Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration
Summary
Pharmacokinetics (PK) study
Timeline
- Start
- 2011-01
- Primary completion
- 2011-05
- Completion
- 2011-06
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Treatment Arm A vs Treatment Arm B; Test / Reference Ratio 96.24 (90% CI 92.33 to 100.31) NCT01737944 ↗
registry analysis (non-inferiority or equivalence test); Treatment Arm A vs Treatment Arm C; Test / Reference Ratio 101.28 (90% CI 97.17 to 105.56) NCT01737944 ↗
registry analysis (non-inferiority or equivalence test); Treatment Arm A vs Treatment Arm B; Test / Reference Ratio 96.22 (90% CI 92.32 to 100.28) NCT01737944 ↗
registry analysis (non-inferiority or equivalence test); Treatment Arm A vs Treatment Arm C; Test / Reference Ratio 101.14 (90% CI 97.06 to 105.40) NCT01737944 ↗
registry analysis (non-inferiority or equivalence test); Treatment Arm A vs Treatment Arm B; Test / Reference Ratio 96.76 (90% CI 87.93 to 106.47) NCT01737944 ↗
registry analysis (non-inferiority or equivalence test); Treatment Arm A vs Treatment Arm C; Test / Reference Ratio 89.79 (90% CI 81.61 to 98.78) NCT01737944 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 10 mg | Subcutaneous |
| Subject | Methotrexate | Small molecule | 15 mg | Subcutaneous |
| Subject | Methotrexate | Small molecule | 20 mg | Subcutaneous |
| Subject | Methotrexate | Small molecule | 25 mg | Subcutaneous |