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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00639834 | Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis | PHASE1 | COMPLETED | 26 | — | — | Feb 1, 2008 | Jun 1, 2010 | May 22, 2013 | 24 | United States, Germany +3 |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Active MDX-1342 given in combination with Methotrexate |
| Name | Type | Description |
|---|---|---|
| MDX-1342 | BIOLOGICAL | One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment. |
Inclusion Criteria: * Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA) * Must have active RA * Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug adminis...