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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01450982 | A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants | PHASE1 | COMPLETED | 20 | — | — | Jun 1, 2011 | Oct 1, 2011 | May 6, 2013 | 4 | United States |
To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNJ-38518168 / MTX Day 1: MTX: Route=oral use single dose of participant's weekly MTX dose Days 2-15: MTX: Route=oral use single dose of participant's weekly MTX dose and of JNJ-38518168 Type=exact unit=mg number=100 form=capsule route=oral use administered daily. |
| Name | Type | Description |
|---|---|---|
| JNJ-38518168 / MTX | DRUG | Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose |
Inclusion Criteria: * Have a body mass index (BMI) between 18 and 38 kg/m2 inclusive, and a body weight between 50-110 kg, inclusive * Have a diagnosis of Rheumatoid Arthritis functional class I-III for at least 3 months prior to Screening * Have been treated with and tolerated oral MTX treatment f...