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

JW Pharmaceutical90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

tocilizumabDRUG

intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks

DMARDsDRUG

Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

PlaceboDRUG

intravenously over 1 hour infusion every 4weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National Univ. Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of patients with ACR20 responses

Proportion of patients with ACR20 responses at post therapy

Time frame: 24weeks

Secondary Outcomes

Proportion of patients with ACR50 and ACR70 responses at post therapy

Time frame: 24weeks

Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin

Time frame: 24weeks

Data from ClinicalTrials.gov

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