drugset / Trial / NCT00303563
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2006-04
- Primary completion
- 2007-12
- Completion
- 2007-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P38 Inhibitor (4) | Unknown | 50 mg | Oral |
| Subject | P38 Inhibitor (4) | Unknown | 150 mg | Oral |
| Subject | P38 Inhibitor (4) | Unknown | 300 mg | Oral |