Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Total study duration was up to 310 weeks: Up to a 4 week screening period, 24 week randomized
double-blind treatment phase, 276-week open-label extension, and 6 weeks post-treatment final
study visit.

Inclusion criteria:

- Diagnosis of RA ≥3 months duration.

- American College of Rheumatology (ACR) Class I-III functional status.

- Active RA was defined as:

At least 6 of 66 swollen joints and 8 of 68 tender joints, high sensitivity C-reactive
protein (hs-CRP) ≥8 mg/L or ESR ≥28 mm/H, and DAS28-ESR >5.1.

- Participants as per Investigator judgment were either intolerant of, or considered
inappropriate candidates for continued treatment with MTX, or after at least 12 weeks
of continued treatment with MTX, or inadequate responders treated with an adequate MTX
dose for at least 12 weeks.

Exclusion criteria:

- Age <18 years or the legal age of consent in the country of the study site, whichever
was higher.

- Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive
agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine,
sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline
(Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to
baseline (Randomization Visit) or leflunomide within 8 weeks prior to the
Randomization Visit, or 4 weeks after cholestyramine washout.

- Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6
receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.

- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks
prior to screening.

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