Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

JW Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: DMARDs; Drug: tocilizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211834

CWP-TCZ301

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Tocilizumab 8mg/kg+DMARDs

Experimental group

Treatment:

Drug: DMARDs

Drug: DMARDs

Drug: tocilizumab

Placebo+DMARDs

Placebo Comparator group

Treatment:

Drug: DMARDs

Drug: Placebo

Drug: DMARDs