To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Total study duration is up to 34 weeks: Screening up to 28 days, Treatment phase of 24
weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, patients are eligible to enter a long
term safety study (LTS11210) for active treatment wit SAR153191 (REGN88).

Inclusion criteria:

Diagnosis of rheumatoid arthritis ≥6 months duration, according to the American College of
Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis
Classification Criteria.

ACR Class I-III functional status, based on 1991 revised criteria.

Anti-TNF therapy failures, defined by the investigator as patients with an inadequate
clinical response, after being treated for at least 3 consecutive months, and/or
intolerance to at least 1 anti-TNF blocker(s), resulting in or requiring their
discontinuation:

- TNF-blockers may include, but are not limited to, etanercept, infliximab, adalimumab,
golimumab and/or certolizumab.

Moderate-to-severely active rheumatoid arthritis.

Continuous treatment with one or a combination of DMARDs (except for simultaneous
combination use of leflunomide and methotrexate) for at least 12 weeks prior to baseline
and on a stable dose(s) for at least 6 weeks prior to screening:

- Methotrexate - 6 to 25 mg/wk orally or parenterally

- Leflunomide - 10 to 20 mg orally daily

- Sulfasalazine - 1000 to 3000 mg orally daily

- Hydroxychloroquine - 200 to 400 mg orally daily.

Exclusion criteria:

Patients <18 years of age or legal adult age

Past history of, or current, autoimmune or inflammatory systemic or localized joint
disease(s) other than RA.

History of juvenile idiopathic arthritis or arthritis onset prior to age 16.

Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis,
and/or Felty's syndrome.

Treatment with anti-TNF agents, as follows:

- Within 28 days prior to the baseline visit - etanercept

- Within 42 days prior to the baseline visit - infliximab, adalimumab, golimumab,
certolizumab pegol

Treatment with previous RA-directed biologic agents with other than TNF antagonist
mechanisms:

- Within 28 days prior to the randomization (baseline) visit - anakinra

- Within 42 days prior to the randomization (baseline) visit - abatacept

Within 6 months prior to the randomization (baseline) visit - any cell depleting agents
including but not limited to rituximab without a normal lymphocyte and CD 19+ lymphocyte
count.

Treatment with any DMARD other than those allowed per protocol and limited to the maximum
specified dosage within 12 weeks prior to baseline.

Treatment with prednisone >10 mg or equivalent per day, or change in dosage within 4 weeks
prior to baseline visit.

Any parenteral or intra-articular glucocorticoid injection within 4 weeks prior to
baseline.

Prior treatment with anti-IL-6 or IL-6R antagonist therapies, including tocilizumab or
sarilumab, participation in a prior study of sarilumab, irrespective of treatment arm.

Prior treatment with a Janus kinase inhibitor (such as tofacitinib).

New treatment or dose-adjustment to ongoing medication for dyslipidemia within 6 weeks
prior to randomization, ie, stable dose for at least 6 weeks prior to randomization.

Participation in any clinical research study evaluating another investigational drug or
therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP)
administration, whichever is longer.

History of alcohol or drug abuse within 5 years prior to the screening visit.

Patients with a history of malignancy other than adequately-treated carcinoma in-situ of
the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5
years prior to the randomization (baseline) visit. Nonmalignant lymphoproliferative
disorders are also excluded.

Patients with active tuberculosis or latent tuberculosis infection.

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