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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00482989 | A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus | PHASE1 | COMPLETED | 183 | — | — | Jun 1, 2007 | Sep 1, 2010 | Jul 11, 2012 | 23 | United States, Argentina +2 |
| NCT00299819 | Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE) | PHASE1 | COMPLETED | 45 | — | — | Mar 1, 2006 | Oct 1, 2007 | Dec 18, 2007 | 21 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MEDI-545 |
| 2 | OTHER | Placebo |
| 3 | ACTIVE_COMPARATOR | MEDI-545 |
| 4 | ACTIVE_COMPARATOR | MEDI-545 |
| 5 | ACTIVE_COMPARATOR | MEDI-545 |
| Name | Type | Description |
|---|---|---|
| MEDI 545 | BIOLOGICAL | MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial. Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks. |
| Placebo | OTHER | Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial. Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks. |
| MEDI-545 | BIOLOGICAL | 0.3 mg/kg IV (n=6) at Study Day 0 |
Inclusion Criteria: * Male or female adults ≥ 18 years of age at the time of the first dose of study drug; * Written informed consent obtained from the patient; or patient's legal representative; * Meet at least 4 of the 11 revised ACR classification criteria for SLE (see Appendix A) (ACR,1999); * ...