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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00206674 | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | PHASE3 | COMPLETED | 286 | — | — | Sep 1, 2004 | Jun 1, 2006 | Dec 4, 2013 | 70 | Argentina, Australia +7 |
| NCT00206596 | Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease | PHASE2 | COMPLETED | 127 | — | — | Jul 1, 2003 | Oct 1, 2005 | Dec 4, 2013 | - | — |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sargramostim (Leukine) | DRUG | 6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks |
| Placebo | DRUG | Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks |
Inclusion Criteria: * Stable but active Crohn's disease at the time of screening * Must be able to self-inject or have another person who can help with the injection Exclusion Criteria: * Not have a colostomy or ileostomy * Not be taking prohibited medications as defined in the protocol * Not hav...