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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256736
• Other study ID #: CWP-TCZ302
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2010
• Last updated: November 18, 2013
• Start date: March 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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• Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study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 > ULN?2.5

• Platelet count < 100?103/ µL

• WBC < 3,000/mm3

• Absolute neutrophil count < 1,000/mm3

• Absolute lymphocyte count < 500/mm3

• Total bilirubin > ULN?2

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tocilizumab
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
• DMARDs
DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety results	All AE/ADR during study; Physical examination including vital signs and ECG; Clinical laboratory results	48weeks	Yes
Secondary	Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy		48weeks	No
Secondary	Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy		48weeks	No
Secondary	Change of individual parameter in ACR core set		48weeks	No
Secondary	Change of individual parameter in DAS28		48weeks	No
Secondary	Change of individual parameter in Rheumatoid factor		48 weeks	No