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

JW Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: DMARDs; Drug: Tocilizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01256736

CWP-TCZ302

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Tocilizumab 8mg/kg + DMARDs

Experimental group

Treatment:

Drug: Tocilizumab

Drug: DMARDs