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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00628095 | Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate | PHASE2 | COMPLETED | 100 | — | — | Apr 7, 2008 | Feb 4, 2009 | Apr 4, 2022 | 27 | United States, Chile +5 |
| NCT00446784 | Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis | PHASE1 | COMPLETED | 20 | — | — | Apr 1, 2007 | Aug 1, 2007 | May 23, 2011 | 5 | United States |
ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CE-224,535 | DRUG | 500 mg po BID |
| Placebo | DRUG | no active ingredient |
| Methotrexate | DRUG | - |
Inclusion Criteria: * Active rheumatoid arthritis * Incomplete response to methotrexate Exclusion Criteria: * Must not be on biologic therapies * No recent infections