Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis
- Registration Number
- NCT00545454
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSR150106 OEQD SSR150106 90 micro grams oral solution once every other day (OEQD) Placebo Placebos oral solution QD or OEQD SSR150106 QD SSR150106 90 micro grams oral solution once daily (QD)
- Primary Outcome Measures
Name Time Method Change from baseline in mean C-Reactive Protein level end of the 4-week double-blind treatment period
- Secondary Outcome Measures
Name Time Method C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels at all time points measured Improvement responder rates based on the American College of Rheumatology criteria at all time points measured Pain relief (change from baseline) until day 14 Safety and tolerability During the entire study patient's participation Plasma levels of SSR150106 and its first metabolite On a weekly basis during treatment phase, except at the end of the 3rd week
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇦Kiev, Ukraine