drugset / Trial / NCT00545454

Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis

NCT00545454 ↗

Phase 2 Completed 79 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP). The secondary objectives are: * to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American College of Rheumatology response rate, and morning stiffness duration; * to assess the effect on pain relief within first 14 days; * to obtain evidence of the safety and tolerability of SSR150106; * to document trough plasma levels of SSR150106 and its first metabolite.

Timeline

Start
2007-10
Primary completion
2008-06
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject SSR150106 Small molecule 90 ug Oral

Indications