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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211834

Enrollment

Registered

2010-09-30

Start date

2009-10-31

Completion date

2010-10-31

Last updated

2010-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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

Interventions

DRUGtocilizumab

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

DRUGDMARDs

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

DRUGPlacebo

intravenously over 1 hour infusion every 4weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with ACR20 responses	24weeks	Proportion of patients with ACR20 responses at post therapy

Secondary

Measure	Time frame
Proportion of patients with ACR50 and ACR70 responses at post therapy	24weeks
Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin	24weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026