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

Rheumatoid Arthritis Clinical Trial

— ACCORD-RA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545454
• Other study ID #: ACT5488
• Secondary ID: EudraCT 2007-007
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2007
• Last updated: August 4, 2017
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: August 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Drug:
• SSR150106

• Placebos

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Czechia,  Romania,  Russian Federation,  Slovakia,  Ukraine, 

Outcome

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

External Links

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