drugset / Trial / NCT00303563

A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

NCT00303563 ↗

Phase 2 Completed 204 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject P38 Inhibitor (4) Unknown 50 mg Oral
Subject P38 Inhibitor (4) Unknown 150 mg Oral
Subject P38 Inhibitor (4) Unknown 300 mg Oral

Indications