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PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Japan
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:

  • Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
  • Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
  • Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

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 Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug

  • Subjected to any of the following within 4 weeks before administration of the study drug:

    1. Surgical treatment (operations,etc.).
    2. Plasma exchange method

Sites / Locations

  • Chugoku region
  • Chukyo region
  • Hokkaido region
  • Hokuriku region
  • Kansai region
  • Kanto region
  • Kousinetsu region
  • Kyushu region
  • Sikoku region
  • Tohoku region

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Frequency of ACR 20％ improvement at the final visit

Secondary Outcome Measures

Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.
Time course of DAS28 to the final visit.
Time course of steroid sparing effect from first visit to final visit.

Full Information

First Posted
September 25, 2006
Last Updated
December 22, 2009
Sponsor
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00380601
Brief Title
PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)
Official Title
An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chugai Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

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
20 (Anticipated)

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
Frequency of ACR 20％ improvement at the final visit
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.
Time Frame
throughout study
Title
Time course of DAS28 to the final visit.
Time Frame
throughout study
Title
Time course of steroid sparing effect from first visit to final visit.
Time Frame
throughout study

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 Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study 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 Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug Subjected to any of the following within 4 weeks before administration of the study drug: Surgical treatment (operations,etc.). Plasma exchange method
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Kimura
Organizational Affiliation
Chugai Pharmaceutical Co., Ltd. Research Dept.1
Official's Role
Study Director
Facility Information:
Facility Name
Chugoku region
City
Chugoku
Country
Japan
Facility Name
Chukyo region
City
Chukyo
Country
Japan
Facility Name
Hokkaido region
City
Hokkaido
Country
Japan
Facility Name
Hokuriku region
City
Hokuriku
Country
Japan
Facility Name
Kansai region
City
Kansai
Country
Japan
Facility Name
Kanto region
City
Kanto
Country
Japan
Facility Name
Kousinetsu region
City
Kousinetsu
Country
Japan
Facility Name
Kyushu region
City
Kyushu
Country
Japan
Facility Name
Sikoku region
City
Sikoku
Country
Japan
Facility Name
Tohoku region
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

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