Sanofi
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 3, 3-arm study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens. The study will consist of the following visits: Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 44): Receiving study drug (prednisone taper ends at the end of Week 50), Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.
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/…
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous