Rheumatoid Arthritis Clinical Trial
— ACCORD-RAOfficial title:
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
Verified date | August 2017 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Sanofi-Aventis Administrative Office | Sofia | |
Croatia | Sanofi-Aventis Administrative Office | Zagreb | |
Czechia | Sanofi-Aventis Administrative Office | Praha | |
Romania | Sanofi-Aventis Administrative Office | Bucuresti | |
Russian Federation | Sanofi-Aventis Administrative Office | Moscow | |
Slovakia | Sanofi-Aventis Administrative Office | Bratislava | |
Ukraine | Sanofi-Aventis Administrative Office | Kiev |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Bulgaria, Croatia, Czechia, Romania, Russian Federation, Slovakia, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in mean C-Reactive Protein level | end of the 4-week double-blind treatment period | ||
Secondary | C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels | at all time points measured | ||
Secondary | Improvement responder rates based on the American College of Rheumatology criteria | at all time points measured | ||
Secondary | Pain relief (change from baseline) | until day 14 | ||
Secondary | Safety and tolerability | During the entire study patient's participation | ||
Secondary | Plasma levels of SSR150106 and its first metabolite | On a weekly basis during treatment phase, except at the end of the 3rd week |
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