To evaluate the long-term safety including immunogenicity and efficacy of LBEC0101 50 mg subcutaneous weekly injection when co-administered with MTX
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Etanercept 50mg
Seoul National University Hospital
Seoul, South Korea
DAS28-ESR
Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100
Time frame: 48 weeks
DAS28-CRP
Mean change in DAS28-CRP score from baseline (Weeks 0 and 52) at Weeks 76 and 100
Time frame: 48 weeks
ACR 20, 50, 70
Response rate on ACR20, 50, 70 at Weeks 52, 76, and 100 based on baseline (Week 0)
Time frame: 48 weeks
Remission rate
Remission rate (i.e., DAS28-ESR \<2.6) at Weeks 52, 76, and 100
Time frame: 48 weeks
EULAR response
Rate of EULAR response on DAS28-ESR at Weeks 52, 76, and 100
Time frame: 48 weeks
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