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| ID | Type | Description | Link |
|---|---|---|---|
| WA17043 |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
| |
| 6 | Experimental |
| |
| 7 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | Oral or parenteral repeating dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an ACR20 response | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with ACR(50,70) responses | 24 weeks | |
| Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups | 24 weeks |
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Eligibility criteria include, but are not limited to the following:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18050221 | Derived | Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908. doi: 10.1002/art.23059. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 20, 2017 | |
| Reset | Jul 19, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 20, 2017 | Jul 19, 2017 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000069283 | Rituximab |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| 8 | Placebo Comparator |
|
| 9 | Placebo Comparator |
|
| rituximab | Drug | Intravenous repeating dose |
|
| corticosteroids | Drug | Intravenous repeating dose |
|
| placebo | Drug | Intravenous repeating dose |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |