Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)
    Official Title
    An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    May 2004 (Actual)
    Study Completion Date
    February 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chugai Pharmaceutical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.

    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
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    306 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Other
    Arm Description
    continue current treatment
    Intervention Type
    Drug
    Intervention Name(s)
    MRA (Tocilizumab)
    Intervention Description
    8mg /kg /4week for 52 weeks
    Intervention Type
    Other
    Intervention Name(s)
    current treatment
    Intervention Description
    continue current treatment
    Primary Outcome Measure Information:
    Title
    Change in the erosion score, as determined by the modified Sharp method.
    Time Frame
    week 52
    Title
    Frequency and severity of adverse events and adverse drug reactions
    Time Frame
    throughout study
    Secondary Outcome Measure Information:
    Title
    Change in the erosion score
    Time Frame
    week 28
    Title
    Changes in the joint space narrowing score and total Sharp score
    Time Frame
    week 28, 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987. With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis. Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL. Exclusion criteria Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug. Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug. The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug. Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).
    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

    Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

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