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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02047604 | (C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis | PHASE2 | COMPLETED | 41 | — | — | Dec 1, 2013 | Mar 23, 2017 | Jun 21, 2021 | 12 | United States |
Adverse events data are collected during a 10-week period, which includes 6 weeks of treatment and 4 weeks of follow-up.
| Arm | Type | Description |
|---|---|---|
| Cohort A - SAN-300 0.5 mg/kg QW | EXPERIMENTAL | SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks |
| Cohort B - SAN-300 1.0 mg/kg QW | EXPERIMENTAL | SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks |
| Cohort C - SAN-300 2.0 mg/kg QOW | EXPERIMENTAL | SAN-300 2.0 mg/kg subcutaneous every other week for six weeks |
| Cohort D - SAN-300 4.0 mg/kg QOW | EXPERIMENTAL | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
| Cohort E - SAN-300 4.0 mg/kg QW | EXPERIMENTAL | SAN-300 4.0 mg/kg subcutaneous every other week for six weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo dosing |
| Name | Type | Description |
|---|---|---|
| SAN-300 0.5 mg/kg QW | DRUG | - |
| SAN-300 1.0 mg/kg QW | DRUG | - |
| SAN-300 2.0 mg/kg QOW | DRUG | - |
| SAN-300 4.0 mg/kg QOW | DRUG | - |
| SAN-300 4.0 mg/kg QW | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010 2. 18 to 75 years of age, inclusive, at the time of informed consent 3. Swollen joint count of ≥ 6 (66-joint count) and...