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

JW Pharmaceutical1 site in 1 country89 target enrollmentMarch 2010

ConditionsRheumatoid Arthritis

InterventionsTocilizumab DMARDs

DrugsTocilizumab DMARDs

Overview

Phase: Phase 3
Intervention: Tocilizumab
Conditions: Rheumatoid Arthritis
Sponsor: JW Pharmaceutical
Enrollment: 89
Locations: 1
Primary Endpoint: Safety results
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

November 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

JW Pharmaceutical

Responsible Party

Sponsor

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•Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study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

Arms & Interventions

Tocilizumab 8mg/kg + DMARDs

Intervention: Tocilizumab

Tocilizumab 8mg/kg + DMARDs

Intervention: DMARDs

Outcomes

Primary Outcomes

Safety results

Time Frame: 48weeks

1. All AE/ADR during study 2. Physical examination including vital signs and ECG 3. Clinical laboratory results

Secondary Outcomes

Change of individual parameter in Rheumatoid factor(48 weeks)
Change of individual parameter in ACR core set(48weeks)
Change of individual parameter in DAS28(48weeks)
Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy(48weeks)
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy(48weeks)