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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SSR150106
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSR150106 QD<br>90 micro grams oral solution once daily (QD) | Drug: SSR150106<br> <br> |
| Experimental: SSR150106 OEQD<br>90 micro grams oral solution once every other day (OEQD) | Drug: SSR150106<br> <br> |
| Placebo Comparator: Placebo<br>oral solution QD or OEQD | Drug: Placebos<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean C-Reactive Protein level |  | end of the 4-week double-blind treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, anti-cytokine, anti-chemokine