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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02277574 | Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 29 | — | — | Jun 1, 2014 | Jul 1, 2015 | Nov 21, 2016 | 7 | United States |
| NCT01878123 | Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2013 | Jul 1, 2014 | Sep 30, 2016 | 3 | United States |
Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations
Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life
Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)
Based on the occurrence of dose-limiting toxicities (through Day 14)
| Arm | Type | Description |
|---|---|---|
| Crossover Group 1 | EXPERIMENTAL | Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo |
| Crossover Group 2 | EXPERIMENTAL | Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week |
| AMP-110 | EXPERIMENTAL | Escalating doses of AMP-110 |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMP-110 | BIOLOGICAL | 2, 5, or 10 mg/kg |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Must be able to provide written informed consent * Body mass index 18.5 to 35.0 kg/m2 * Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria * Global Functional Class I, II, or III according to ACR 1991 revised criteria * ...