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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01008852 | Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis | PHASE2 | COMPLETED | 210 | — | — | Dec 1, 2009 | Jul 1, 2013 | Dec 3, 2013 | 55 | United States, Argentina +8 |
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | - |
| Treatment Group 2 | EXPERIMENTAL | - |
| Treatment Group 3 | EXPERIMENTAL | - |
| Treatment Group 4 | EXPERIMENTAL | - |
| Treatment Group 5 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SBI-087 | DRUG | 200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate |
| Placebo | DRUG | Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate |
Inclusion Criteria: * Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening * Active RA as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: C-r...