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

Chugai Pharmaceutical10 sites in 1 country20 target enrollmentMay 2006

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

February 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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

•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

Intervention: MRA(Tocilizumab)

Frequency of ACR 20％ improvement at the final visit

Time Frame: throughout study

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