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The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NI-071 | Experimental |
| |
| Remicade | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | 100mg/vial |
| |
| Infliximab |
| Measure | Description | Time Frame |
|---|---|---|
| Safety : Incidence of Adverse Events | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PK : Area under the serum concentration versus time curve(AUC) | 14 weeks | |
| Efficacy : ACR core-set | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
History of following diseases
Patients with active or latent tuberculosis or history of tuberculosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 392001001 | Sendai | Miyagi | 982-0032 | Japan |
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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 |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Biological |
100mg/vial |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |