Rheumatoid Arthritis
Conditions
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).
Interventions
DRUGLBEC0101
Etanercept 50mg
Sponsors
LG Life Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DAS28-ESR | 48 weeks | Mean change in DAS28-ESR score from baseline (Weeks 0 and 52) at Weeks 76 and 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed