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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00620685 | A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate | PHASE2 | COMPLETED | 27 | — | — | Mar 1, 2008 | Oct 1, 2008 | Nov 8, 2018 | 7 | United States |
| NCT00383188 | An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis | PHASE2 | COMPLETED | 305 | — | — | Dec 15, 2006 | Jul 16, 2008 | Aug 20, 2021 | 48 | Australia, Brazil +10 |
ACR20 responders: participants with greater than or equal to(\>=)20% improvement in tender and swollen 28-joint counts from baseline, \>=20% improvement in at least 3 of 5 measures: Patient's global assessment of arthritis(PGA), physician's global assessment of arthritis, participant's assessment of pain on visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP) in mg/liter (mg/L). PGA:participant assess overall disease activity on VAS, score:0(no arthritis) to 100(extreme arthritis), high score=more arthritis. Physician's global assessment:physician judge participant's overall disease activity on VAS, score:0(no arthritis) to 100millimeter(mm) (extreme arthritis), high score=more arthritis. Pain-VAS:participant assess arthritis pain on 100mm VAS, score:0mm (no pain) to 100mm (extreme pain), high score=more pain. HAQ-DI:functional disability evaluation, score:0 (no difficulty) to 3 (unable to do), high score=more disability.
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablet, once daily for 4 weeks |
| PH-797804 | DRUG | Tablet, 1 mg PH-797804, once daily for 4 weeks |
Inclusion Criteria: * Adult with RA for at least 6 months * Stable weekly dosage of oral methotrexate 12.5- 25 mg/week Exclusion Criteria: * Severe, progressive and/or uncontrolled other disease * Chronic or recent serious infection; current infection * Concomitant use of RA therapy other than me...