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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04230213 | A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis | PHASE3 | COMPLETED | 455 | — | — | Jan 13, 2020 | Jun 22, 2021 | Feb 22, 2024 | 72 | United States, Bosnia and Herzegovina +8 |
| NCT02480153 | A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02). | PHASE3 | COMPLETED | 597 | — | — | Jun 25, 2015 | Dec 6, 2017 | Jan 23, 2019 | 183 | United States, Australia +22 |
Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.
Area under the serum concentration curve from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. The geometric coefficient of variation is expressed in percentage.
ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 | EXPERIMENTAL | Subcutaneous (SC) injection given every other week |
| Treatment Arm 2 | ACTIVE_COMPARATOR | SC injection given every other week |
| PF-06410293 | EXPERIMENTAL | - |
| Adalimumab | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-06410293 | DRUG | SC injection |
| adalimumab | DRUG | SC injection |
Inclusion Criteria: * Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration. * Moderately to severely active RA based on local standard of care. Exclusion Criteria: -Evidence of untreated or inadequately treated latent or active TB.