Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01007175 | Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 60 | — | — | Nov 1, 2009 | Sep 1, 2010 | Sep 4, 2013 | 15 | Japan |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Inclusion Criteria: * Meets the ACR 1987 revised criteria for classification of Rheumatoid Arthritis (RA). * ACR functional class I through III. * Active RA at the time of screening and at baseline consisting of = 6 swollen and = 6 tender joints at least. * hs-CRP level = 8 mg/L. * Must be receivin...