Status:
COMPLETED
PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00380601
Start Date
May 1 2006
End Date
February 1 2009
Last Update
December 23 2009
Active Locations (10)
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1
Chugoku region
Chugoku, Japan
2
Chukyo region
Chukyo, Japan
3
Hokkaido region
Hokkaido, Japan
4
Hokuriku region
Hokuriku, Japan