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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02715908
• Date of registration: 17/03/2016
• Prospective Registration: Yes
• Primary sponsor: LG Life Sciences
• Public title: A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)
• Scientific title: A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002
• Date of first enrolment: April 2016
• Target sample size: 148
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02715908
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: LBEC0101

Primary Outcome(s)

DAS28-ESR [Time Frame: 48 weeks]

Secondary Outcome(s)

ACR 20, 50, 70 [Time Frame: 48 weeks]

EULAR response [Time Frame: 48 weeks]

Remission rate [Time Frame: 48 weeks]

DAS28-CRP [Time Frame: 48 weeks]

Secondary ID(s)

LG-ECCL004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors