Skip to main content
OpenTrials
Completed

NCT Number: NCT01256736

To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.

Completed

Looking for future studies?

Notify Me

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

  • Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
  • Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
  • Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
  • Willing to give written informed consent

Exclusion criteria

  • History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
  • ALT or AST > ULNⅹ2.5
  • Platelet count < 100ⅹ103/ μL
  • WBC < 3,000/mm3
  • Absolute neutrophil count < 1,000/mm3
  • Absolute lymphocyte count < 500/mm3
  • Total bilirubin > ULNⅹ2

Treatment and study plan

Tocilizumab

Drug

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

DMARDs

Drug

DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Primary outcomes

  1. Safety results

    Time frame: 48weeks

    • All AE/ADR during study
    • Physical examination including vital signs and ECG
    • Clinical laboratory results

Secondary outcomes

  1. Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy

    Time frame: 48weeks

  2. Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy

    Time frame: 48weeks

  3. Change of individual parameter in ACR core set

    Time frame: 48weeks

  4. Change of individual parameter in DAS28

    Time frame: 48weeks

  5. Change of individual parameter in Rheumatoid factor

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Nov 20, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.