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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01618955 | Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device | PHASE2 | COMPLETED | 101 | — | — | May 1, 2012 | Jul 1, 2012 | Apr 30, 2014 | 1 | United States |
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following: 1. SC self-injection was administered by the patient 2. SC self-injection was intentional 3. self-injection was administered in an appropriate location on the abdomen 4. patient removed cap marked "1" 5. patient removed cap marked "2" 6. patient held device at injection site for 3 seconds 7. patient confirmed that the window was obstructed
| Arm | Type | Description |
|---|---|---|
| VIBEX MTX | ACTIVE_COMPARATOR | VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status |
| Name | Type | Description |
|---|---|---|
| VIBEX MTX | DEVICE | Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device |
Inclusion Criteria: * Male or female patients \>18 years of age, diagnosed with Rheumatoid Arthritis Exclusion Criteria: * Pregnant females * Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk