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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBEC0101 | Experimental | Etanercept 50mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBEC0101 | Drug | Etanercept 50mg |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31113455 | Derived | Park MC, Matsuno H, Kim J, Park SH, Lee SH, Park YB, Lee YJ, Lee SI, Park W, Sheen DH, Choe JY, Choi CB, Hong SJ, Suh CH, Lee SS, Cha HS, Yoo B, Hur JW, Kim GT, Yoo WH, Baek HJ, Shin K, Shim SC, Yang HI, Kim HA, Park KS, Choi IA, Lee J, Tomomitsu M, Shin S, Lee J, Song YW. Long-term efficacy, safety and immunogenicity in patients with rheumatoid arthritis continuing on an etanercept biosimilar (LBEC0101) or switching from reference etanercept to LBEC0101: an open-label extension of a phase III multicentre, randomised, double-blind, parallel-group study. Arthritis Res Ther. 2019 May 21;21(1):122. doi: 10.1186/s13075-019-1910-2. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000626868 | LBEC0101 |
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| 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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |