Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CE-224, 535 · 3 trials · 3 indications
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 | - |
| Part1; controlled release formulation 4; 250 mg | EXPERIMENTAL | one 250 mg controlled release tablet, once in the morning, in fasted state |
| Part1; controlled release formulation 4; 500 mg | EXPERIMENTAL | 2x250 mg, once in the morning, in fasted state |
| Part 1; controlled release formula 4; 1000 mg | EXPERIMENTAL | 4x250 mg tabs, once in the morning, in fasted state |
| Part 1; controlled release formulation 4; 500 mg FED | EXPERIMENTAL | 2x250 mg, once in the morning , in fed state |
| Part 2; IR formulation 500mg | EXPERIMENTAL | 4x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1 |
| Part 2; IR formulation, 500 mg FED | EXPERIMENTAL | 4x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1. |
| Part 2; controlled release formulation 5;500 mg, FASTED | EXPERIMENTAL | 2x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1. |
| Part 2; controlled release formulation 5;500 mg, FED | EXPERIMENTAL | 2x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1 |
| Name | Type | Description |
|---|---|---|
| CE-224,535 | DRUG | 500 mg po BID |
| Placebo | DRUG | no active ingredient |
| CE 224,535 | DRUG | 2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state |
| Methotrexate | DRUG | - |
Inclusion Criteria: * Active rheumatoid arthritis * Incomplete response to methotrexate Exclusion Criteria: * Must not be on biologic therapies * No recent infections
CE-224,535 is an investigational small molecule being developed for rheumatoid arthritis. It was studied in patients with rheumatoid arthritis who had not totally improved with methotrexate, as well as in healthy volunteers. It is not approved and remains in clinical development.
CE-224,535 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company sponsored clinical trials of the drug in rheumatoid arthritis.
CE-224,535 is in Phase 2 clinical development. It has completed a Phase 2 trial in rheumatoid arthritis, along with two Phase 1 trials. It is investigational and not approved.
CE-224,535 has completed three trials: NCT00446784, a Phase 1 safety study with methotrexate in rheumatoid arthritis; NCT00628095, a Phase 2 trial in patients not fully improved with methotrexate; and NCT00838058, a Phase 1 study in healthy volunteers. All trials are completed.
CE-224,535 is distinct from CE-224,545. The Phase 1 trial NCT00446784 studied CE-224,545, while the Phase 2 trial NCT00628095 studied CE-224,535. They are separate investigational compounds.