Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (ACCORD-RA)

Sanofi

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: SSR150106; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545454

EudraCT 2007-00760-24

ACT5488

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 3 patient groups, including a placebo group

SSR150106 QD

Experimental group

Description:

90 micro grams oral solution once daily (QD)

Treatment:

Drug: SSR150106

SSR150106 OEQD

Experimental group

Description:

90 micro grams oral solution once every other day (OEQD)

Treatment:

Drug: SSR150106

Placebo

Placebo Comparator group

Description:

oral solution QD or OEQD

Treatment:

Drug: Placebos