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

This study has been completed.
Information provided by (Responsible Party):
JW Pharmaceutical Identifier:
First received: October 28, 2010
Last updated: November 18, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tocilizumab
Drug: DMARDs
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Safety results [ Time Frame: 48weeks ] [ Designated as safety issue: Yes ]
    1. All AE/ADR during study
    2. Physical examination including vital signs and ECG
    3. Clinical laboratory results

Secondary Outcome Measures:
  • Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy [ Time Frame: 48weeks ] [ Designated as safety issue: No ]
  • Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy [ Time Frame: 48weeks ] [ Designated as safety issue: No ]
  • Change of individual parameter in ACR core set [ Time Frame: 48weeks ] [ Designated as safety issue: No ]
  • Change of individual parameter in DAS28 [ Time Frame: 48weeks ] [ Designated as safety issue: No ]
  • Change of individual parameter in Rheumatoid factor [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: March 2010
Study Completion Date: November 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tocilizumab 8mg/kg + DMARDs Drug: Tocilizumab
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
Drug: DMARDs
DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01256736

Korea, Republic of
Seoul National Univ. Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
JW Pharmaceutical
  More Information

No publications provided

Responsible Party: JW Pharmaceutical Identifier: NCT01256736     History of Changes
Other Study ID Numbers: CWP-TCZ302
Study First Received: October 28, 2010
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014