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
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CE-224,535 was studied as a treatment for rheumatoid arthritis, including in patients who had not fully responded to methotrexate. It is a small molecule drug candidate that was developed for the immunology therapeutic area. It is investigational and is not an approved medicine.
CE-224,535 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical trials of the drug in rheumatoid arthritis.
CE-224,535 reached Phase 2 clinical development for rheumatoid arthritis. Three trials have been completed, including one Phase 2 study and two Phase 1 studies, and no trials are currently active. It is an investigational drug and has not been approved for any indication.
Three completed trials studied CE-224,535. NCT00628095 was a Phase 2 trial of a twice daily pill in 100 rheumatoid arthritis patients who had not fully improved with methotrexate. NCT00446784 was a Phase 1 safety study with methotrexate in 20 patients, and NCT00838058 was a Phase 1 study in 11 healthy volunteers.
The three completed CE-224,535 trials enrolled a total of 131 participants. The Phase 2 trial NCT00628095 enrolled 100 patients with rheumatoid arthritis, while the two Phase 1 trials enrolled 20 patients and 11 healthy volunteers respectively. All three studies were randomized, double blind, and controlled.