An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

The maximum study duration per patient enrolled in the Main study is 54 weeks broken down as
follows:

- screening/run-in up to a maximum of 24 weeks

- treatment up to a maximum of 24 weeks

- follow-up of 6 weeks after treatment discontinuation.

The maximum study duration per patient enrolled in the Sub-study is 58 weeks broken down as
follows:

- treatment up to a maximum of 52 weeks

- follow-up of 6 weeks after treatment discontinuation.

Inclusion criteria:

- Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.

- Continuous treatment of methotrexate (MTX) 10 - 25 mg/week (or per local labeling
requirements if the dose range differs) for at least 12 weeks before screening visit
and on a stable dose for 8 weeks before screening visit.

- Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high
sensitivity C-reactive protein > 10 mg/L.

Exclusion criteria:

- Age < 18 years.

- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks
of the screening visit.

- Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per
day, or a change in dosage within 4 weeks of the screening visit.

- Prior treatment with a TNF (tumor necrosis factor)-alpha inhibitor, or other
biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.

- New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory
drugs (NSAIDs) or cyclo-oxygenase-2 inhibitors (COX-2 inhibitors within 4 weeks of
the screening visit.

- Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD)
/immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the
screening visit, depending on DMARD.

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