Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT01211834
- Lead Sponsor
- JW Pharmaceutical
- 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 moderate to severe active RA and inadequate response to current DMARD treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tocilizumab 8mg/kg+DMARDs DMARDs - Placebo+DMARDs Placebo - Placebo+DMARDs DMARDs - Tocilizumab 8mg/kg+DMARDs tocilizumab -
- Primary Outcome Measures
Name Time Method Proportion of patients with ACR20 responses 24weeks Proportion of patients with ACR20 responses at post therapy
- Secondary Outcome Measures
Name Time Method Proportion of patients with ACR50 and ACR70 responses at post therapy 24weeks Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin 24weeks
Trial Locations
- Locations (1)
Seoul National Univ. Hospital
🇰🇷Seoul, Korea, Republic of