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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02222493 | A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02). | PHASE3 | COMPLETED | 650 | — | — | Aug 26, 2014 | Jun 1, 2017 | May 30, 2018 | 184 | United States, Australia +26 |
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index \[HAQ-DI\]); and C-Reactive Protein (CRP).
| Arm | Type | Description |
|---|---|---|
| PF-06438179 | EXPERIMENTAL | - |
| Infliximab | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-06438179 | BIOLOGICAL | PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. |
| Infliximab | BIOLOGICAL | Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. |
Inclusion Criteria: Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months. At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline. HS-CRP equal or greater than 10 mg/L. Must have received methotrexate for at least 12 ...