A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Patients who completed the treatment period of Study LG-ECCL002

• Patients requiring continuous treatment for rheumatoid arthritis upon the investigator's discretion

• For childbearing female patients or surgically non-sterile male patients, those who agreed to avoid pregnancy using proper contraceptive methods during the study.

• Patients who made a voluntary decision to participate in this clinical study and gave a voluntary written consent to comply with all the instructions with full understanding after being informed of the study

Exclusion Criteria:

• Patients deemed difficult to participate in this extension study due to the adverse events which occurred in Study LG-ECCL002, upon the investigator's discretion at screening

• Patients with at least 10 swollen joints (out of the total 66 assessing joints) or at least 12 tender joints (out of the total 68 assessing joints) at screening

• Women in pregnancy or lactation, or patients planning to be pregnant during the study period

• Patients ineligible for this clinical study upon the investigator's discretion