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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01442545 | A Study to Investigate How JNJ-39758979 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants | PHASE1 | COMPLETED | 21 | — | — | Aug 1, 2011 | Dec 1, 2011 | Mar 13, 2013 | 5 | United States, Germany |
To assess the effect of multiple doses of JNJ-39758979 on blood levels of methotrexate
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| JNJ-39758979 / MTX | DRUG | Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose; Days 3-15: MTX: Route=oral use, single dose of participant's weekly MTX dose and JNJ 39758979: Type=exact, unit=mg, number=300, form=tablet, route=oral use, administered daily. |
Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis Functional Class I-III according to the American College of Rheumatology criteria for at least 3 months prior to Screening * Have been treated with and tolerated oral methotrexate (taken by mouth) for a minimum of 3 months prior to screening, ...