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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00959036 | Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis | PHASE1 | COMPLETED | 252 | — | — | Sep 1, 2009 | Jan 1, 2011 | Jan 30, 2013 | 67 | United States, Belgium +7 |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| ATN-103 | DRUG | 10 mg every 4 weeks until week 12 |
| Placebo | DRUG | Placebo every 4 weeks |
| Methotrexate | DRUG | - |
Inclusion Criteria: * Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly). Exclusion Criteria: * Any significant health problem other than rheumatoid arthritis * Any clinically significant laboratory abnormalities * Any prior use of B cell-d...