NCT02715908CompletedPhase 3
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
LG Life Sciences1 site in 1 country148 target enrollmentStarted: April 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- DAS28-ESR
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LBEC0101
Experimental
Etanercept 50mg
Intervention: LBEC0101 (Drug)
Outcomes
Primary Outcomes
DAS28-ESR
Time Frame: 48 weeks
Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100
Secondary Outcomes
- DAS28-CRP(48 weeks)
- ACR 20, 50, 70(48 weeks)
- Remission rate(48 weeks)
- EULAR response(48 weeks)
Investigators
Study Sites (1)
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