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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00650767 | A Study of ARRY-438162 in Patients With Rheumatoid Arthritis | PHASE2 | COMPLETED | 201 | — | — | Mar 1, 2008 | Jul 1, 2009 | Dec 1, 2020 | 35 | United States, Argentina +5 |
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
| Arm | Type | Description |
|---|---|---|
| ARRY-438162 (Schedule 1) | EXPERIMENTAL | - |
| ARRY-438162 (Schedule 2) | EXPERIMENTAL | - |
| ARRY-438162 (Schedule 3) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ARRY-438162, MEK inhibitor; oral | DRUG | multiple dose, single schedule |
| Placebo; oral | DRUG | matching placebo |
Key Inclusion Criteria: * Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug. * Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue ...