Study of Sarilumab Treatment for Adults 50 and Older with Early Polymyalgia Rheumatica Comparing Two Sarilumab Doses and Placebo with Prednisone Taper

What this Trial Is About

Researchers are studying adults aged 50 years and older with early polymyalgia rheumatica PMR to evaluate the effectiveness and safety of sarilumab combined with a prednisone taper. This randomized, double-blind, placebo-controlled Phase 4 study compares two doses of sarilumab 150 mg and 200 mg every two weeks plus a 52-week prednisone taper against placebo plus the same prednisone taper. The goal is to see if sarilumab offers better remission rates and to assess its safety and tolerability. Participants are randomly assigned to one of three groups placebo with prednisone taper, sarilumab 150 mg every two weeks with prednisone taper, or sarilumab 200 mg every two weeks with prednisone taper. The study includes a screening period followed by baseline and randomization on Day 1. Treatment lasts for 52 weeks with regular study visits, concluding with an end of treatment visit at Week 52 and a final end of study visit at Week 58. During the study, participants will have scheduled visits from screening through Week 58 for treatment administration and assessments. Researchers will monitor remission status at Week 52, adverse events, and changes in disease activity and quality of life measures. Safety evaluations include tracking serious and special interest adverse events and laboratory tests. The total study participation lasts approximately 58 weeks, including treatment and follow-up visits.

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica