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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00771420 | A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis | PHASE1 | COMPLETED | 38 | — | — | Oct 1, 2008 | Feb 1, 2009 | Jul 20, 2012 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | 0.01mg/kg and 0.03mg/kg CAM-3001 |
| 2 | ACTIVE_COMPARATOR | 0.1mg/kg CAM-3001 |
| 3 | ACTIVE_COMPARATOR | 0.3mg/kg CAM-3001 |
| 4 | ACTIVE_COMPARATOR | 1.0mg/kg CAM-3001 |
| 5 | ACTIVE_COMPARATOR | 3.0mg/kgCAM-3001 |
| 6 | ACTIVE_COMPARATOR | 10.0mg/kg CAM-3001 |
| 7 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| CAM-3001 | DRUG | A single patient shall be dosed with a dose of 0.01mg/kg of CAM-3001 followed no sooner than 24 hours later by a second patient at a dose of 0.03mg/kg. |
| Placebo | OTHER | Active: Placebo 5:1 for arms 2-6 |
Inclusion Criteria: * Signed and dated informed consent, prior to any study related procedures * Male and female patients aged 18-70 years at the screening visit * Use of an appropriate method of contraception * A diagnosis of adult onset rheumatoid arthritis of at least 6 months duration as define...