NCT01211834CompletedPhase 3
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy
JW Pharmaceutical1 site in 1 country90 target enrollmentStarted: October 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Proportion of patients with ACR20 responses
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tocilizumab 8mg/kg+DMARDs
Experimental
Intervention: tocilizumab (Drug)
Tocilizumab 8mg/kg+DMARDs
Experimental
Intervention: DMARDs (Drug)
Placebo+DMARDs
Placebo Comparator
Intervention: Placebo (Drug)
Placebo+DMARDs
Placebo Comparator
Intervention: DMARDs (Drug)
Outcomes
Primary Outcomes
Proportion of patients with ACR20 responses
Time Frame: 24weeks
Proportion of patients with ACR20 responses at post therapy
Secondary Outcomes
- Proportion of patients with ACR50 and ACR70 responses at post therapy(24weeks)
- Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin(24weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT00531817Hoffmann-La Roche619
Completed
Phase 3
A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)Polymyalgia RheumaticaNCT03263715Medical University of Vienna39
Completed
Phase 3
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 PneumoniaCOVID-19 PneumoniaNCT04320615Hoffmann-La Roche452
Completed
Phase 3
A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)Systemic SclerosisNCT02453256Hoffmann-La Roche212
Completed
Phase 3
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 PneumoniaCOVID-19 PneumoniaNCT04372186Genentech, Inc.377