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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256736
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : November 20, 2013
Information provided by (Responsible Party):
JW Pharmaceutical

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Tocilizumab Drug: DMARDs Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab
U.S. FDA Resources

Arm Intervention/treatment
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)

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256736

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

Responsible Party: JW Pharmaceutical Identifier: NCT01256736     History of Changes
Other Study ID Numbers: CWP-TCZ302
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases