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Sponsor: Sanofi
Conditions: Rheumatoid Arthritis
Interventions: SSR150106, Placebos
Countries: Bulgaria, Croatia, Czechia, Romania, Russia, Slovakia, Ukraine
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.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy * At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min * C-Reactive Protein \>=1.8 mg/dl confirmed during screening period * Non-poor Cytochrome P2D6 metabolizer status Exclusion Criteria: * Functional Rheumatoid Arthritis class IV * Fever * Infections with hepatitis B, or C, or HIV * Presence or history (\<5 years) of cancer * Manifest or latent tuberculosis * Functional abnormalities (including laboratory values) judged as clinically relevant The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
- Sofia, Bulgaria
- Zagreb, Croatia
- Prague, Czechia
- Bucharest, Romania
- Moscow, Russia
- Bratislava, Slovakia
- Kiev, Ukraine