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

Sanofi79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.