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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00069017 | Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate | PHASE2 | COMPLETED | 300 | — | — | Sep 1, 2003 | Apr 1, 2006 | Nov 27, 2007 | 40 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | MEDI-522 - 4 mg/kg of MEDI-522 (N=200) |
| 2 | PLACEBO_COMPARATOR | Placebo (N=100) |
| Name | Type | Description |
|---|---|---|
| MEDI-522 | BIOLOGICAL | MEDI-522 is formulated in a sterile isotonic solution of 10 mM histidine-HCl at pH 6 containing 100 mg of MEDI-522 protein at a concentration of 100 mg/mL. |
| Placebo | OTHER | Placebo for MEDI-522 contains 10 mM histidine-HCl at pH 6, 0.1% Tween-80, 1.5% Mannitol, 4.3 µg/mL Vitamin B12, and 2 µg/mL D\&C Yellow #10. |
Patients must meet all of the following criteria: 1. Age greater than or equal to 18 (reached 18th birthday or later) at the time of the first dose of study drug 2. Written informed consent obtained from the patient 3. Sexually active females, unless surgically sterile or at least one year post-men...