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The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.
The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | BG00012 480 mg/day |
|
| 2 | Active Comparator | BG00012 720 mg/day |
|
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00012 | Drug | oral |
| |
| BG00012 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is the proportion of subjects with ACR20 response in their RA at Week 12. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of BG00012 with methotrexate in this population. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other criteria also apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Woolloongabba | Queensland | 4102 | Australia | ||
| Research Site |
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| Drug |
Oral |
|
| placebo | Drug | oral placebo |
|
| Woodville |
| South Australia |
| 5011 |
| Australia |
| Research Site | Sarnia | Ontario | N7T4X3 | Canada |
| Research Site | New Market | Canada |
| Research Site | Ottawa | Canada |
| Research Site | Rothesay | Canada |
| Research Site | Active, Not Recruiting | Czechia |
| Research Site | Pardubice | Czechia |
| Research Site | Uh. Hradiste | Czechia |
| Research Site | Zlín | Czechia |
| Research Site | Bangalore | India |
| Research Site | Hyderabaad | India |
| Research Site | Hyderabad | India |
| Research Site | Lucknow | India |
| Research Site | Bialystock | Poland |
| Research Site | Grodzisk Mazowiecki | Poland |
| Research Site | Lublin | Poland |
| Research Site | Poznan | Poland |
| Research Site | Torun | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Banska Bysterica | Slovakia |
| Research Site | Bratislava | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Piešťany | Slovakia |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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