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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2007-00760-24 |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSR150106 QD | Experimental | 90 micro grams oral solution once daily (QD) |
|
| SSR150106 OEQD | Experimental | 90 micro grams oral solution once every other day (OEQD) |
|
| Placebo | Placebo Comparator | oral solution QD or OEQD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSR150106 | Drug |
| ||
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean C-Reactive Protein level | end of the 4-week double-blind treatment period |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Karel PAVELKA, Prof., MD | Karel PAVELKA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Sofia | Bulgaria | ||||
| Sanofi-Aventis Administrative Office |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
| 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 |
| Zagreb |
| Croatia |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Bucharest | Romania |
| Sanofi-Aventis Administrative Office | Moscow | Russia |
| Sanofi-Aventis Administrative Office | Bratislava | Slovakia |
| Sanofi-Aventis Administrative Office | Kiev | Ukraine |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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