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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01256736

Enrollment

Registered

2010-12-09

Start date

2010-03-31

Completion date

2013-11-30

Last updated

2013-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGTocilizumab

intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks

DRUGDMARDs

DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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of CWP-TCZ301 * Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study * Patients who able to enroll in this study within 12 weeks after last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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026