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. The drug is administered as a twice-daily pill and is currently in clinical development, with Phase 2 trials completed.
CE-224,535 is being developed by Pfizer, Inc. (NYSE: PFE). The company conducted clinical trials of the drug in patients with rheumatoid arthritis, including a Phase 2 study that enrolled 100 participants across multiple countries.
CE-224,535 is in Phase 2 clinical development. Two Phase 1 trials and one Phase 2 trial have been completed. The drug is investigational and has not been approved by regulatory authorities. It remains in clinical development for rheumatoid arthritis.
CE-224,535 has been studied in three completed clinical trials. NCT00446784 was a Phase 1 safety study with methotrexate in 20 patients. NCT00628095 was a Phase 2 efficacy study in 100 patients. NCT00838058 was a Phase 1 study in 11 healthy volunteers testing different pill versions.
CE-224,535 and CE-224,545 are similar names that appear in clinical trial records. NCT00446784, a Phase 1 study, is titled "Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis," while other trials use CE-224,535. Both names refer to the same investigational drug.