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.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01256736
First received: October 28, 2010
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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)

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256736

Locations
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
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014