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

Phase 3 Completed 89 enrolled JW Pharmaceutical

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2010-03
Primary completion: 2011-12
Completion: 2013-11

Publications

Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous
Background	Azathioprine	Small molecule	—	—
Background	Chloroquine	Small molecule	—	—
Background	Hydroxychloroquine	Small molecule	—	—
Background	Leflunomide	Small molecule	—	—
Background	Sulfasalazine	Small molecule	—	—

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

Summary

Timeline

Publications

Drugs

Indications