An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
Summary
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
Timeline
- Start
- 2006-12-15
- Primary completion
- 2008-07-01
- Completion
- 2008-07-16
Outcome
Missed primary endpoint
registry analysis (superiority test); PH-797804, 0.5 mg vs Placebo; p = 0.3131; Difference in percentage 8.05 (95% CI -7.565 to 23.664); Chi-squared NCT00383188 ↗
registry analysis (superiority test); PH-797804, 3 mg vs Placebo; p = 0.1719; Difference in percentage 10.81 (95% CI -4.602 to 26.224); Chi-squared NCT00383188 ↗
registry analysis (superiority test); PH-797804, 6 mg vs Placebo; p = 0.2783; Difference in percentage 9.83 (95% CI -8.123 to 27.799); Chi-squared NCT00383188 ↗
registry analysis (superiority test); PH-797804, 10 mg vs Placebo; p = 0.3381; Difference in percentage 8.92 (95% CI -9.566 to 27.404); Chi-squared NCT00383188 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PH-797804 | Small molecule | 0.5 mg | Oral |
| Subject | PH-797804 | Small molecule | 3 mg | Oral |
| Subject | PH-797804 | Small molecule | 6 mg | Oral |
| Subject | PH-797804 | Small molecule | 10 mg | Oral |