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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tocilizumab; Drug: DMARDs

• Registration Number: NCT01256736
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-09
• Primary Completion: 2011-12
• Status Verified: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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• Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tocilizumab 8mg/kg + DMARDs	Tocilizumab	-
Tocilizumab 8mg/kg + DMARDs	DMARDs	-

Primary Outcome Measures

Name	Time	Method
Safety results	48weeks	1. All AE/ADR during study; 2. Physical examination including vital signs and ECG; 3. Clinical laboratory results

Secondary Outcome Measures

Name	Time	Method
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
Change of individual parameter in ACR core set	48weeks
Change of individual parameter in DAS28	48weeks
Change of individual parameter in Rheumatoid factor	48 weeks

Trial Locations

Locations (1)

Seoul National Univ. Hospital; 🇰🇷 Seoul, Korea, Republic of