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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01011959 | A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects | PHASE1 | COMPLETED | 60 | — | — | Dec 1, 2008 | Aug 1, 2009 | Sep 30, 2013 | 24 | United States |
| NCT01026519 | A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 32 | — | — | Sep 1, 2008 | May 1, 2009 | Sep 30, 2013 | 1 | Russia |
| NCT01055899 | Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis | PHASE1 | COMPLETED | 15 | — | — | Jul 1, 2008 | Mar 1, 2009 | Sep 30, 2013 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | dose 1 vs. placebo |
| 2 | ACTIVE_COMPARATOR | dose 2 vs. placebo |
| 3 | ACTIVE_COMPARATOR | dose 3 vs. placebo |
| 4 | ACTIVE_COMPARATOR | dose 4 vs. placebo |
| 5 | ACTIVE_COMPARATOR | dose 5 vs. placebo |
| 6 | ACTIVE_COMPARATOR | dose 6 vs. placebo |
| Dose 1 | EXPERIMENTAL | Active dose |
| Dose 2 | EXPERIMENTAL | Active dose |
| Dose 3 | EXPERIMENTAL | Active 3 |
| Dose 4 | PLACEBO_COMPARATOR | Placebo dose |
| Name | Type | Description |
|---|---|---|
| REGN88 | BIOLOGICAL | This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete. |
| Placebo | OTHER | Placebo to match REGN88 administration |
Inclusion Criteria: * Patients with an established diagnosis of Rheumatoid Arthritis * Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks Exclusion Criteria: * Persistent chronic or current active infections * Patients who have ...