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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00928681 | A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis | PHASE1 | COMPLETED | 80 | — | — | Sep 1, 2005 | Oct 1, 2008 | Jun 26, 2009 | 18 | Belgium, Czechia +5 |
| Arm | Type | Description |
|---|---|---|
| 0.03 mg/kg or placebo iv | OTHER | - |
| 0.1 mg/kg or placebo iv | OTHER | - |
| 0.3 mg/kg or placebo iv | OTHER | - |
| 1.0 mg/kg or placebo iv | EXPERIMENTAL | - |
| 3.0 mg/kg or placebo sc | OTHER | - |
| 10 mg/kg or placebo iv | OTHER | - |
| 0.3 mg/kg or placebo sc | OTHER | - |
| 0.1 mg/kg or placebo iv (multiple dose) | OTHER | - |
| 0.3 mg/kg or placebo iv (multiple dose) | OTHER | - |
| 3.0 mg/kg or placebo iv | OTHER | - |
| 0.1 mg/kg or placebo sc | OTHER | - |
| 0.3 mg/kg or placebo sc (multiple dose) | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Single dose-group A | BIOLOGICAL | PF-00547659, single iv dose |
| Multiple dose- Group B | BIOLOGICAL | PF-00547659, multiple dose |
| Multiple dose-Group B | BIOLOGICAL | PF-00547659, multiple dose |
Inclusion Criteria: * A positive histological diagnosis of UC ≥3 months prior to entry into the study. If a histological diagnosis is not available but all signs and symptoms suggest UC, the subject's eligibility should be discussed with Pfizer. * Active UC as defined by a score of ≥6 on the Mayo s...