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| ID | Type | Description | Link |
|---|---|---|---|
| B2271005 |
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This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ATN-103_30mg | Experimental |
| |
| Arm 2: ATN-103_80 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATN-103 | Drug | A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Ablynx NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35216 | United States | ||
| Investigational Site |
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| ATN-103 | Drug | A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study) |
|
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Investigational Site | Peoria | Arizona | 85381 | 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 | Ocala | Florida | 34474 | 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 | Lansing | Michigan | 48910 | United States |
| Investigational Site | Freehold | New Jersey | 07728 | United States |
| Investigational Site | Charlotte | North Carolina | 28210 | 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 | Tulsa | Oklahoma | 74104 | United States |
| Investigational Site | Lake Oswego | Oregon | 97035 | 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 | 75231 | United States |
| Investigational Site | San Antonio | Texas | 78217 | United States |
| Investigational Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Investigational Site | Kitchener | Ontario | N2M 5N6 | 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 | Budapest | 1023 | Hungary |
| Investigational Site | Budapest | 1036 | Hungary |
| Investigational Site | Debrecen | 4032 | Hungary |
| Investigational Site | Nitona-cho, Chuoh-ku, Chiba-shi | Chiba | Japan |
| Investigational Site | Bunkyoucho, Matsuyama | Ehime | Japan |
| Investigational Site | Chuoh-ku, Fukuoka-shi | Fukuoka | Japan |
| Investigational Site | Kurume | Fukuoka | Japan |
| Investigational Site | Yoshio-machi Iizuka-shi | Fukuoka | Japan |
| Investigational Site | Tohrimachi, Takasaki | Gunma | Japan |
| Investigational Site | Katō | Hyōgo | Japan |
| Investigational Site | Kumamoto | Kumamoto | Japan |
| Investigational Site | Honmachi, Higashiyama | Kyoto | Japan |
| Investigational Site | Miyazaki | Miyazaki | Japan |
| Investigational Site | Nagano | Nagano | Japan |
| Investigational Site | Yamato, Sasebo | Nagasaki | Japan |
| Investigational Site | Higashi-tyo, Kawachi Nagano | Osaka | Japan |
| Investigational Site | Ureshino-machi, Ureshino-shi | Saga-ken | Japan |
| Investigational Site | Kawagoe | Saitama | Japan |
| Investigational Site | Midori-cho 2 Chome Tokorozawa-shi | Saitama | Japan |
| Investigational Site | Kawada-cho, Shinjyuku-ku | Tokyo | Japan |
| Investigational Site | Shinanomachi, Shinjuku | Tokyo | Japan |
| Investigational Site | Takaoka-shi | Toyama | Japan |
| Investigational Site | Kemerovo | 650066 | Russia |
| Investigational Site | Moscow | 115522 | Russia |
| Investigational Site | Novosibirsk | 630008 | Russia |
| Investigational Site | Orenburg | 460018 | 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 | Les Marais | Gauteng | 0084 | South Africa |
| Investigational Site | Berea | KwaZulu-Natal | 4001 | South Africa |
| Investigational Site | Panorama | Western Cape | 7500 | South Africa |
| Investigational Site | Pinelands | Western Cape | 7405 | South Africa |
| Investigational Site | Chur | 7000 | Switzerland |
| 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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