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| ID | Type | Description | Link |
|---|---|---|---|
| B2271004 |
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This primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously (below the skin) to Japanese subjects with active rheumatoid arthritis and on a stable background of methotrexate. Some subjects will receive ATN-103 while other subjects will receive a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Cohort 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATN-103 10 mg q4wks | Biological | ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be evaluated on the basis of AEs, SAEs,(including injection site reactions and infections), physical examination findings, vital sign, measurements, immunogenicity assessments, early termination, and clinical laboratory test. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy for Rheumatoid Arthritis (RA) based on ACR responses, ACR-N, DAS 28 and EULAR response. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Any cytotoxic drugs. Leflunomide. Any investigational biological drug(s).
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| Name | Affiliation | Role |
|---|---|---|
| Josefin-Beate Holz | Ablynx, a Sanofi company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Chiba | Japan | ||||
| Investigational Site |
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| ATN-103 30 mg q4wks | Biological | ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.3 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections. |
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| ATN-103 80 mg q4wks | Biological | ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 4-week intervals for a total of 4 SC injections. |
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| ATN-103 10 mg q8wks | Biological | ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.1 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections. |
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| ATN-103 80 mg q8wks | Biological | ATN-103 160-mg vials (lyophilized) and placebo vials (lyophilized) Each subject will be given a single SC injection (0.8 mL) of either ATN-103 or placebo at 8-week intervals for a total of 2 SC injections. |
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| Ehime |
| Japan |
| Investigational Site | Fukuoka | Japan |
| Investigational Site | Gunma | Japan |
| Investigational Site | Hyōgo | Japan |
| Investigational Site | Kumamoto | Japan |
| Investigational Site | Kyoto | Japan |
| Investigational Site | Miyazaki | Japan |
| Investigational Site | Nagano | Japan |
| Investigational Site | Nagasaki | Japan |
| Investigational Site | Osaka | Japan |
| Investigational Site | Saga | Japan |
| Investigational Site | Saitama | Japan |
| Investigational Site | Tokyo | Japan |
| Investigational Site | Toyama | Japan |
| 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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