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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.