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| Name | Class |
|---|---|
| Mochida Pharmaceutical Company, Ltd. | INDUSTRY |
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBAL | Experimental | Adalimumab |
|
| Humira® | Active Comparator | Adalimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBAL | Drug | Adalimumab |
| |
| Humira® |
| Measure | Description | Time Frame |
|---|---|---|
| DAS28-ESR | DAS is a combined index to measure the disease activity in patients with Rheumatoid Arthritis (RA). DAS28-ESR is calculated by assessing the number of swollen and tender joints (among 28 joints) and measuring the ESR. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mochida Investigational site | Tokyo | Japan | ||||
| LGLS Investigational site |
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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 |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Adalimumab |
|
| Seoul |
| South Korea |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |