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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SSR150106 QD

90 micro grams oral solution once daily (QD)

Group Type EXPERIMENTAL

SSR150106

Intervention Type DRUG

SSR150106 OEQD

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

Group Type EXPERIMENTAL

SSR150106

Intervention Type DRUG

Placebo

oral solution QD or OEQD

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

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SSR150106

Intervention Type DRUG

Placebos

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No