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

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

Detailed Description
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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).

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: LBEC0101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBEC0101<br>Etanercept 50mg | Drug: LBEC0101<br>* Etanercept 50mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28-ESR | Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100 | 48 weeks | 

Secondary Outcome Measures

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