Brief Summary

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Official Title: "An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA"

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

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: August 2008

Interventions Used in this Clinical Trial

• Drug: MRA(Tocilizumab)
  • 8mg/kg/4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

• Frequency of ACR 20％ improvement at the final visit
  • Time Frame: throughout study
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• Time course of DAS28 to the final visit.
  • Time Frame: throughout study
    Safety Issue?: No
• Time course of steroid sparing effect from first visit to final visit.
  • Time Frame: throughout study
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Chugai Pharmaceutical
• Provider of Information About this Clinical Study
  • Chugai Pharmaceutical Co.,Ltd., Chugai Pharmaceutical Co.,Ltd.
• Overall Official(s)
  • Yuji Kimura, Study Director, Chugai Pharmaceutical Co., Ltd. Research Dept.1