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OpenTrials
Completed

NCT Number: NCT01211834

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National Univ. Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

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

DMARDs

Drug

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

Placebo

Drug

intravenously over 1 hour infusion every 4weeks

Primary outcomes

  1. Proportion of patients with ACR20 responses

    Time frame: 24weeks

    Proportion of patients with ACR20 responses at post therapy

Secondary outcomes

  1. Proportion of patients with ACR50 and ACR70 responses at post therapy

    Time frame: 24weeks

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

    Time frame: 24weeks

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 30, 2010
Registry last updated
Nov 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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