Rheumatoid Arthritis Clinical Trial
Official title:
Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (RA): A 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of 90 µg Administered Once Daily and 90 µg Once Every Other Day
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.
n/a
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