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| ID | Type | Description | Link |
|---|---|---|---|
| B2271003 |
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The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | ATN-103 10 mg every 4 weeks until week 12 |
|
| Treatment Group 2 | Experimental | ATN-103 10 mg every 8 weeks until week 12 |
|
| Treatment Group 3 | Experimental | ATN-103 30 mg every 4 weeks until week 12 |
|
| Treatment Group 4 | Experimental | ATN-103 80 mg every 4 weeks until week 12 |
|
| Treatment Group 5 | Experimental | ATN-103 80 mg every 8 weeks until week 12 |
|
| Treatment Group 6 | Placebo Comparator | Placebo every 4 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATN-103 | Drug | 10 mg every 4 weeks until week 12 |
| |
| ATN-103 |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology (ACR) 20 response at week 16 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josefin-Beate Holz, MD | Ablynx, a Sanofi company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| Investigational Site |
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|
| Drug |
10 mg every 8 weeks until week 12 |
|
| ATN-103 | Drug | 30 mg every 4 weeks until week 12 |
|
| ATN-103 | Drug | 80 mg every 4 weeks until week 12 |
|
| ATN-103 | Drug | 80 mg every 8 weeks until week 12 |
|
| Placebo | Drug | Placebo every 4 weeks |
|
| Methotrexate | Drug |
|
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Investigational Site | Peoria | Arizona | 85381 | United States |
| Investigational Site | Scottsdale | Arizona | 85258 | United States |
| Investigational Site | Riverside | California | 92501 | United States |
| Investigational Site | Upland | California | 91786 | United States |
| Investigational Site | Bridgeport | Connecticut | 06606 | United States |
| Investigational Site | Newark | Delaware | 19713 | United States |
| Investigational Site | Lake Mary | Florida | 32746 | United States |
| Investigational Site | Ocala | Florida | 34474 | United States |
| Investigational Site | Orlando | Florida | 32804 | United States |
| Investigational Site | Port Orange | Florida | 32127 | United States |
| Investigational Site | Vero Beach | Florida | 32960 | United States |
| Investigational Site | Coeur d'Alene | Idaho | 83814 | United States |
| Investigational Site | Frederick | Maryland | 21702 | United States |
| Investigational Site | West Yarmouth | Massachusetts | 12672 | United States |
| Investigational Site | Lansing | Michigan | 48910 | United States |
| Investigational Site | Freehold | New Jersey | 07728 | United States |
| Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| Investigational Site | Mineola | New York | 11501 | United States |
| Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Investigational Site | Hickory | North Carolina | 28601 | United States |
| Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| Investigational Site | Columbus | Ohio | 43213 | United States |
| Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Investigational Site | Oklahoma City | Oklahoma | 73139 | United States |
| Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Investigational Site | Lake Oswego | Oregon | 97035 | United States |
| Investigational Site | Allentown | Pennsylvania | 18103 | United States |
| Investigational Site | Columbia | South Carolina | 29204 | United States |
| Investigational Site | Myrtle Beach | South Carolina | 29572 | United States |
| Investigational Site | Nashville | Tennessee | 37205 | United States |
| Investigational Site | Dallas | Texas | 75235 | United States |
| Investigational Site | Houston | Texas | 77004 | United States |
| Investigational Site | San Antonio | Texas | 78217 | United States |
| Investigational Site | Tacoma | Washington | 98405 | United States |
| Investigational Site | Brussels | Belgium | 1200 | Belgium |
| Investigational Site | Leuven | 3000 | Belgium |
| Investigational Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Investigational Site | Kitchener | Ontario | N2M 5N6 | Canada |
| Investigational Site | Ottawa | Ontario | K1H 1A2 | Canada |
| Investigational Site | St. Catharines | Ontario | L2N 7E4 | Canada |
| Investigational Site | Toronto | Ontario | M9L 3A2 | Canada |
| Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| Investigational Site | Vogelsang | Gommern | 39245 | Germany |
| Investigational Site | Budapest | 1027 | Hungary |
| Investigational Site | Debrecen | 4012 | Hungary |
| Investigational Site | Kemerovo | 650061 | Russia |
| Investigational Site | Moscow | 113811 | Russia |
| Investigational Site | Moscow | 119049 | Russia |
| Investigational Site | Novosibirsk | 630047 | Russia |
| Investigational Site | Novosibirsk | 630091 | Russia |
| Investigational Site | Orenburg | 460000 | Russia |
| Investigational Site | Petrozavodsk | 185019 | Russia |
| Investigational Site | Ryazan | 390026 | Russia |
| Investigational Site | Vladimir | 600023 | Russia |
| Investigational Site | Yaroslavl | 150003 | Russia |
| Investigational Site | Yaroslavl | 150062 | Russia |
| Investigational Site | Belgrade | Serbia | 11000 | Serbia |
| Investigational Site | Niška Banja | 18205 | Serbia |
| Investigational Site | Berea | KwaZulu-Natal | 4001 | South Africa |
| Investigational Site | Cape Town | 7405 | South Africa |
| Investigational Site | Cape Town | 7500 | South Africa |
| Investigational Site | Pretoria | 0181 | South Africa |
| Investigational Site | Zurich | Canton of Zurich | 8091 | Switzerland |
| Investigational Site | Chur | 7000 | Switzerland |
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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