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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: LBEC0101

• Registration Number: NCT02715908
• Lead Sponsor: LG Life Sciences

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-22
• Study Start: 2016-04
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LBEC0101	LBEC0101	Etanercept 50mg

Primary Outcome Measures

Name	Time	Method
DAS28-ESR	48 weeks	Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100

Secondary Outcome Measures

Name	Time	Method
DAS28-CRP	48 weeks	Mean change in DAS28-CRP score from baseline (Weeks 0 and 52) at Weeks 76 and 100
ACR 20, 50, 70	48 weeks	Response rate on ACR20, 50, 70 at Weeks 52, 76, and 100 based on baseline (Week 0)
Remission rate	48 weeks	Remission rate (i.e., DAS28-ESR \<2.6) at Weeks 52, 76, and 100
EULAR response	48 weeks	Rate of EULAR response on DAS28-ESR at Weeks 52, 76, and 100

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of