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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00902486 | INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs | PHASE2 | COMPLETED | 127 | — | — | May 1, 2009 | Jul 1, 2010 | Sep 4, 2018 | 49 | United States, Czechia |
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: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' 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 |
|---|---|---|
| INCB028050 4 mg QD | EXPERIMENTAL | INCB028050 4mg Once daily (QD) |
| INCB028050 7 mg QD | EXPERIMENTAL | INCB028050 7mg QD |
| INCB028050 10 mg QD | EXPERIMENTAL | INCB028050 10mg QD |
| Placebo | PLACEBO_COMPARATOR | Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules. |
| Name | Type | Description |
|---|---|---|
| INCB028050 | DRUG | 4 mg capsules QD |
| Placebo | DRUG | Placebo matching INCB028050 QD |
Inclusion Criteria: * Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD * For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose * For subjects receiving sulfasalazine, they mu...