Status:
COMPLETED
Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Lead Sponsor:
JW Pharmaceutical
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with m...
Eligibility Criteria
Inclusion
- adult patients, \>= 18 years of age
- Active RA of \> 6monts duration
- Received permitted DMARDs each at a stable dose for at least 8 weeks
Exclusion
- Rheumatic autoimmune disease other than RA
- Significant systemic involvement secondary to RA
- ALT or AST \> ULNⅹ1.5
- Platelet count \< 100,000/mm3
- Hemoglobin \< 8.5 g/dL
- White blood cells \< 3,000/mm3
- Absolute neutrophil count \< 2,000/mm3
- Absolute lymphocyte count \< 500/mm3
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01211834
Start Date
October 1 2009
End Date
October 1 2010
Last Update
November 3 2010
Active Locations (1)
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1
Seoul National Univ. Hospital
Seoul, South Korea, 110-744