drugset / Trial / NCT00545454
Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SSR150106 | Small molecule | 90 ug | Oral |