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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00550043 | A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis | PHASE2 | COMPLETED | 50 | — | — | Oct 1, 2007 | Sep 1, 2008 | Mar 23, 2015 | 15 | United States, Poland |
The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject's assessment of pain, Subject's global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), subject's self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Treatment Group A | EXPERIMENTAL | INCB018424 15 mg twice daily (BID) or matching placebo |
| Cohort 2: Treatment Group B | EXPERIMENTAL | INCB018424 5 mg BID or matching placebo |
| Cohort 2: Treatment Group C | EXPERIMENTAL | INCB018424 25 mg BID or matching placebo |
| Cohort 2: Treatment Group D | EXPERIMENTAL | INCB018424 50 mg once daily (QD) or matching placebo |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, oral |
| Name | Type | Description |
|---|---|---|
| INCB018424 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Established diagnosis of rheumatoid arthritis 2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry. Exclusion Criteria: 1. Patients who hav...