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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01618968 | Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device | PHASE2 | COMPLETED | 49 | — | — | May 1, 2012 | Aug 1, 2012 | May 19, 2014 | 1 | United States |
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment
Dose-normalized maximum observed concentration (Cmax) for each treatment
| Arm | Type | Description |
|---|---|---|
| 10 mg Methotrexate (MTX) | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| 15 mg MTX | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| 20 mg MTX | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| 25 mg MTX | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| Name | Type | Description |
|---|---|---|
| MTX | DRUG | * Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group) * Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) * Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) |
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