EFC18055, Sarilumab, for PMR

Inclusion Criteria:
*  Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
*  Meet criteria for newly diagnosed PMR (newly diagnosed PMR must have met the EULAR/ACR classification criteria for a first-time diagnosis of PMR within 8 weeks prior to randomization) OR for early relapsing PMR (early relapsing PMR must have met the EULAR/ACR classification criteria prior to initiating treatment for PMR) AND
*  Have initiated treatment with corticosteroid(s) (CS) for PMR no more than 1 year prior to randomization,
*  Be on a prednisone dose of at least 7.5 mg/day (or equivalent) and not exceeding 20 mg/day at screening and during the screening period,
*  Have a history of being treated for at least 8 weeks with prednisone (at a dose of ≥10 mg/day prednisone or equivalent),
*  Had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that is ≥5 mg/day (or equivalent) within the past 12 weeks prior to screening: (unequivocal symptoms of PMR flare include shoulder and/or hip girdle pain associated with inflammatory stiffness)
*  Participants must be willing and able to take prednisone of 15 mg/day at randomization
*  Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:
*  Diagnosis of Giant Cell Arteritis (GCA)
*  Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
*  Inadequately treated hypothyroidism
*  Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster
*  Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)
*  Immunosuppressive therapies including systemic corticosteroids
*  Malignancy
*  Organ transplant recipient The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.