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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00380601
First received: September 25, 2006
Last updated: December 22, 2009
Last verified: December 2009
History of Changes

September 25, 2006
December 22, 2009
May 2006
August 2008   (final data collection date for primary outcome measure)
Frequency of ACR 20％ improvement at the final visit [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Frequency of ACR 20％ improvement at the final visit
  • Efficacy:
  • Safety:
  • Frequecy and severe of adverse events and adverse drug reactions
Complete list of historical versions of study NCT00380601 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Time course of DAS28 to the final visit. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Time course of steroid sparing effect from first visit to final visit. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • 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.
 
 
 
PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)
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
 
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: MRA(Tocilizumab)
8mg/kg/4 weeks
Experimental: 1
Intervention: Drug: MRA(Tocilizumab)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00380601
MRA225JP
 
Chugai Pharmaceutical Co.,Ltd.
Chugai Pharmaceutical
 
Study Director: Yuji Kimura Chugai Pharmaceutical Co., Ltd. Research Dept.1
Chugai Pharmaceutical
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP