Condition: Polymyalgia Rheumatica · Sponsor: Sanofi
This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group 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 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
Always discuss trial participation with your own doctor first.
| Denver Arthritis Clinic - Lowry- Site Number : 8400001 | Denver, Colorado, United States | Recruiting |
| Clinical Research of West Florida - Phase I Unit- Site Number : 8400024 | Clearwater, Florida, United States | Recruiting |
| Vitalia Medical Research - Margate- Site Number : 8400021 | Margate, Florida, United States | Recruiting |
| Florida Research Center- Site Number : 8400084 | Miami, Florida, United States | Recruiting |
| Innovia Research Center- Site Number : 8400029 | Miramar, Florida, United States | Recruiting |
| Discovery Clinical Research - Plantation- Site Number : 8400091 | Plantation, Florida, United States | Recruiting |
| Vantage Clinical Trials - Tampa- Site Number : 8400064 | Tampa, Florida, United States | Recruiting |
| Willow Rheumatology and Wellness- Site Number : 8400012 | Willowbrook, Illinois, United States | Recruiting |
| Inspire Santa Fe Medical Group- Site Number : 8400077 | Santa Fe, New Mexico, United States | Recruiting |
| Altoona Center for Clinical Research - Duncansville- Site Number : 8400018 | Duncansville, Pennsylvania, United States | Recruiting |
| Pennsylvania Regional Center for Arthritis and Osteoporosis Research- Site Number : 8400013 | Wyomissing, Pennsylvania, United States | Recruiting |
| West Tennessee Research Institute- Site Number : 8400009 | Jackson, Tennessee, United States | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07286214