A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis (RA) Who Have Failed Previous TNF-α Antagonists

Inclusion Criteria

Inclusion criteria:

- Diagnosis of rheumatoid arthritis ≥6 months duration and American College of
Rheumatology [ACR] Class I-III functional status at screening and baseline visits;

- Active disease defined as:

- At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and
baseline visits, and

- hs-C-Reactive Protein [hs-CRP] >10 g/L or Erythrocyte Sedimentation Rate [ESR]
>28 mm/hr at screening visit;

- Continuous treatment with Methotrexate for at least 12 weeks and on stable dose
(minimum 10 mg/week) for at least 6 weeks prior to the screening visit;

- Patient considered as Primary TNF-α blocker nonresponder. i.e.:

- Appropriate for previous TNF-α blocker therapy

- Lack of adequate clinical response after at least 3 months TNF-α blocker therapy
(up to 2 agents) with Methotrexate or other synthetic disease modifying
anti-rheumatic drug [DMARD] co-therapy.

Exclusion criteria:

- Age <18 years or >75 years;

- Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to
utilize adequate contraception or not to become pregnant during the entire study;

- Fever (>38°C), or chronic, persistent, or recurring infection(s);

- History of demyelinating disease;

- Current underlying hepatobiliary disease.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.