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

LG Life Sciences

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: LBEC0101

Study type

Interventional

Funder types

Industry

Identifiers

NCT02715908

LG-ECCL004

Details and patient eligibility

About

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

Full description

this study is to evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX for additional 48 weeks (a total of 100 weeks including 52 weeks of the treatment period in Study LG-ECCL002) in the subjects who have completed the treatment period of phase III clinical study for LBEC0101 (Study No. LG-ECCL002).

Enrollment

148 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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